Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GE... | NCT03267940 | Trialant
NCT03267940
Sponsor
Halozyme Therapeutics
Status
Terminated
Last Update Posted
Feb 7, 2020Actual
Enrollment
85Actual
Phase
Phase 1
Conditions
Cholangiocarcinoma Non-resectable
Cholangiocarcinoma, Intrahepatic
Cholangiocarcinoma, Extrahepatic
Gallbladder Adenocarcinoma
Interventions
PEGPH20
CIS
GEM
Atezolizumab
Countries
United States
South Korea
Thailand
Protocol Section
Identification Module
NCT ID
NCT03267940
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
Halo-110-101
Secondary IDs
Not provided
Brief Title
Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Official Title
A Phase 1B, Randomized, Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Cisplatin Plus Gemcitabine and PEGPH20 in Combination With Atezolizumab and Cisplatin Plus Gemcitabine Compared With Cisplatin Plus Gemcitabine in Subjects With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Acronym
Not provided
Organization
Halozyme TherapeuticsINDUSTRY
Status Module
Record Verification Date
Jan 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decision
Expanded Access Info
No
Start Date
Oct 2, 2017Actual
Primary Completion Date
Nov 11, 2019Actual
Completion Date
Nov 11, 2019Actual
First Submitted Date
Jul 25, 2017
First Submission Date that Met QC Criteria
Aug 28, 2017
First Posted Date
Aug 31, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jan 24, 2020
Results First Submitted that Met QC Criteria
Jan 24, 2020
Results First Posted Date
Feb 7, 2020Actual
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
Jan 24, 2020
Last Update Posted Date
Feb 7, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Halozyme TherapeuticsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
The study is being conducted to assess the safety and tolerability of (1) PEGPH20 in combination with CIS and GEM (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and atezolizumab (PEGCISGEMATEZO) compared with (3) cisplatin and gemcitabine (CISGEM).
Detailed Description
The study will have a Run-in portion and an Expansion portion. The Run-in portion will be used to evaluate the safety profile of the PEGCISGEM and PEGCISGEMATEZO treatments prior to evaluating the efficacy and safety of PEGCISGEM and PEGCISGEMATEZO treatments compared with CISGEM treatment in the Expansion portion of the study. Treatment in both portions of the study will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
Conditions Module
Conditions
Cholangiocarcinoma Non-resectable
Cholangiocarcinoma, Intrahepatic
Cholangiocarcinoma, Extrahepatic
Gallbladder Adenocarcinoma
Keywords
Extrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
Gallbladder Adenocarcinoma
PEGylated Recombinant Human Hyaluronidase
PEGylated Recombinant Human Hyaluronidase with atezolizumab
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
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
85Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Run-in Portion: PEGCISGEM
Experimental
Participants will receive 3.0 micrograms per kilogram (mcg/kg) PEGPH20 on Days 1, 8, and 15 in combination with 25 milligrams per meter square (mg/m^2) of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by intravenous (IV) infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
Drug: PEGPH20
Drug: CIS
Drug: GEM
Run-in Portion: PEGCISGEMATEZO
Experimental
After 6 participants from the PEGCISGEM arm are treated for at least 1 cycle without significant toxicities, new participants will be enrolled in this arm to receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
Drug: PEGPH20
Drug: CIS
Drug: GEM
Drug: Atezolizumab
Expansion Portion: PEGCISGEM
Experimental
After the Investigators and the Sponsor considers the study treatment with PEGCISGEM during the Run-in portion safe and tolerable, new participants will be enrolled to receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
Drug: PEGPH20
Drug: CIS
Drug: GEM
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PEGPH20
Drug
PEGPH20 will be administered as per the schedule specified in the respective arms.
Expansion Portion: PEGCISGEM
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Run-in Portion: Number of Participants With Adverse Events (AEs)
An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days)
Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry)
Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, white blood cell [WBC] count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, blood urea nitrogen [BUN], albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase [AST], alanine aminotransferase [ALT], electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)
Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs
Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Secondary Outcomes
Measure
Description
Time Frame
Run-in Portion: ORR Based on RECIST v1.1: Percentage of Participants With Objective Response
ORR was defined as percentage of participants who achieved either a CR or PR. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For both portions of the study, participants must satisfy all of the following inclusion criteria to be enrolled in the study:
Written Institutional Review Board/Ethics Committee-approved informed consent form (ICF), signed by participant or legally authorized representative.
