FPA150 in Patients With Advanced Solid Tumors | NCT03514121 | Trialant
NCT03514121
Sponsor
Five Prime Therapeutics, Inc.
Status
Terminated
Last Update Posted
Nov 22, 2024Actual
Enrollment
95Actual
Phase
Early Phase 1
Conditions
Breast Cancer
Ovarian Cancer
Endometrial Cancer
Advanced Solid Tumors
Interventions
FPA150
Pembrolizumab
Countries
United States
South Korea
Protocol Section
Identification Module
NCT ID
NCT03514121
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
FPA150-001
Secondary IDs
Not provided
Brief Title
FPA150 in Patients With Advanced Solid Tumors
Official Title
A Phase 1a/1b Study of FPA150, an Anti-B7-H4 Antibody, in Patients With Advanced Solid Tumors
Acronym
FPA150-001
Organization
Five Prime Therapeutics, Inc.INDUSTRY
Status Module
Record Verification Date
Jan 2022
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The Sponsor terminated the study for reasons unrelated to safety.
Expanded Access Info
No
Start Date
Mar 27, 2018Actual
Primary Completion Date
Apr 21, 2021Actual
Completion Date
Apr 21, 2021Actual
First Submitted Date
Mar 27, 2018
First Submission Date that Met QC Criteria
Apr 30, 2018
First Posted Date
May 2, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Mar 14, 2024
Results First Submitted that Met QC Criteria
Sep 30, 2024
Results First Posted Date
Nov 22, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 30, 2024
Last Update Posted Date
Nov 22, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Five Prime Therapeutics, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of FPA150, an anti-B7H4 antibody alone or in combination with pembrolizumab an anti-PD1 antibody in patients with advanced solid tumors. The Phase 1a, open-label, cohort will identify a recommended dose of FPA150 to use for Phase 1a Combination (FPA150 and Pembrolizumab) Safety Lead-in and for Phase 1b monotherapy cohorts.
Detailed Description
This is a Phase 1a/1b open-label, multicenter study to evaluate the dosing, safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of FPA150 as monotherapy and in combination with pembrolizumab, an anti-PD1 antibody, in patients with advanced solid tumors.
This study includes a Phase 1a FPA150 Monotherapy Dose Escalation, Phase 1a Monotherapy Dose Exploration, Phase 1a combination Safety Lead-in (FPA150 + pembrolizumab), a Phase 1b FPA150 Monotherapy Dose Expansion, and a Phase 1b combination Dose Expansion (FPA150 + pembrolizumab).
The Phase 1a Monotherapy Dose Escalation will include an initial accelerated titration design followed by a standard 3+3 dose escalation design until the MTD and/or RD for Phase 1b is determined. The Phase 1a combination Safety Lead-In will start enrolling once the FPA150 monotherapy RD is identified in Phase 1a monotherapy dose escalation and will continue until the FPA150 MTD/RD in combination is identified. Phase 1a FPA150 monotherapy Dose Exploration may include cohorts that may enroll beyond 3 patients whose tumors express high levels of B7-H4 protein and/or have varying levels of B7H4 expression including low (<10% IHC 2+ or 3+ scores) or no expression on their tumor cells (up to 20 additional patients across all dose levels) to further evaluate safety, PK, pharmacodynamics, and clinical activity at that dose (to be conditional upon the dose level clearing DLT criteria).
Phase 1b will be the Dose Expansion (monotherapy and combination) portion of the study.
Enrollment into Phase 1b Dose Expansion will begin after identification of the MTD and/or RD in Phase 1a (monotherapy and Safety Lead-in). Preliminary efficacy will be evaluated in Phase 1b in planned expansion cohorts that include patients with specific tumor types that are B7-H4+ advanced solid tumors.
Conditions Module
Conditions
Breast Cancer
Ovarian Cancer
Endometrial Cancer
Advanced Solid Tumors
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Early Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
95Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1a dose escalation/1b dose expansion
Experimental
The study consists of Phase 1a dose escalation, Phase 1a dose exploration, Phase 1a combination safety-lead-in and Phase 1b dose expansion
Biological: FPA150
Biological: Pembrolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
FPA150
Biological
A monoclonal antibody against B7-H4
Phase 1a dose escalation/1b dose expansion
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1a Monotherapy: Number of Participants Experiencing Grade 3 and Grade 4 Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. Grade 3 and 4 severity ratings were defined as follows:
Grade 3: Severe or medically significant but non-immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; severe AE Grade 4: Life-threatening consequences; urgent intervention indicated
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 9.143 [3.00, 52.00] weeks)
Phase 1a Monotherapy: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
DLTs were defined as any of the following events regardless of attribution (except for those events clearly due to the underlying disease or extraneous causes):
Any Grade 3 or higher non-hematologic toxicity (except Grade 3 nausea, vomiting, and diarrhea) that occurred within the first 21 days of treatment.
