A Study Assessing Pamiparib With Radiation and/or Temozol... | NCT03150862 | Trialant
NCT03150862
Sponsor
BeiGene USA, Inc.
Status
Completed
Last Update Posted
Feb 4, 2025Actual
Enrollment
116Actual
Phase
Phase 1Phase 2
Conditions
Brain and Central Nervous System Tumors
Interventions
Pamiparib
TMZ
Radiation
Countries
United States
Australia
France
Netherlands
Switzerland
Protocol Section
Identification Module
NCT ID
NCT03150862
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BGB-290-104
Secondary IDs
ID
Type
Description
Link
2017-001554-33
EudraCT Number
Brief Title
A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma
Official Title
A Phase 1b/2 Study to Assess the Safety, Tolerability and Efficacy of BGB-290 in Combination With Radiation Therapy (RT) and/or Temozolomide (TMZ) in Subjects With First-line or Recurrent/Refractory Glioblastoma
Acronym
Not provided
Organization
BeiGeneINDUSTRY
Status Module
Record Verification Date
May 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 24, 2017Actual
Primary Completion Date
Mar 17, 2021Actual
Completion Date
Mar 17, 2021Actual
First Submitted Date
May 8, 2017
First Submission Date that Met QC Criteria
May 10, 2017
First Posted Date
May 12, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Mar 3, 2022
Results First Submitted that Met QC Criteria
May 11, 2022
Results First Posted Date
May 31, 2022Actual
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
Feb 2, 2025
Last Update Posted Date
Feb 4, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BeiGene USA, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 primary objective of this study is to evaluate the safety, efficacy and clinical activity of Pamiparib in combination with radiation therapy (RT) and/or temozolomide (TMZ) in participants with newly diagnosed or recurrent/refractory glioblastoma.
Detailed Description
An open-label, multiple-dose, dose-escalation study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of Pamiparib in combination with radiation therapy (RT) and/or TMZ.
In dose escalation/Phase 1b, Pamiparib will be combined with RT (Arm A) or RT and TMZ (Arm B) in participants with newly diagnosed unmethylated glioblastoma (GBM) and in Arm C of the study Pamiparib will be combined with TMZ in participants with methylated or unmethylated recurrent/refractory GBM.
The dose expansion/Phase 2 phase will enroll up to 4 cohorts: participants with newly diagnosed unmethylated GBM in Arms A and B, and 2 cohorts of participants with recurrent/refractory GBM grouped by O-6-methylguanine-DNA methyltransferase (MGMT) status - unmethylated or methylated - in Arm C.
Participants in Arms A and B are treated until completion of RT and participants in Arm C may continue treatment in the absence of safety concerns and disease progression.
neoplasms, central nervous system neoplasms, neoplasms by histologic type, neoplasms by site
astrocytoma
neuroepithelial
neuroectodermal tumors
germ cell and embryonal
antineoplastic agents
glandular and epithelial
nerve tissue, nervous system diseases
temozolomide
BGB-290
alkylating, alkylating agents
molecular mechanisms of pharmacological action
Poly(ADP-ribose) polymerase inhibitors
enzyme inhibitors
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
116Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A (Dose Escalation)
Experimental
Participants with newly diagnosed unmethylated GBM will receive Pamiparib and radiation therapy.
Drug: Pamiparib
Radiation: Radiation
Arm B (Dose Escalation)
Experimental
Participants with newly diagnosed unmethylated GBM will receive Pamiparib, radiation therapy (RT) and temozolomide (TMZ).
Drug: Pamiparib
Drug: TMZ
Radiation: Radiation
Arm A (Dose Expansion)
Experimental
Participants with newly diagnosed unmethylated GBM will receive Pamiparib and radiation therapy.
Drug: Pamiparib
Radiation: Radiation
Arm C (Dose Escalation)
Experimental
Participants with recurrent/refractory methylated or unmethylated GBM will receive Pamiparib and TMZ.