Participants must be determined to have histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the intra- and/or extra-hepatic bile ducts and/or gallbladder. Participants must have sufficient tissue with architectural integrity, including tumor and associated stroma, available for retrospective biomarker testing.
One or more lesions measurable on computed tomography (CT) scan/magnetic resonance imaging (MRI) scan per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1).
Participants having Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Life expectancy ≥3 months.
Males and females aged ≥18 years.
Screening clinical laboratory values within pre-determined parameters
Female participants of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days before Day 1 (first dose of study medication).
For WOCBP and for men, agreement to use a highly effective contraceptive method from the time of screening throughout the study until 5 months (WOCBP) or 6 months (men) after administration of the last dose of any study medication. Highly effective contraceptive methods consist of prior sterilization, intrauterine device (IUD), intrauterine hormone releasing system (IUS), oral or injectable contraceptives, barrier methods, and/or true sexual abstinence.
Exclusion Criteria:
Participants are ineligible for enrollment if they meet any of the following exclusion criteria:
Clinical evidence of deep vein thrombosis or pulmonary embolism present during the screening period
New York Heart Association Class III or IV cardiac disease, atrial fibrillation, unstable angina, or myocardial infarction within the past 12 months before screening.
Participants with known brain metastases
History of cerebrovascular accident or transient ischemic attack
History of active bleeding within the last 3 months prior to screening requiring transfusion.
Participants must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for treatment of metastatic or locally advanced disease.
Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs).
Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening
Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening
History of:
Idiopathic pulmonary fibrosis, organizing pneumonia (for example, bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Or known cases of hepatobiliary diseases (for example, primary biliary cholangitis, primary sclerosing cholangitis, history of immune-mediated cholangitis);
Participants with cholangitis attributed to infectious etiology (for example, ascending cholangitis, bacterial cholangitis) are eligible if the infection has been fully resolved prior to the screening visit.
Or known cases of drug-induced hepatobiliary toxicities.
Active or history of autoimmune diseases
Uncontrolled hypercalcemia
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
VP, Medical, Regulatory and Drug Safety
Halozyme Therapeutics
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Mayo Clinic of Arizona
Phoenix
Arizona
85054
United States
University of Arizona
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The study was terminated prematurely by the Sponsor due to stopping the clinical development of PEGPH20 in all indications based on negative pivotal data in metastatic pancreatic cancer.
Recruitment Details
The study was conducted in 2 portions: Run-in portion and Expansion portion.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Run-in Portion: PEGCISGEM
Participants received 3.0 micrograms per kilogram (mcg/kg) PEGPH20 on Days 1, 8, and 15 in combination with 25 milligrams per meter square (mg/m^2) of cisplatin (CIS) plus 1000 mg/m^2 of gemcitabine (GEM) administered on Days 2 and 9 of each 21-day cycle by intravenous (IV) infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
Periods
Title
Milestones
Reasons Not Completed
Run-in Portion (Max. Exposure: 508 Days)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Yes
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
Apr 9, 2019
Jan 24, 2020
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
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
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
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Experimental
After the Investigators and the Sponsor considers the study treatment with PEGCISGEM during the Run-in portion safe and tolerable, new participants will be enrolled to receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
Drug: PEGPH20
Drug: CIS
Drug: GEM
Drug: Atezolizumab
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Experimental
After the implementation of Protocol Amendment #3 and as communicated to the Investigators via a letter dated 22 March 2019, participants will receive 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants will receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
Drug: PEGPH20
Drug: CIS
Drug: GEM
Drug: Atezolizumab
Expansion Portion: CISGEM
Active Comparator
After the Investigators and the Sponsor considers the study treatment with PEGCISGEM during the run-in portion safe and tolerable, new participants will be enrolled to receive 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
Drug: CIS
Drug: GEM
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Run-in Portion: PEGCISGEM
Run-in Portion: PEGCISGEMATEZO
CIS
Drug
CIS will be administered as per the schedule specified in the respective arms.
Expansion Portion: CISGEM
Expansion Portion: PEGCISGEM
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Run-in Portion: PEGCISGEM
Run-in Portion: PEGCISGEMATEZO
GEM
Drug
GEM will be administered as per the schedule specified in the respective arms.
Expansion Portion: CISGEM
Expansion Portion: PEGCISGEM
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Run-in Portion: PEGCISGEM
Run-in Portion: PEGCISGEMATEZO
Atezolizumab
Drug
Atezolizumab will be administered as per the schedule specified in the respective arms.