Grade 3 nausea, vomiting, diarrhea lasting >72 hours, that occurred within the first 21 days of treatment.
Febrile neutropenia and/or documented infection, Grade 4 neutropenia that lasted more than 7 days, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia accompanied by bleeding within first 21 days of treatment.
Aspartate aminotransferase (AST) / alanine transaminase (ALT) >3 × upper limit of normal (ULN) and concurrent total bilirubin > 2 × ULN that was not related to liver involvement with cancer.
Other Grade 3 laboratory values that did not resolve within 72 hours. Any Grade 4 laboratory value regardless of clinical sequelae
Up to 21 days
Phase 1a Monotherapy: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as an AE that began or worsened in severity after at least one dose of study treatment (FPA150) had been administered. Clinically significant laboratory abnormalities and ECG abnormalities are included as TEAEs.
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 9.143 [3.00, 52.00] weeks)
Secondary Outcomes
Measure
Description
Time Frame
Phase 1a Monotherapy: Number of Participants With ADAs to FPA150
All ADA samples were collected prior to dosing. A baseline ADA-positive patient was defined as a patient who had an ADA positive sample at baseline. Postbaseline treatment induced ADA positive is derived as participants with ADA negative at baseline and ADA positive at any postbaseline timepoint, or ADA positive at baseline and ADA positive with titer of at least 4-fold of the baseline titer at one or more postbaseline timepoint.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria (Phase 1a Monotherapy and Combination Therapy):
Histologically confirmed solid tumors except primary central nervous system (CNS) tumors.
Disease that is unresectable, locally advanced, or metastatic.
Patients must have had progressive disease during or after, or refused, appropriate standard therapy for their tumor type.
All patients must have at least one measurable lesion at baseline according to RECIST v1.1; tumor sites situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
Adequate washout for prior anti-cancer therapy (ie, ≥ 5 half-lives or 4 weeks since the last dose, whichever is shorter).
Availability of archival tumor tissue and consent to providing archival tumor for retrospective biomarker analysis, or willingness to undergo a fresh tumor biopsy during screening (a biopsy is required for patients in the Phase 1a Dose Exploration portion).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Prior radiotherapy must be completed at least 2 weeks before the first dose of study drug.
Prior radiopharmaceuticals (eg strontium, samarium) must be completed at least 8 weeks before the first dose of study drug.
Prior surgery requiring general anesthesia must be completed one week before first study drug administration. Surgery requiring local/epidural must be completed at least 72 hours before first study drug administration.
Screening laboratory values must meet the following criteria:
Neutrophils ≥ 1200 cells/ µL
Platelets ≥ 75 × 103/ µL
Hemoglobin (Hb) ≥ 9.0 g/dL
Serum creatinine < 1.5× ULN or creatinine clearance (CrCl) of ≥ 40 mL/ minute
AST and ALT < 3× ULN (<5ULN in patients with liver metastases)
Bilirubin < 1.5× ULN (except patients with Gilbert's syndrome, who must have total bilirubin < 3 mg/dL)
For Phase 1a Combination Safety Lead-in Patients ONLY:
B7-H4 positive ovarian cancer
or cytologically confirmed diagnosis of recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that is refractory to existing therapy(ies) known to provide clinical benefit
Progressive disease on or after at least two prior regimens of treatment including at least one platinum-containing regimen, or unable to tolerate additional chemotherapy
No prior therapy with an anti-PD1 or PD-L1-directed agent
Inclusion Criteria (Phase 1b monotherapy and combination):
All Inclusion Criteria for Phase 1a (Exception: Phase 1a Inclusion Criterion #1).
Positive for B7-H4 expression in an archival or fresh tumor sample as evaluated by an accompanying validated central laboratory IHC assay. Archival tissue for patients enrolled in Cohort 1b1 (Breast Cancer) must be within 24 months prior to pre-screening.