Drug: Pamiparib
Drug: TMZ
Arm C (Dose Expansion-Cohorts C1 and C2)
Experimental
Participants with recurrent/refractory methylated or unmethylated GBM will receive Pamiparib and TMZ.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pamiparib
Drug
Administered as specified in the treatment arm
Arm A (Dose Escalation)
Arm A (Dose Expansion)
Arm B (Dose Escalation)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1b Escalation Phase: Number of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by CTCAE
A DLT is defined as one of the following toxicities occurring during the DLT assessment window:
Grade ≥3 non-hematologic, non-hepatic major organ adverse event (AE) Grade 4 neutropenia lasting >7 days Grade ≥3 febrile neutropenia Grade 3 thrombocytopenia with clinically significant bleeding Grade 4 thrombocytopenia lasting > 3 days and requiring transfusion, or any decreased platelet count <15,000/mm3/ <15.0 x 109/L Grade ≥4 anemia Grade ≥3 total bilirubin or hepatic transaminases (ALT or AST)
Arm A:Day 1 Pamiparib dose until 4 weeks after the last RT; Arm B: Day 1 of Pamiparib and Temozolomide until 4 weeks after the last RT; Arm C: 1st cycle of 28 days
Phase 1b Escalation Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as Assessed by CTCAE
A treatment-emergent adverse event (TEAE) is defined as an AE that had an onset date on or after first dose of study treatment or was worsening in severity from baseline (pretreatment) up to 30 days following permanent study treatment discontinuation or initiation of new anti-cancer therapy, whichever occurs first.
An SAE is any untoward medical occurrence that, at any dose meets at least one of the following criteria: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is considered a significant medical AE based on medical judgment.
From initiation of study treatment (for TEAE) or from the date informed consent has been signed (for SAE), until 30 days after last study treatment or initiation of new anticancer therapy, whichever occurs first (up to 3 years and 7.5 months)
Phase 1b Escalation Phase Arm C: Number of Participants With Clinically Relevant Changes in Vital Signs and Clinical Laboratory Measurements
From the date of first dose up to end of study (EOS) visit (up to 3 years and 7.5 months)
Phase 2 Arm A: Modified Disease Control Rate (DCR) as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria
Secondary Outcomes
Measure
Description
Time Frame
Phase 1B and Phase 2: Pharmacokinetics: Ctrough of Pamiparib
Pre-dose, 2 hours post dose on Days 1 and 15 of radiation Therapy
Phase 1b Arm A and Arm B Escalation Phase: Modified Disease Control Rate as Assessed by RANO Criteria
Modified DCR is defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) per RANO criteria as the response assessment at the end-of-treatment (EOT) visit.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria: All participants
Age ≥ 18 years old.
Confirmed diagnosis of glioblastoma (WHO Grade IV).
Agreement to provide archival tumor tissue for exploratory biomarker analysis
Ability to undergo serial MRIs.
Eastern Cooperative Oncology Group (ECOG) status ≤ 1.
Adequate hematologic and end-organ function
Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last dosing.
Ability to swallow whole capsules.
Participants in Arms A and B (not Arm C) must meet inclusion criteria # 9 - 11:
No previous treatment for GBM except surgery.
Able to start radiation therapy ≤ 49 days after surgery but ≥ 14 days after a biopsy or ≥28 days after an open biopsy or craniotomy with adequate wound healing.
Documented unmethylated MGMT promoter status.
Participants in Arm C Escalation (Phase 1b) must meet inclusion criteria # 12 - 15:
Documentation of MGMT promoter status
No prior systemic chemotherapy other than TMZ for GBM.
Histologically confirmed secondary glioblastoma
Disease that is evaluable or measurable as defined by Response Assessment in Neuro-Oncology (RANO) criteria
Participants in Arm C Expansion (Phase 2), must meet criteria # 16 - 18:
Histologically confirmed de novo (primary) glioblastoma with unequivocal first progressive disease (PD) after RT with concurrent/adjuvant TMZ chemotherapy
Disease that is measurable as defined by RANO criteria
Documentation of MGMT promoter status
Key Exclusion Criteria: All participants
Prior chemotherapy, biologic therapy, immunotherapy or investigational agents ≤21 days prior to start of study treatment.