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Run-in Portion: PEGCISGEMATEZO
From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)
Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication
Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)
Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response
ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 421 days)
From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 508 days)
Expansion Portion: Duration of Response (DOR) Based on RECIST v1.1
DOR was considered the time from date of the first CR or PR until the date of first documentation of disease progression or date of death based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
From date of the first CR or PR until the date of first documentation of disease progression or date of death, whichever came first (maximum exposure: 421 days)
Expansion Portion: Progression-Free Survival (PFS) Based on RECIST v1.1
PFS was based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review and was defined as the time from randomization to radiological disease progression or death. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on or prior to the current assessment (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of greater than or equal to (≥) 5 mm.
From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)
Expansion Portion: Disease Control Rate (DCR) Based on RECIST v1.1: Percentage of Participants With CR, PR or Stable Disease (SD)
DCR was defined as the percentage of participants with CR, PR, or SD based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)
Expansion Portion: Overall Survival (OS)
Overall survival was defined as the time from randomization until death from any cause.
From randomization until death from any cause (maximum exposure: 421 days)
Expansion Portion: OS by PD-L1 Expression Levels
Overall survival was defined as the time from randomization until death from any cause.
From randomization until death from any cause (maximum exposure: 421 days)
Expansion Portion: Number of Participants With AEs
An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)
Expansion Portion: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters (Hematology and Blood Chemistry)
Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, WBC count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, BUN, albumin, total bilirubin, alkaline phosphatase, AST, ALT, electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)
Expansion Portion: Number of Participants With Clinically Significant Abnormalities in ECG and Vital Signs
Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)
Expansion Period: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication
Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 421 days)
Run-in and Expansion Portion : Maximum Observed Plasma Concentration (Cmax) of PEGPH20, ATEZO, GEM, and CIS
Plasma pharmacokinetic (PK) data were planned to be analyzed using a noncompartmental analysis approach.
PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and end of treatment (EOT) (maximum exposure: 508 days for run-in and 421 days for expansion); CIS and GEM: Cycle 1: multiple timepoints on Days 2,9
Run-in and Expansion Portion : Minimum Observed Plasma Concentration (Cmin) of PEGPH20 and ATEZO
PK data were planned to be analyzed using a noncompartmental analysis approach.
PEGPH20 and ATEZO: Treatment Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15; ATEZO: Day 1 of subsequent cycles and EOT visit (7 days after last 21-day cycle) (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Run-in and Expansion Portion : Elimination Rate Constant (Kel) of PEGPH20
PK data were planned to be analyzed using a noncompartmental analysis approach.
Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15
Run-in and Expansion Portion : Terminal Elimination Plasma Half-life (t1/2) of PEGPH20, ATEZO, GEM, and CIS
PK data were planned to be analyzed using a noncompartmental analysis approach.
PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
Run-in and Expansion Portion : Clearance (CL) of PEGPH20, ATEZO, GEM, and CIS
PK data were planned to be analyzed using a noncompartmental analysis approach.
PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
Run-in and Expansion Portion : Volume of Distribution (Vd) of PEGPH20, ATEZO, GEM, and CIS
PK data were planned to be analyzed using a noncompartmental analysis approach.
PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
Run-in and Expansion Portion: Area Under the Concentration Time Curve (AUC) of PEGPH20, ATEZO, GEM, and CIS
PK data were planned to be analyzed using a noncompartmental analysis approach.
PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
Tucson
Arizona
85724
United States
City of Hope
Duarte
California
91010
United States
Scripps
La Jolla
California
92037
United States
USC/Norris Comprehensive Cancer Center
Los Angeles
California
90033
United States
University of California Irvine Division of Hematology-Oncology, Department of Medicine UC Irvine Health
Orange
California
92868
United States
UC Davis
Sacramento
California
95817
United States
UCLA - David Geffen School of Medicine
Santa Monica
California
90404
United States
The Oncology Institute of Hope and Innovation
Whittier
California
90603
United States
Yale Cancer Center
New Haven
Connecticut
06511
United States
Lombardi Cancer Center, Georgetown University
Washington D.C.