History of other malignancy is permitted provided it has been definitively treated with no evidence of recurrence within the past 2 years (Exception: Definitively treated non-melanoma skin cancer, lobular cancer in situ, and cervical cancer in situ within 2 years are permitted). Cohort Specific Phase 1b Criteria (monotherapy and combination therapy)
Breast Cancer Cohorts:
TNBC:
Histologically or cytologically confirmed metastatic TNBC
At least two prior lines of systemic chemotherapy with at least one being administered in the metastatic setting
HR+ Breast:
Histologically or cytologically confirmed metastatic HR+ breast carcinoma
Patients must have received at least two prior lines of hormonal therapy
Patients must have received at least one prior line of systemic chemotherapy (in the adjuvant or metastatic setting)
Ovarian Cancer (monotherapy):
Histologically or cytologically confirmed diagnosis of recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that is refractory to existing
Progressive disease on or after at least two prior regimens of treatment including at least one platinum-containing regimen, or unable to tolerate additional chemotherapy
Endometrial Cancer:
Histologically or cytologically confirmed recurrent or persistent endometrial cancer that is refractory to curative or established treatments
Progressive disease on or after at least one prior regimen of systemic chemotherapy, or unable to tolerate systemic chemotherapy
Ovarian Cancer (combination):
Histologically or cytologically confirmed diagnosis of recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that is refractory to existing
Progressive disease on or after at least two prior regimens of treatment including at least one platinum-containing regimen, or unable to tolerate additional chemotherapy
No prior therapy with an anti-PD1 or PD-L1-directed agent
Exclusion Criteria:
Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent daily) must be discontinued at least 2 weeks before the first dose of study drug. Short courses of high dose steroids or continuous low dose (prednisone < 10 mg/day ) are allowed.
Decreased cardiac function with New York Heart Association (NYHA) > Class 2 at screening.
Uncontrolled or significant heart disorder such as unstable angina.
QT interval corrected for heart rate (QTc) per institutional guidelines > 450 msec for males or > 470 msec for females at screening.
Current unresolved infection or history of chronic, active, clinically significant infection (viral, bacterial, fungal, or other) which, in the opinion of the Investigator, would preclude the patient from exposure to a biologic agent or may pose a risk to patient safety.
Any uncontrolled medical condition or psychiatric disorder which, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study participation or interpretation of individual patient results.
Active, known, or suspected autoimmune disease. Patients with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger, are permitted to enroll.
Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS).
Positive test for hepatitis B virus surface antigen (HBsAg) or detectable hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection.
Ongoing adverse effects from prior treatment > Grade 1 (with the exception of Grade 2 alopecia or peripheral neuropathy) based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Symptomatic interstitial lung disease or inflammatory pneumonitis.
Untreated or active CNS or leptomeningeal metastases. Patients are eligible if metastases have been treated and patients are neurologically returned to baseline or neurologically stable (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks before the first dose of study drug.
Evidence of coagulopathy or bleeding diathesis. Patients receiving stable therapeutic doses of anti-coagulants will be permitted.
Transfusion of blood or platelets completed within 72 hours before the first dose of study drug.
Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis
For Cohort 1b1 only: Patients with HER2 positive disease
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
99 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
MD
Amgen
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Honor Health
Scottsdale
Arizona
85258
United States
Cedars-Sinai Medical Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Participants were enrolled at 25 study centers in the United Studies and the Republic of Korea, and participated from 27 March 2018 to 21 April 2021.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
FG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 4, 2019
Mar 14, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Single arm trial with multiple cohorts
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Pembrolizumab
Biological
An anti-PD1 antibody
Phase 1a dose escalation/1b dose expansion
Phase 1b Monotherapy: Number of Participants Experiencing AEs
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect or important medical events. Clinically significant laboratory abnormalities and ECG abnormalities were included as TEAEs.
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 6.35 [3.00, 108.14] weeks)
Phase 1a Combination Safety Lead-In & Phase 1b Combination: Number of Participants Experiencing AEs
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 12.00 [6.00, 36.43] weeks)
Phase 1a Combination Safety Lead-In & Phase 1b Combination: Number of Participants Experiencing Grade 3 and Grade 4 AEs
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 12.00 [6.00, 36.43] weeks)
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 9.143 [3.00, 52.00] weeks)
Phase 1b Monotherapy: Number of Participants With ADAs to FPA150 at Baseline
All ADA samples were collected prior to dosing. A baseline ADA-positive patient was defined as a patient who had an ADA positive sample at baseline. Postbaseline treatment induced ADA positive is derived as participants with ADA negative at baseline and ADA positive at any postbaseline timepoint, or ADA positive at baseline and ADA positive with titer of at least 4-fold of the baseline titer at one or more postbaseline timepoint.
Cycle 1 day 1 pre-dose (baseline)
Phase 1b Monotherapy: Number of Participants With ADAs to FPA150 Postbaseline
All ADA samples were collected prior to dosing. A baseline ADA-positive patient was defined as a patient who had an ADA positive sample at baseline. Postbaseline treatment induced ADA positive is derived as participants with ADA negative at baseline and ADA positive at any postbaseline timepoint, or ADA positive at baseline and ADA positive with titer of at least 4-fold of the baseline titer at one or more postbaseline timepoint.