Toxicity of ≥ Grade 2 from prior therapy.
Major surgery or significant other injury ≤ 4 weeks prior to start of study treatment.
History of other active malignancies within 2 years with exception of (i) adequately treated in situ cancer of the cervix, (ii) non-melanoma skin cancer, or (iii) localized adequately treated cancer with curative intent or malignancy diagnosed > 2 years ago with no evidence of disease and no treatment ≤ 2 years prior to study treatment.
Active infection requiring systemic treatment.
Known human immunodeficiency virus (HIV) or active viral hepatitis.
Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease, ventricular arrhythmia or Cerebrovascular Accident (CVA) ≤ 6 months prior to start of treatment.
Active clinically significant gastrointestinal disease.
Active bleeding disorder ≤ 6 months prior to start of treatment.
Need for therapeutic anti-coagulation with heparin, warfarin or other anticoagulants.
Use of any medications or food known to be strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong inducers.
Pregnant or nursing females.
Significant intercurrent illness that may result in participant's death prior to death from glioblastoma.
Arms B and C Only:
Known hypersensitivity to any component of TMZ or decarbazine (DTIC).
Have hereditary problems of galactose intolerance
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Xiong Y, Guo Y, Liu Y, Wang H, Gong W, Liu Y, Wang X, Gao Y, Yu F, Su D, Wang F, Zhu Y, Zhao Y, Wu Y, Qin Z, Sun X, Ren B, Jiang B, Jin W, Shen Z, Tang Z, Song X, Wang L, Liu X, Zhou C, Jiang B. Pamiparib is a potent and selective PARP inhibitor with unique potential for the treatment of brain tumor. Neoplasia. 2020 Sep;22(9):431-440. doi: 10.1016/j.neo.2020.06.009. Epub 2020 Jul 8.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
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
Not provided
Recruitment Details
This study consisted of a dose escalation phase and a dose expansion phase. A total of 116 participants were recruited in Netherlands, Switzerland and United States.
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 milligrams (mg) pamiparib orally twice daily (BID) for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
3
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 23, 2018
Mar 3, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel 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
No Masking
Who Masked
Not provided
Drug: Pamiparib
Drug: TMZ
Arm C (Dose Escalation)
Arm C (Dose Expansion-Cohorts C1 and C2)
BGB-290
TMZ
Drug
Administered as specified in the treatment arm
Arm B (Dose Escalation)
Arm C (Dose Escalation)
Arm C (Dose Expansion-Cohorts C1 and C2)
Radiation
Radiation
Up to 60 Gy (total) over 6 - 7 weeks
Arm A (Dose Escalation)
Arm A (Dose Expansion)
Arm B (Dose Escalation)
Modified DCR is defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) per RANO criteria as the response assessment at the end-of-treatment (EOT) visit.
From the date of first dose up to first documentation of disease progression while participant is alive ( up to 3 years and 7.5 months)
Phase 2 Arm C: Objective Response Rate (ORR) as Assessed Using RANO Criteria
ORR (objective response rate) is defined as percentage of participants with best overall response of CR or PR per RANO criteria (confirmed by a subsequent tumor assessment at least four weeks apart).
From the date of first dose up to first documentation of disease progression while participant is alive (up to 3 years and 7.5 months)
Phase 1b Arm C: Number of Cycles of Treatment Received by Participants
Data shows the number of participants who received treatment for the given number of cycles.
From the date of first dose up to EOS visit ( up to 3 years and 7.5 months)
Phase 1b Arm C: Average Dose Intensity of Pamiparib And TMZ Received Per Participant
The average dose intensity per participant = total dose (mg) per participant / duration of treatment (days).
From the date of first dose until EOS visit (up to 3 years and 7.5 months)
From the date of first dose up to first documentation of disease progression while participant is alive (approximately 3 years and 7.5 months)
Phase 1b Escalation Phase Arm C: Disease Control Rate as Assessed by RANO Criteria
DCR is defined as the percentage of participants with best overall response of CR, PR or SD per RANO criteria. CR or PR will be confirmed by a subsequent tumor assessment at least four weeks apart
From the date of first dose up to first documentation of disease progression while participant is alive (up to 3 years and 7.5 months)
Phase 1b and Phase 2 Arms A and B: ORR as Assessed Using RANO Criteria
ORR is defined as percentage of participants with best overall response of CR or PR per RANO criteria (confirmed by a subsequent tumor assessment at least four weeks apart).