District of Columbia
20007
United States
Johns Hopkins
Baltimore
Maryland
21287
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Mount Sinai
New York
New York
10029
United States
University of Rochester Medical Center
Rochester
New York
14642
United States
Duke Cancer Institute
Durham
North Carolina
27710
United States
Gabrail Cancer Center
Canton
Ohio
44718
United States
University of Pittsburgh Cancer Institute
Pittsburgh
Pennsylvania
15232
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
UT Health Cancer Center
San Antonio
Texas
78229
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
Virginia Mason
Seattle
Washington
98101
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
Froedtert Hospital And Medical College
Milwaukee
Wisconsin
53226
United States
Samsung Medical Center
Seoul
Gangnam-gu
06351
South Korea
Korea University Guro Hospital
Seoul
Guro-gu
08308
South Korea
Seoul National University Bundang Hospital
Seongnam-si
Gyeonggi-do
13620
South Korea
Seoul National University Hospital
Seoul
Jongno-gu
03080
South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
Seocho-gu
06591
South Korea
Severance Hospital, Yonsei University Health System
Seoul
Seodaemun-Gu
03722
South Korea
Asan Medical Center
Seoul
Songpa-gu
05505
South Korea
Prince of Songkla University
Hat Yai
Changwat Songkhla
90110
Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
Muang
50200
Thailand
King Chulalongkorn Memorial Hospital
Bangkok
Patumwan
10330
Thailand
FG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg atezolizumab (ATEZO) (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
FG002
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
FG003
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
FG004
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
FG005
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
FG0009 subjects
FG0019 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Received at Least 1 Dose of Study Drug
FG0009 subjects
FG0019 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0008 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Investigator or Sponsor Decision
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Terminated Study
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0007 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Expansion (Maximum Exposure: 421 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00224 subjects
FG00322 subjects
FG00411 subjects
FG00510 subjects
Received at Least 1 Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG00224 subjects
FG00322 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00221 subjects
FG00322 subjects
FG004
Type
Comment
Reasons
Other than specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Enrolled population included all participants enrolled in the Run-in portion and the Expansion portion of the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
BG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
BG002
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
BG003
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
BG004
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
BG005
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG0019
BG00224
BG00322
BG00411
BG00510
BG00685
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
BG0006
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
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
Run-in Portion: Number of Participants With Adverse Events (AEs)
An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Safety population included all participants who received any study medication.
Posted
Count of Participants
Participants
From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days)
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
Units
Counts
Participants
OG0009
OG0019
Title
Denominators
Categories
Title
Measurements
OG0009
OG0019
Primary
Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry)
Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, white blood cell [WBC] count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, blood urea nitrogen [BUN], albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase [AST], alanine aminotransferase [ALT], electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Safety population included all participants who received any study medication.
Posted
Count of Participants
Participants
From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Primary
Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs
Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Data for this outcome measure was not collected due to early termination of study.
Posted
From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
Primary
Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication
Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Safety population included all participants who received any study medication.
Posted
Count of Participants
Participants
From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Primary
Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response
ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Data for this outcome measure was not collected due to early termination of study.
Posted
From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 421 days)
ID
Title
Description
OG000
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG001
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
Secondary
Run-in Portion: ORR Based on RECIST v1.1: Percentage of Participants With Objective Response
ORR was defined as percentage of participants who achieved either a CR or PR. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Data for this outcome measure was not Collected due to early termination of study.
Posted
From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 508 days)
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
Secondary
Expansion Portion: Duration of Response (DOR) Based on RECIST v1.1
DOR was considered the time from date of the first CR or PR until the date of first documentation of disease progression or date of death based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Data for this outcome measure was not collected due to early termination of study.
Posted
From date of the first CR or PR until the date of first documentation of disease progression or date of death, whichever came first (maximum exposure: 421 days)
ID
Title
Description
OG000
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG001
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
Secondary
Expansion Portion: Progression-Free Survival (PFS) Based on RECIST v1.1
PFS was based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review and was defined as the time from randomization to radiological disease progression or death. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on or prior to the current assessment (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of greater than or equal to (≥) 5 mm.
Data for this outcome measure was not collected due to early termination of study.
Posted
From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)
ID
Title
Description
OG000
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG001
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
Secondary
Expansion Portion: Disease Control Rate (DCR) Based on RECIST v1.1: Percentage of Participants With CR, PR or Stable Disease (SD)
DCR was defined as the percentage of participants with CR, PR, or SD based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
Data for this outcome measure was not collected due to early termination of study.
Posted
From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)
ID
Title
Description
OG000
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG001
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
Secondary
Expansion Portion: Overall Survival (OS)
Overall survival was defined as the time from randomization until death from any cause.
This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module.
Posted
From randomization until death from any cause (maximum exposure: 421 days)
ID
Title
Description
OG000
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG001
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG002
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Secondary
Expansion Portion: OS by PD-L1 Expression Levels
Overall survival was defined as the time from randomization until death from any cause.