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 6.35 [3.00, 108.14] weeks)
Phase 1b Monotherapy: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
ORR was defined as the percentage of participants who achieved best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment of tumor lesions per RECIST v1.1. The BOR was the best response documented from first dose until the end of study, first disease progression, death, or start of new anti-cancer therapy, whichever was earlier.
Up to approximately 24 months
Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1
DOR is defined as the time from first onset of response (CR or PR determined by the investigator per RECIST v1.1) that is subsequently confirmed until the onset of progressive disease or death from any cause, whichever comes first. Patients who were alive and progression-free at the time of data analysis were censored at the time of their last assessment for tumor response. DOR was estimated using the Kaplan-Meier method.
Up to approximately 24 months
Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1
PFS defined as time from the first dose of study treatment until the first documentation by the investigator of disease progression per RECIST v1.1 or death from any cause, whichever comes first. Patients who were alive and progression-free at the time of data analysis were censored at the time of their last assessment for tumor response.
Up to approximately 24 months
Phase 1b Combination: PFS Per RECIST v1.1
PFS defined as time from the first dose of study treatment until the first documentation by the investigator of disease progression per RECIST v1.1 or death from any cause, whichever comes first. Patients who were alive and progression-free at the time of data analysis were censored at the time of their last assessment for tumor response.
Up to approximately 24 months
Phase 1b Combination: ORR Per RECIST v1.1
ORR was defined as the percentage of participants who achieved best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment of tumor lesions per RECIST v1.1. The BOR was the best response documented from first dose until the end of study, first disease progression, death, or start of new anti-cancer therapy, whichever was earlier.
Up to approximately 24 months
Phase 1b Combination: DOR Per RECIST v1.1
DOR is defined as the time from first onset of response (CR or PR determined by the investigator per RECIST v1.1) that is subsequently confirmed until the onset of progressive disease or death from any cause, whichever comes first. Patients who were alive and progression-free at the time of data analysis were censored at the time of their last assessment for tumor response. DOR was estimated using the Kaplan-Meier method.
Up to approximately 24 months
Phase 1a Monotherapy: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of FPA150
FPA150 concentration in serum was determined using an enzyme linked immunosorbent assay (ELISA) method and the PK parameters were derived from serum FPA150 concentration-time data using non-compartment analysis.
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
Phase 1a Monotherapy: Time to Reach Maximum Serum Concentration (Tmax) of FPA150
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
Phase 1a Monotherapy: Maximum Serum Concentration (Cmax) of FPA150
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
Phase 1a Monotherapy: Trough Serum Concentration (Ctrough) of FPA150
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
Phase 1a Monotherapy: Terminal Half-Life (T1/2) of FPA150
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
Phase 1b Monotherapy: AUClast of FPA150
Cycle 1 (one cycle = 21 days) day 1 pre-dose, day 1 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks)
Phase 1b Monotherapy: Time to Reach Cmax of FPA150
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 108 weeks
Phase 1b Monotherapy: Cmax of FPA150
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 108 weeks
Phase 1b Monotherapy: Cthrough of FPA150
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 108 weeks
Phase 1b Monotherapy: T1/2 of FPA150 in Days
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 108 weeks
Los Angeles
California
90048
United States
UCLA
Los Angeles
California
90095
United States
Sarcoma Oncology Research Center
Santa Monica
California
90403
United States
Yale Cancer Center
New Haven
Connecticut
06520
United States
Orchard Healthcare Research Inc.
Skokie
Illinois
60077
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Stephenson Cancer Center
Oklahoma City
Oklahoma
73104
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
South Texas Accelerated Research Therapeutics
San Antonio
Texas
78229
United States
Utah Cancer Specialists
Salt Lake City
Utah
84106
United States
Medical Oncology Associates, PS
Spokane
Washington
99208
United States
National Cancer Center
Gyeonggi-do
10408
South Korea
Seoul National University Bundang Hospital
Gyeonggi-do
13620
South Korea
Severance Hospital
Seoul
03722
South Korea
ASAN Medical Center
Seoul
05505
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
FG002
Phase 1a Monotherapy Dose Escalation + Exploration Dose C
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
FG003
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
FG004
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
FG005
Phase 1a Monotherapy Dose Escalation + Exploration Dose F
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
FG006
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
FG007
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
FG008
Phase 1b Monotherapy FPA150 Dose H
Participants with breast, ovarian, or endometrial cancer received FPA150 MTD/RD.