From the date of first dose up to first documentation of disease progression while participant is alive ( up to 3 years and 7.5 months)
Phase 1b and Phase 2 Arms A, B and C: Clinical Benefit Rate as Assessed Using RANO Criteria
Clinical benefit rate (CBR) is defined as the percentage of participants with best overall response of CR, PR or SD ≥ 24 weeks per RANO criteria (confirmed by a subsequent tumor assessment at least four weeks apart).
From the date of first dose up to first documentation of disease progression while participant is alive (up to 3 years and 7.5 months)
Phase 1b and Phase 2 Arms A, B and C: Duration of Response (DOR) as Assessed Using RANO Criteria
DOR is defined as the time from the date of the earliest documented response to disease progression or death for any cause whichever occurs earlier (confirmed by a subsequent tumor assessment at least four weeks apart).
From first documentation of CR or PR to first documentation of disease progression or death (up to 3 years and 7.5 months)
Phase 1b and Phase 2 Arms A, B and C: Progression Free Survival (PFS) as Assessed Using RANO Criteria
PFS is defined as the time from the first dose date to disease progression per RANO criteria or death, whichever occurs first.
From the date of first dose up to first documentation of disease progression or death (up to 3 years and 7.5 months)
Phase 1b and Phase 2 Arms A, B and C: Overall Survival (OS)
OS is defined as the time from the first dose date to date of death for any cause.
From the date of first dose up to the date of death (up to 3 years and 7.5 months)
Phase 2 Arms A and C Expansion Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A treatment-emergent adverse event (TEAE) is defined as an AE that had an onset date on or after first dose of study treatment or was worsening in severity from baseline (pretreatment) up to 30 days following permanent study treatment discontinuation or initiation of new anti-cancer therapy, whichever occurs first. An SAE is any untoward medical occurrence that, at any dose meets at least one of the following criteria: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is considered a significant medical AE based on medical judgment.
From initiation of study treatment (for TEAE) or from the date informed consent has been signed (for SAE), until 30 days after last study treatment or initiation of new anticancer therapy, whichever occurs first (up to 3 years and 7.5 months)
Phase 2 Expansion Phase Arm A and C: Number of Participants With Clinically Relevant Changes in Vital Signs and Clinical Laboratory Measurements
From the date of first dose up to EOS visit (up to 3 years and 7.5 months)
Phase 2 Arms A and C Expansion Phase: Number of Cycles of Treatment Received by Participants
Data shows the number of participants who received treatment for the given number of cycles.
From date of first dose up to EOS Visit (up to 3 years and 7.5 months)
Phase 2 Arms A and C Expansion Phase: Average Dose Intensity of Pamiparib and TMZ Received Per Participant
The average dose intensity per participant = total dose (mg) per participant / duration of treatment (days).