This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module.
Posted
From randomization until death from any cause (maximum exposure: 421 days)
ID
Title
Description
OG000
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG001
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG002
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Secondary
Expansion Portion: Number of Participants With AEs
An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Safety population included all participants who received any study medication.
Posted
Count of Participants
Participants
From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)
ID
Title
Description
OG000
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG001
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
Secondary
Expansion Portion: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters (Hematology and Blood Chemistry)
Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, WBC count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, BUN, albumin, total bilirubin, alkaline phosphatase, AST, ALT, electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Safety population included all participants who received any study medication.
Posted
Count of Participants
Participants
From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)
ID
Title
Description
OG000
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG001
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Secondary
Expansion Portion: Number of Participants With Clinically Significant Abnormalities in ECG and Vital Signs
Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Data for this outcome measure was not collected due to early termination of study.
Posted
From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)
ID
Title
Description
OG000
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG001
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
Secondary
Expansion Period: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication
Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Safety population included all participants who received any study medication.
Posted
Count of Participants
Participants
From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 421 days)
ID
Title
Description
OG000
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG001
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Secondary
Run-in and Expansion Portion : Maximum Observed Plasma Concentration (Cmax) of PEGPH20, ATEZO, GEM, and CIS
Plasma pharmacokinetic (PK) data were planned to be analyzed using a noncompartmental analysis approach.
Data for this outcome measure was not collected due to early termination of study.
Posted
PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and end of treatment (EOT) (maximum exposure: 508 days for run-in and 421 days for expansion); CIS and GEM: Cycle 1: multiple timepoints on Days 2,9
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
Secondary
Run-in and Expansion Portion : Minimum Observed Plasma Concentration (Cmin) of PEGPH20 and ATEZO
PK data were planned to be analyzed using a noncompartmental analysis approach.
Data for this outcome measure was not collected due to early termination of study.
Posted
PEGPH20 and ATEZO: Treatment Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15; ATEZO: Day 1 of subsequent cycles and EOT visit (7 days after last 21-day cycle) (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
Secondary
Run-in and Expansion Portion : Elimination Rate Constant (Kel) of PEGPH20
PK data were planned to be analyzed using a noncompartmental analysis approach.
Data for this outcome measure was not collected due to early termination of study.
Posted
Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
OG002
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
Secondary
Run-in and Expansion Portion : Terminal Elimination Plasma Half-life (t1/2) of PEGPH20, ATEZO, GEM, and CIS
PK data were planned to be analyzed using a noncompartmental analysis approach.
Data for this outcome measure was not collected due to early termination of study.
Posted
PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
Secondary
Run-in and Expansion Portion : Clearance (CL) of PEGPH20, ATEZO, GEM, and CIS
PK data were planned to be analyzed using a noncompartmental analysis approach.
Data for this outcome measure was not collected due to early termination of study.
Posted
PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
OG002
Secondary
Run-in and Expansion Portion : Volume of Distribution (Vd) of PEGPH20, ATEZO, GEM, and CIS
PK data were planned to be analyzed using a noncompartmental analysis approach.
Data for this outcome measure was not collected due to early termination of study.
Posted
PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
OG002
Secondary
Run-in and Expansion Portion: Area Under the Concentration Time Curve (AUC) of PEGPH20, ATEZO, GEM, and CIS
PK data were planned to be analyzed using a noncompartmental analysis approach.
Data for this outcome measure was not collected due to early termination of study.
Posted
PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
ID
Title
Description
OG000
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
OG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
Time Frame
From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Description
Safety population included all participants who received any study medication.
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
Run-in Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
7
9
6
9
9
9
EG001
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
3
9
2
9
9
9
EG002
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
10
24
11
24
24
24
EG003
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
13
22
16
22
22
22
EG004
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
0
11
7
11
10
11
EG005
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
6
10
4
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected9 at risk
EG0020 affected24 at risk
EG0031 affected22 at risk
EG0040 affected11 at risk
EG0050 affected10 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0012 affected9 at risk
EG0020 affected24 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Chills
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Portal hypertension
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Systemic immune activation
Immune system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Cholangitis infective
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Septic shock
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Renal vein thrombosis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Ovarian necrosis
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
This is a sex-specific adverse event that only affects female participants.