Participants with ovarian cancer received FPA 150 Dose H in combination with pembrolizumab 200 mg IV Q3W during the Phase 1a Safety Lead-in. Participants with ovarian cancer in the Phase 1b Combination received FPA 150 Dose H in combination with pembrolizumab 200 mg IV Q3W.
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG0043 subjects
FG0058 subjects
FG0068 subjects
FG0074 subjects
FG00854 subjectsParticipants in 1b Monotherapy were stratified by cancer type for some data analysis, but they were not considered separate randomization groups.
FG00912 subjects
Received Any Study Treatment
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG0043 subjects
FG0058 subjects
FG0068 subjects
FG0074 subjects
FG00854 subjects
FG00912 subjects
1b Monotherapy (Breast)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00821 subjects
FG0090 subjects
1b Monotherapy (Ovarian)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00817 subjects
FG0090 subjects
1b Monotherapy (Endometrial)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00816 subjects
FG0090 subjects
Phase 1a Combination Safety Lead-In
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0095 subjects
Phase 1b Combination
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0097 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0042 subjects
FG0057 subjects
FG0067 subjects
FG0074 subjects
FG00853 subjects
FG00911 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0052 subjects
FG0061 subjects
FG0071 subjects
FG0087 subjects
FG0092 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Study termination by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Investigator decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Data from the safety population dataset (SAS) which included all participants who received any portion of at least one dose of FPA150.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
BG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
BG002
Phase 1a Monotherapy Dose Escalation + Exploration Dose C
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
BG003
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
BG004
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
BG005
Phase 1a Monotherapy Dose Escalation + Exploration Dose F
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
BG006
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
BG007
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
BG008
Phase 1b Monotherapy FPA150 Dose H
Participants with breast, ovarian, or endometrial cancer received FPA150 MTD/RD.
Participants with ovarian cancer received FPA 150 Dose H in combination with pembrolizumab 200 mg IV Q3W during the Phase 1a Safety Lead-in. Participants with ovarian cancer in the Phase 1b Combination received FPA 150 Dose H in combination with pembrolizumab 200 mg IV Q3W.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0023
BG0031
BG0043
BG0058
BG0068
BG0074
BG00854
BG00912
BG01095
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Phase 1a Monotherapy: Number of Participants Experiencing Grade 3 and Grade 4 Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. Grade 3 and 4 severity ratings were defined as follows:
Grade 3: Severe or medically significant but non-immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; severe AE Grade 4: Life-threatening consequences; urgent intervention indicated
SAS: All participants who have received any portion of at least one dose of FPA150.
Posted
Count of Participants
Participants
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 9.143 [3.00, 52.00] weeks)
ID
Title
Description
OG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
OG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG002
Phase 1a Monotherapy Dose Escalation + Exploration Dose C
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG003
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG004
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG005
Phase 1a Monotherapy Dose Escalation + Exploration Dose F
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG006
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG007
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0023
OG003
Primary
Phase 1a Monotherapy: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
DLTs were defined as any of the following events regardless of attribution (except for those events clearly due to the underlying disease or extraneous causes):
Any Grade 3 or higher non-hematologic toxicity (except Grade 3 nausea, vomiting, and diarrhea) that occurred within the first 21 days of treatment.
Grade 3 nausea, vomiting, diarrhea lasting >72 hours, that occurred within the first 21 days of treatment.
Febrile neutropenia and/or documented infection, Grade 4 neutropenia that lasted more than 7 days, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia accompanied by bleeding within first 21 days of treatment.
Aspartate aminotransferase (AST) / alanine transaminase (ALT) >3 × upper limit of normal (ULN) and concurrent total bilirubin > 2 × ULN that was not related to liver involvement with cancer.
Other Grade 3 laboratory values that did not resolve within 72 hours. Any Grade 4 laboratory value regardless of clinical sequelae
SAS: All participants who have received any portion of at least one dose of FPA150.
Posted
Count of Participants
Participants
Up to 21 days
ID
Title
Description
OG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
OG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Primary
Phase 1a Monotherapy: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as an AE that began or worsened in severity after at least one dose of study treatment (FPA150) had been administered. Clinically significant laboratory abnormalities and ECG abnormalities are included as TEAEs.
SAS: All participants who have received any portion of at least one dose of FPA150.
Posted
Count of Participants
Participants
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 9.143 [3.00, 52.00] weeks)
ID
Title
Description
OG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
OG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG002
Phase 1a Monotherapy Dose Escalation + Exploration Dose C
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
Primary
Phase 1b Monotherapy: Number of Participants Experiencing AEs
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect or important medical events. Clinically significant laboratory abnormalities and ECG abnormalities were included as TEAEs.