From date of first dose up to EOS Visit (up to 3 years and 7.5 months)
Los Angeles
California
90095
United States
University of California At San Francisco
San Francisco
California
94143
United States
Sarah Cannon Research Institute (Scri) At Health One
Denver
Colorado
80219
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
Henry Ford Hospital
Detroit
Michigan
48202
United States
Midamerica Division, Inc
Kansas City
Missouri
64132
United States
Washington University in St Louis
St Louis
Missouri
63110
United States
Memorial Sloan Kettering Cancer Center Mskcc
New York
New York
10065
United States
Cleveland Clinic Foundation
Cleveland
Ohio
44195
United States
Ohio State University
Columbus
Ohio
43210
United States
Sarah Cannon Research Institute (Scri) Stephenson Cancer Center
Oklahoma City
Oklahoma
73104
United States
Penn State Milton S Hershey Medical Center
Hershey
Pennsylvania
17033
United States
Thomas Jefferson University Hospital Jefferson Health
Philadelphia
Pennsylvania
19107
United States
Tennessee Oncology, Pllc Nashville
Nashville
Tennessee
37203
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
University of Virginia
Charlottesville
Virginia
22903
United States
Liverpool Hospital
Liverpool
New South Wales
2170
Australia
Institut Gustave Roussy
Villejuif
94805
France
Universitair Medisch Centrum Utrecht
Utrecht
3584 CX
Netherlands
University of Zurich Medical School
Zurich
8032
Switzerland
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
FG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
FG005
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
FG006
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
FG007
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
FG0003 subjects
FG0018 subjects
FG0029 subjects
FG00340 subjects
FG0049 subjects
FG0059 subjects
FG0068 subjects
FG00730 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0003 subjects
FG0018 subjects
FG0029 subjects
FG00340 subjects
FG0049 subjects
FG0059 subjects
FG0068 subjects
FG00730 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0017 subjects
FG0028 subjects
FG00327 subjects
FG0044 subjects
FG0058 subjects
FG0066 subjects
FG00721 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Sponsor's decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00310 subjects
FG004
Change in Methylation status
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Roll over in to Long Term Extension
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Safety Analysis Set includes all participants who received any study treatment (pamiparib, RT, and/or TMZ). The Safety Analysis Set was used for all efficacy and safety analyses.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
BG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
BG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
BG005
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
BG006
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
BG007
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0018
BG0029
BG00340
BG0049
BG0059
BG0068
BG00730
BG008116
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.7± 8.39
BG00163.4± 8.80
BG00258.8± 7.66
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1b Escalation Phase: Number of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by CTCAE
A DLT is defined as one of the following toxicities occurring during the DLT assessment window:
Grade ≥3 non-hematologic, non-hepatic major organ adverse event (AE) Grade 4 neutropenia lasting >7 days Grade ≥3 febrile neutropenia Grade 3 thrombocytopenia with clinically significant bleeding Grade 4 thrombocytopenia lasting > 3 days and requiring transfusion, or any decreased platelet count <15,000/mm3/ <15.0 x 109/L Grade ≥4 anemia Grade ≥3 total bilirubin or hepatic transaminases (ALT or AST)
Safety Analysis Set
Posted
Number
participants
Arm A:Day 1 Pamiparib dose until 4 weeks after the last RT; Arm B: Day 1 of Pamiparib and Temozolomide until 4 weeks after the last RT; Arm C: 1st cycle of 28 days
ID
Title
Description
OG000
Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
OG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
OG004
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG005
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
Units
Counts
Participants
OG0003
OG0018
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG003
Primary
Phase 1b Escalation Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as Assessed by CTCAE
A treatment-emergent adverse event (TEAE) is defined as an AE that had an onset date on or after first dose of study treatment or was worsening in severity from baseline (pretreatment) up to 30 days following permanent study treatment discontinuation or initiation of new anti-cancer therapy, whichever occurs first.
An SAE is any untoward medical occurrence that, at any dose meets at least one of the following criteria: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is considered a significant medical AE based on medical judgment.
Safety Analysis Set
Posted
Number
participants
From initiation of study treatment (for TEAE) or from the date informed consent has been signed (for SAE), until 30 days after last study treatment or initiation of new anticancer therapy, whichever occurs first (up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
Primary
Phase 1b Escalation Phase Arm C: Number of Participants With Clinically Relevant Changes in Vital Signs and Clinical Laboratory Measurements
Safety Analysis Set
Posted
Number
Number of participants
From the date of first dose up to end of study (EOS) visit (up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG001
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
Units
Counts
Participants
OG000
Primary
Phase 2 Arm A: Modified Disease Control Rate (DCR) as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria
Modified DCR is defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) per RANO criteria as the response assessment at the end-of-treatment (EOT) visit.
The Efficacy Analysis Set (Arm A) includes participants in the Safety Analysis Set who had a tumor assessment at baseline and at End of Treatment unless discontinued treatment or study early due to disease progression or death prior to tumor assessment. Participants with available data were included in the analysis.