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0021 affected13 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Embolism
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0004 affected9 at risk
EG0016 affected9 at risk
EG00212 affected24 at risk
EG00315 affected22 at risk
EG0043 affected11 at risk
EG0058 affected10 at risk
Haemorrhagic anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected9 at risk
EG0011 affected9 at risk
EG0022 affected24 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected9 at risk
EG0012 affected9 at risk
EG0025 affected24 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0004 affected9 at risk
EG0012 affected9 at risk
EG0022 affected24 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Eye discharge
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Eye swelling
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Photopsia
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Visual impairment
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected9 at risk
EG0012 affected9 at risk
EG00210 affected24 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0004 affected9 at risk
EG0014 affected9 at risk
EG00210 affected24 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0012 affected9 at risk
EG0029 affected24 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0012 affected9 at risk
EG0021 affected24 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0023 affected24 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0005 affected9 at risk
EG0014 affected9 at risk
EG00218 affected24 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Sensitivity of teeth
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected9 at risk
EG0013 affected9 at risk
EG00212 affected24 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected9 at risk
EG0011 affected9 at risk
EG0022 affected24 at risk
EG003
Catheter site inflammation
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Catheter site pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Chest pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Chills
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0005 affected9 at risk
EG0018 affected9 at risk
EG00215 affected24 at risk
EG003
Feeling cold
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Generalised oedema
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Injection site bruising
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected9 at risk
EG0020 affected24 at risk
EG003
Injection site pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Localised oedema
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected9 at risk
EG0015 affected9 at risk
EG00210 affected24 at risk
EG003
Peripheral swelling
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0026 affected24 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Catheter site cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Cystitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Candida infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0023 affected24 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Febrile nonhaemolytic transfusion reaction
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Mouth injury
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Nail injury
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0012 affected9 at risk
EG0024 affected24 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0004 affected9 at risk
EG0012 affected9 at risk
EG0026 affected24 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0002 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Blood fibrinogen decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Blood pressure increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Blood sodium increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Granulocyte count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Grip strength decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Liver function test increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Monocyte count increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0014 affected9 at risk
EG0027 affected24 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0013 affected9 at risk
EG0025 affected24 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Transaminases increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Troponin I increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Weight decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Weight increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0025 affected24 at risk
EG003
White blood cell count increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0004 affected9 at risk
EG0014 affected9 at risk
EG0026 affected24 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0023 affected24 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected9 at risk
EG0029 affected24 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0025 affected24 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected9 at risk
EG0022 affected24 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Extremity contracture
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected9 at risk
EG0012 affected9 at risk
EG00211 affected24 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0022 affected24 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected9 at risk
EG0013 affected9 at risk
EG0028 affected24 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0012 affected9 at risk
EG0020 affected24 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Benign neoplasm of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0013 affected9 at risk
EG0023 affected24 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Migraine
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0022 affected24 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0022 affected24 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0025 affected24 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Tremor
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0024 affected24 at risk
EG003
Emotional distress
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0013 affected9 at risk
EG0025 affected24 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0021 affected13 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0026 affected24 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0024 affected24 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected9 at risk
EG0012 affected9 at risk
EG0024 affected24 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0021 affected24 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Prurit
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected9 at risk
EG0021 affected24 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0022 affected24 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected24 at risk
EG003
Embolism
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Flushing
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Haematoma
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Hot flush
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0021 affected24 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected9 at risk
EG0023 affected24 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected24 at risk
EG003
The study was terminated prematurely by the Sponsor due to stopping the clinical development of PEGPH20 in all indications based on negative pivotal data in metastatic pancreatic cancer.
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
Units
Counts
Participants
OG0009
OG0019
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
Units
Counts
Participants
OG0009
OG0019
Title
Denominators
Categories
Title
Measurements
OG0006
OG0017
OG002
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG003
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Units
Counts
Participants
OG0000
OG0010
OG002
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG003
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG002
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG003
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG002
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG003
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG003
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG003
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG002
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG003
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG00024
OG00122
OG00211
OG00310
Title
Denominators
Categories
Title
Measurements
OG00024
OG00122
OG00210
OG00310
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG002
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG003
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG00024
OG00122
OG00211
OG00310
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG002
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG003
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG002
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG003
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG00024
OG00122
OG00211
OG00310
Title
Denominators
Categories
Title
Measurements
OG00016
OG00121
OG0024
OG0037
OG002
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG003
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG004
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG005
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG003
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG004
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG005
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG003
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG004
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG005
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG003
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG004
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG005
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG003
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG004
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG005
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG003
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG004
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG005
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
OG003
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
OG004
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
OG005
Expansion Portion: CISGEM
Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).