SAS: All participants who have received any portion of at least one dose of FPA150.
Posted
Count of Participants
Participants
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 6.35 [3.00, 108.14] weeks)
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Primary
Phase 1a Combination Safety Lead-In & Phase 1b Combination: Number of Participants Experiencing AEs
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
SAS: All participants who have received any portion of at least one dose of FPA150.
Posted
Count of Participants
Participants
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 12.00 [6.00, 36.43] weeks)
Participants in Phase 1a received a combination of FPA150 20mg/kg and pembrolizumab 200mg Q3W. If DLTs were observed the dose of FPA150 was reduced.
Participants in Phase 1b received FPA150 20mg/kg in combination with pembrolizumab 200mg Q3W.
Units
Counts
Primary
Phase 1a Combination Safety Lead-In & Phase 1b Combination: Number of Participants Experiencing Grade 3 and Grade 4 AEs
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
SAS: All participants who have received any portion of at least one dose of FPA150.
Posted
Count of Participants
Participants
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 12.00 [6.00, 36.43] weeks)
Participants in Phase 1a received a combination of FPA150 20mg/kg and pembrolizumab 200mg Q3W. If DLTs were observed the dose of FPA150 was reduced.
Participants in Phase 1b received a combination of FPA150 20mg/kg in combination with pembrolizumab 200mg Q3W.
Units
Counts
Secondary
Phase 1a Monotherapy: Number of Participants With ADAs to FPA150
All ADA samples were collected prior to dosing. A baseline ADA-positive patient was defined as a patient who had an ADA positive sample at baseline. Postbaseline treatment induced ADA positive is derived as participants with ADA negative at baseline and ADA positive at any postbaseline timepoint, or ADA positive at baseline and ADA positive with titer of at least 4-fold of the baseline titer at one or more postbaseline timepoint.
ADA Analysis Set: The ADA Analysis Set included all enrolled participants who received at least 1 dose of FPA150 and had at least 1 ADA sample drawn at any timepoint.
Posted
Count of Participants
Participants
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 9.143 [3.00, 52.00] weeks)
ID
Title
Description
OG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
OG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG002
Secondary
Phase 1b Monotherapy: Number of Participants With ADAs to FPA150 at Baseline
All ADA samples were collected prior to dosing. A baseline ADA-positive patient was defined as a patient who had an ADA positive sample at baseline. Postbaseline treatment induced ADA positive is derived as participants with ADA negative at baseline and ADA positive at any postbaseline timepoint, or ADA positive at baseline and ADA positive with titer of at least 4-fold of the baseline titer at one or more postbaseline timepoint.
ADA Analysis Set: The ADA Analysis Set included all enrolled participants who received at least 1 dose of FPA150 and had at least 1 ADA sample drawn at any timepoint.
Posted
Count of Participants
Participants
Cycle 1 day 1 pre-dose (baseline)
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Monotherapy: Number of Participants With ADAs to FPA150 Postbaseline
All ADA samples were collected prior to dosing. A baseline ADA-positive patient was defined as a patient who had an ADA positive sample at baseline. Postbaseline treatment induced ADA positive is derived as participants with ADA negative at baseline and ADA positive at any postbaseline timepoint, or ADA positive at baseline and ADA positive with titer of at least 4-fold of the baseline titer at one or more postbaseline timepoint.
ADA Analysis Set: The ADA Analysis Set included all enrolled participants who received at least 1 dose of FPA150 and had at least 1 ADA sample drawn at any timepoint.
Posted
Count of Participants
Participants
From day 1 up to 28 days after last dose (median [min, max] treatment duration= 6.35 [3.00, 108.14] weeks)
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Monotherapy: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
ORR was defined as the percentage of participants who achieved best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment of tumor lesions per RECIST v1.1. The BOR was the best response documented from first dose until the end of study, first disease progression, death, or start of new anti-cancer therapy, whichever was earlier.
Efficacy-Evaluable Analysis Set: included all participants that received at least 1 dose of FPA150, had at least 1 postbaseline evaluable tumor assessment unless death or clinical progressive disease occurred prior to the first post baseline disease assessment.
Posted
Count of Participants
Participants
Up to approximately 24 months
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1
DOR is defined as the time from first onset of response (CR or PR determined by the investigator per RECIST v1.1) that is subsequently confirmed until the onset of progressive disease or death from any cause, whichever comes first. Patients who were alive and progression-free at the time of data analysis were censored at the time of their last assessment for tumor response. DOR was estimated using the Kaplan-Meier method.