Posted
Number
95% Confidence Interval
Percentage of participants
From the date of first dose up to first documentation of disease progression while participant is alive ( up to 3 years and 7.5 months)
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Units
Counts
Participants
OG000
Primary
Phase 2 Arm C: Objective Response Rate (ORR) as Assessed Using RANO Criteria
ORR (objective response rate) is defined as percentage of participants with best overall response of CR or PR per RANO criteria (confirmed by a subsequent tumor assessment at least four weeks apart).
The Efficacy Analysis Set (Arm C) includes participants in the Safety Analysis Set who had measurable disease at baseline and at least one postbaseline tumor assessment unless discontinued treatment or study early due to disease progression or death prior to tumor assessment. Participants with available data were included in the analysis.
Posted
Number
95% Confidence Interval
Percentage of participants
From the date of first dose up to first documentation of disease progression while participant is alive (up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
Units
Counts
Participants
OG000
Primary
Phase 1b Arm C: Number of Cycles of Treatment Received by Participants
Data shows the number of participants who received treatment for the given number of cycles.
Safety Analysis Set
Posted
Number
participants
From the date of first dose up to EOS visit ( up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG001
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
Units
Counts
Participants
OG000
Primary
Phase 1b Arm C: Average Dose Intensity of Pamiparib And TMZ Received Per Participant
The average dose intensity per participant = total dose (mg) per participant / duration of treatment (days).
Safety Analysis Set
Posted
Mean
Standard Deviation
milligrams/Day
From the date of first dose until EOS visit (up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG001
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
Units
Counts
Participants
OG000
Secondary
Phase 1B and Phase 2: Pharmacokinetics: Ctrough of Pamiparib
The Pharmacokinetic (PK) Analysis Set includes all participants for whom valid pamiparib PK parameters can be estimated. Participants with available data were included in the analysis.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose, 2 hours post dose on Days 1 and 15 of radiation Therapy
ID
Title
Description
OG000
Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
OG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Phase 1b Arm A and Arm B Escalation Phase: Modified Disease Control Rate as Assessed by RANO Criteria
Modified DCR is defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) per RANO criteria as the response assessment at the end-of-treatment (EOT) visit.
Efficacy Analysis Set; Participants with available data were included in the analysis
Posted
Number
95% Confidence Interval
Percentage of participants
From the date of first dose up to first documentation of disease progression while participant is alive (approximately 3 years and 7.5 months)
ID
Title
Description
OG000
Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
OG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Secondary
Phase 1b Escalation Phase Arm C: Disease Control Rate as Assessed by RANO Criteria
DCR is defined as the percentage of participants with best overall response of CR, PR or SD per RANO criteria. CR or PR will be confirmed by a subsequent tumor assessment at least four weeks apart
Efficacy Analysis Set; Participants with available data were included in the analysis.
Posted
Number
95% Confidence Interval
Percentage of participants
From the date of first dose up to first documentation of disease progression while participant is alive (up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm C: DE- Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG001
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
Units
Counts
Participants
Secondary
Phase 1b and Phase 2 Arms A and B: ORR as Assessed Using RANO Criteria
ORR is defined as percentage of participants with best overall response of CR or PR per RANO criteria (confirmed by a subsequent tumor assessment at least four weeks apart).
Efficacy Evaluable Analysis Set; Participants with available data were included in the analysis.
Posted
Number
95% Confidence Interval
Percentage of participants
From the date of first dose up to first documentation of disease progression while participant is alive ( up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
OG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Secondary
Phase 1b and Phase 2 Arms A, B and C: Clinical Benefit Rate as Assessed Using RANO Criteria
Clinical benefit rate (CBR) is defined as the percentage of participants with best overall response of CR, PR or SD ≥ 24 weeks per RANO criteria (confirmed by a subsequent tumor assessment at least four weeks apart).
Efficacy Analysis Set; participants with available data were included in the analysis
Posted
Number
95% Confidence Interval
Percentage of participants
From the date of first dose up to first documentation of disease progression while participant is alive (up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
OG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Secondary
Phase 1b and Phase 2 Arms A, B and C: Duration of Response (DOR) as Assessed Using RANO Criteria
DOR is defined as the time from the date of the earliest documented response to disease progression or death for any cause whichever occurs earlier (confirmed by a subsequent tumor assessment at least four weeks apart).
Efficacy Analysis Set; Only the participants with objective responses were included in DOR analysis.
Posted
Median
95% Confidence Interval
Months
From first documentation of CR or PR to first documentation of disease progression or death (up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
OG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Secondary
Phase 1b and Phase 2 Arms A, B and C: Progression Free Survival (PFS) as Assessed Using RANO Criteria
PFS is defined as the time from the first dose date to disease progression per RANO criteria or death, whichever occurs first.
Safety Analysis Set
Posted
Median
95% Confidence Interval
Months
From the date of first dose up to first documentation of disease progression or death (up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
OG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
OG003
Secondary
Phase 1b and Phase 2 Arms A, B and C: Overall Survival (OS)
OS is defined as the time from the first dose date to date of death for any cause.
Safety Analysis Set
Posted
Median
95% Confidence Interval
Months
From the date of first dose up to the date of death (up to 3 years and 7.5 months)
ID
Title
Description
OG000
Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
OG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Phase 2 Arms A and C Expansion Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A treatment-emergent adverse event (TEAE) is defined as an AE that had an onset date on or after first dose of study treatment or was worsening in severity from baseline (pretreatment) up to 30 days following permanent study treatment discontinuation or initiation of new anti-cancer therapy, whichever occurs first. An SAE is any untoward medical occurrence that, at any dose meets at least one of the following criteria: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is considered a significant medical AE based on medical judgment.
Safety Analysis Set
Posted
Number
Number of participants
From initiation of study treatment (for TEAE) or from the date informed consent has been signed (for SAE), until 30 days after last study treatment or initiation of new anticancer therapy, whichever occurs first (up to 3 years and 7.5 months)
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
Secondary
Phase 2 Expansion Phase Arm A and C: Number of Participants With Clinically Relevant Changes in Vital Signs and Clinical Laboratory Measurements
Safety Analysis Set
Posted
Number
Number of participants
From the date of first dose up to EOS visit (up to 3 years and 7.5 months)
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
Units
Counts
Participants
OG000
Secondary
Phase 2 Arms A and C Expansion Phase: Number of Cycles of Treatment Received by Participants
Data shows the number of participants who received treatment for the given number of cycles.
Safety Analysis Set; For Arm A Only participants who entered the maintenance phase were included in the analysis as per protocol.
Posted
Number
participants
From date of first dose up to EOS Visit (up to 3 years and 7.5 months)
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
Units
Counts
Participants
OG000
Secondary
Phase 2 Arms A and C Expansion Phase: Average Dose Intensity of Pamiparib and TMZ Received Per Participant
The average dose intensity per participant = total dose (mg) per participant / duration of treatment (days).
Safety Analysis Set
Posted
Mean
Standard Deviation
Milligrams/Day
From date of first dose up to EOS Visit (up to 3 years and 7.5 months)
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
OG001
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
Units
Counts
Participants
OG000
Time Frame
From initiation of study treatment (for TEAE) or from the date informed consent has been signed (for SAE), until 30 days after last study treatment or initiation of new anticancer therapy, whichever occurs first (up to 3 years and 7.5 months)
Description
A treatment-emergent adverse event (TEAE) is defined as an AE that had an onset date on or after first dose of study treatment or was worsening in severity from baseline (pretreatment) up to 30 days following permanent study treatment discontinuation or initiation of new anti-cancer therapy, whichever occurs first.