Efficacy-Evaluable Analysis Set: included all participants that received at least 1 dose of FPA150, had at least 1 postbaseline evaluable tumor assessment unless death or clinical progressive disease occurred prior to the first post baseline disease assessment. Only responders have been included in the analysis.
Posted
Number
90% Confidence Interval
months
Up to approximately 24 months
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1
PFS defined as time from the first dose of study treatment until the first documentation by the investigator of disease progression per RECIST v1.1 or death from any cause, whichever comes first. Patients who were alive and progression-free at the time of data analysis were censored at the time of their last assessment for tumor response.
Efficacy-Evaluable Analysis Set: included all participants that received at least 1 dose of FPA150, had at least 1 postbaseline evaluable tumor assessment unless death or clinical progressive disease occurred prior to the first post baseline disease assessment.
Posted
Mean
90% Confidence Interval
months
Up to approximately 24 months
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Combination: PFS Per RECIST v1.1
PFS defined as time from the first dose of study treatment until the first documentation by the investigator of disease progression per RECIST v1.1 or death from any cause, whichever comes first. Patients who were alive and progression-free at the time of data analysis were censored at the time of their last assessment for tumor response.
No PFS data for Phase 1b combination was collected due to study early termination. Data for phase 1a were considered exploratory.
Posted
Up to approximately 24 months
ID
Title
Description
OG000
Phase 1b Combination
Participants in Phase 1b received FPA150 20mg/kg in combination with pembrolizumab 200mg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Combination: ORR Per RECIST v1.1
ORR was defined as the percentage of participants who achieved best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment of tumor lesions per RECIST v1.1. The BOR was the best response documented from first dose until the end of study, first disease progression, death, or start of new anti-cancer therapy, whichever was earlier.
No ORR data for Phase 1b combination was collected due to study early termination. Data for phase 1a were considered exploratory.
Posted
Up to approximately 24 months
ID
Title
Description
OG000
Phase 1b Combination
Participants in Phase 1b received FPA150 20mg/kg in combination with pembrolizumab 200mg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Combination: DOR Per RECIST v1.1
DOR is defined as the time from first onset of response (CR or PR determined by the investigator per RECIST v1.1) that is subsequently confirmed until the onset of progressive disease or death from any cause, whichever comes first. Patients who were alive and progression-free at the time of data analysis were censored at the time of their last assessment for tumor response. DOR was estimated using the Kaplan-Meier method.
No DOR data for Phase 1b combination was collected due to study early termination. Data for phase 1a were considered exploratory.
Posted
Up to approximately 24 months
ID
Title
Description
OG000
Phase 1b Combination
Participants in Phase 1b received FPA150 20mg/kg in combination with pembrolizumab 200mg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1a Monotherapy: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of FPA150
FPA150 concentration in serum was determined using an enzyme linked immunosorbent assay (ELISA) method and the PK parameters were derived from serum FPA150 concentration-time data using non-compartment analysis.
PK Analysis Population: All participants who received at least one dose of FPA150 and had at least one FPA150 serum concentration result. Only participants with available data are included. Participants with available data are included.
Posted
Mean
Standard Deviation
day*µg/mL
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
ID
Title
Description
OG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
OG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
Secondary
Phase 1a Monotherapy: Time to Reach Maximum Serum Concentration (Tmax) of FPA150
PK Analysis Population: All participants who received at least one dose of FPA150 and had at least one FPA150 serum concentration result. Only participants with available data are included.
Posted
Mean
Standard Deviation
Days
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
ID
Title
Description
OG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
OG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG002
Phase 1a Monotherapy Dose Escalation + Exploration Dose C
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
Secondary
Phase 1a Monotherapy: Maximum Serum Concentration (Cmax) of FPA150
PK Analysis Population: All participants who received at least one dose of FPA150 and had at least one FPA150 serum concentration result. Only participants with available data are included. Participants with available data are included.
Posted
Mean
Standard Deviation
μg/mL
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
ID
Title
Description
OG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
OG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG002
Phase 1a Monotherapy Dose Escalation + Exploration Dose C
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
Secondary
Phase 1a Monotherapy: Trough Serum Concentration (Ctrough) of FPA150
PK Analysis Population: All participants who received at least one dose of FPA150 and had at least one FPA150 serum concentration result. Only participants with available data are included.
Posted
Mean
Standard Deviation
µg/mL
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
ID
Title
Description
OG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
OG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG002
Phase 1a Monotherapy Dose Escalation + Exploration Dose C
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
Secondary
Phase 1a Monotherapy: Terminal Half-Life (T1/2) of FPA150
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
Posted
Mean
Standard Deviation
day
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 52 weeks
ID
Title
Description
OG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
OG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
OG002
Phase 1a Monotherapy Dose Escalation + Exploration Dose C
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
Secondary
Phase 1b Monotherapy: AUClast of FPA150
PK Analysis Population: All participants who received at least one dose of FPA150 and had at least one FPA150 serum concentration result.
Posted
Mean
Standard Deviation
Day*µg/mL
Cycle 1 (one cycle = 21 days) day 1 pre-dose, day 1 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks)
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Monotherapy: Time to Reach Cmax of FPA150
PK Analysis Population: All participants who received at least one dose of FPA150 and had at least one FPA150 serum concentration result.
Posted
Mean
Standard Deviation
day
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 108 weeks
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Monotherapy: Cmax of FPA150
PK Analysis Population: All participants who received at least one dose of FPA150 and had at least one FPA150 serum concentration result.
Posted
Mean
Standard Deviation
µg/mL
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 108 weeks
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Monotherapy: Cthrough of FPA150
PK Analysis Population: All participants who received at least one dose of FPA150 and had at least one FPA150 serum concentration result.
Posted
Mean
Standard Deviation
µg/mL
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 108 weeks
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Secondary
Phase 1b Monotherapy: T1/2 of FPA150 in Days
PK Analysis Population: All participants who received at least one dose of FPA150 and had at least one FPA150 serum concentration result.
Posted
Mean
Standard Deviation
day
Cycle 1 (cycle = 21 days) day 1 pre-dose, 15min and 4h post-dose, day 2 (24h), day 4 (72h), day 8 (168h) post-dose, and day 15. Cycle 2, 3, 4 ,5 ,7, 9, day 1 pre-dose, day 1 (15min) post-dose. After cycle 9, day 1 every 4th dose (12 weeks) up to 108 weeks
ID
Title
Description
OG000
Phase 1b Monotherapy
Participants with breast, ovarian, or endometrial cancer received FPA150 20mg/kg Q3W.
Units
Counts
Participants
OG000
Time Frame
Adverse events were collected through 28 days after last dose of study drug. Median (min, max) duration of exposure was 9.14 [3.0, 52.0] weeks for the Phase 1a Dose Escalation + Explorations part of the study, 6.36 [3.0, 108.1] weeks for the Phase 1b Monotherapy part and 12.00 [6.0, 36.4] weeks for the Phase 1a combination lead-in and Phase 1b combination.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A
Participants with advanced solid tumors received FPA150 once every 3 weeks (Q3W) in escalating doses (Dose A-H) until the maximum tolerated dose (MTD) and/or recommended dose (RD) for Phase 1b was determined.
0
1
1
1
1
1
EG001
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
0
1
0
1
1
1
EG002
Phase 1a Monotherapy Dose Escalation + Exploration Dose C
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
0
3
0
3
3
3
EG003
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
0
1
0
1
1
1
EG004
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
0
3
1
3
3
3
EG005
Phase 1a Monotherapy Dose Escalation + Exploration Dose F
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
3
8
1
8
7
8
EG006
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
2
8
3
8
7
8
EG007
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H
Participants with advanced solid tumors received FPA150 Q3W in escalating doses until MTD and/or RD for Phase 1b was determined.
1
4
0
4
4
4
EG008
Phase 1b Monotherapy FPA150 Dose H (Breast)
Participants with breast, ovarian, or endometrial cancer received FPA150 MTD/RD.
9
21
3
21
16
21
EG009
Phase 1b Monotherapy FPA150 Dose H (Ovarian)
Participants with breast, ovarian, or endometrial cancer received FPA150 MTD/RD.
10
17
6
17
14
17
EG010
Phase 1b Monotherapy FPA150 Dose H (Endometrial)
Participants with breast, ovarian, or endometrial cancer received FPA150 MTD/RD.
Participants with ovarian cancer received FPA 150 Dose H in combination with pembrolizumab 200 mg IV Q3W during the Phase 1a Safety Lead-in. Participants with ovarian cancer in the Phase 1b Combination received FPA 150 Dose H in combination with pembrolizumab 200 mg IV Q3W.
3
12
3
12
11
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac arrest
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected21 at risk
EG0090 affected17 at risk
EG0101 affected16 at risk
EG0110 affected12 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Enterobacter bacteraemia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0052 affected8 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0082 affected21 at risk
EG0093 affected17 at risk
EG0104 affected16 at risk
EG0113 affected12 at risk
Tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Ear pruritus
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Eye haematoma
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Anal inflammation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Gingival recession
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Catheter site erythema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Generalised oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Localised oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Swelling
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Psoas abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Troponin increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Aphonia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pyelocaliectasis
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Lichen sclerosus
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.