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
Arm 1Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks
Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
2
3
0
3
3
3
EG001
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
7
8
2
8
8
8
EG002
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
4
9
2
9
9
9
EG005
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
8
9
4
9
9
9
EG006
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
6
8
3
8
7
8
EG007
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
21
30
11
30
29
30
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG0032 events2 affected40 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected30 at risk
Febrile neutropenia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Atrial fibrillation
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Vertigo
Ear and labyrinth disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Anal incontinence
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Asthenia
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Chills
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Fatigue
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Gait disturbance
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Impaired healing
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pyrexia
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Bronchitis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonia
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Sepsis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Wound infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Subarachnoid haematoma
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Tumour flare
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Aphasia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Apraxia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Brain oedema
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Cerebral cyst
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Cerebrovascular accident
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Depressed level of consciousness
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dysaesthesia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dysarthria
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hemiparesis
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hemiplegia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hydrocephalus
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Nervous system disorder
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Partial seizures
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Psychogenic seizure
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Seizure
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Syncope
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Agitation
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Confusional state
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Mental status changes
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Suicide attempt
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Embolism
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Haematoma
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hypotension
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG00319 events13 affected40 at risk
EG0047 events4 affected9 at risk
EG0053 events3 affected9 at risk
EG0066 events3 affected8 at risk
EG00715 events6 affected30 at risk
Increased tendency to bruise
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Angina pectoris
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Bradycardia
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Sinus tachycardia
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Tachycardia
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Ear congestion
Ear and labyrinth disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Ear pain
Ear and labyrinth disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Tinnitus
Ear and labyrinth disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Vertigo
Ear and labyrinth disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0022 events1 affected9 at risk
EG003
Dry eye
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Erythema of eyelid
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Lacrimation increased
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Photophobia
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Vision blurred
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Visual impairment
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Abdominal distension
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Breath odour
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Colitis
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0023 events3 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dry mouth
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Dysphagia
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Eructation
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Femoral hernia
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Flatulence
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Haematemesis
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hyperaesthesia teeth
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Melaena
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events3 affected8 at risk
EG0025 events5 affected9 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Retching
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Tooth discolouration
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected9 at risk
EG003
Vomiting projectile
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Asthenia
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Chest pain
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Chills
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Early satiety
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Fatigue
General disorders
meddra 23.0
Systematic Assessment
EG0003 events3 affected3 at risk
EG0012 events2 affected8 at risk
EG0027 events6 affected9 at risk
EG003
Feeling cold
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Gait disturbance
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Influenza like illness
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Malaise
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Oedema peripheral
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pyrexia
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Swelling face
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Vessel puncture site pain
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hepatic lesion
Hepatobiliary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Cellulitis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Eye infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hordeolum
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Influenza
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Oral candidiasis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Oral herpes
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Osteomyelitis chronic
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Otitis media
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonia
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Postoperative wound infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Sinusitis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Tooth infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Wound infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Contusion
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pseudomeningocele
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Radiation injury
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Blood bilirubin increased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Blood bilirubin unconjugated increased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Blood creatinine increased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Cortisol decreased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Electrocardiogram QT prolonged
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Lymphocyte count decreased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Neutrophil count decreased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Platelet count decreased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Weight decreased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
White blood cell count decreased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected8 at risk
EG0023 events3 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Renal hamartoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Ageusia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Amnesia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Aphasia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0023 events3 affected9 at risk
EG003
Ataxia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Balance disorder
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected9 at risk
EG003
Brain oedema
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Cerebrospinal fluid leakage
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Cognitive disorder
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Disturbance in attention
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dizziness
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Drooling
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dysaesthesia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dysarthria
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dyslexia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Encephalopathy
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Epilepsy
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Facial paralysis
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Facial paresis
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Headache
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected8 at risk
EG0024 events4 affected9 at risk
EG003
Hemianopia homonymous
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Hemiparesis
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Hypersomnia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hypoaesthesia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Memory impairment
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Muscle spasticity
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Myoclonus
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Partial seizures
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Seizure
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Somnolence
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Taste disorder
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Tremor
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0022 events1 affected9 at risk
EG003
Visual field defect
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Agitation
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Alcohol abuse
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Anxiety
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Confusional state
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Decreased interest
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Depression
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Insomnia
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Irritability
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Persistent depressive disorder
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Suicidal ideation
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pollakiuria
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Polyuria
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Urinary incontinence
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0012 events2 affected8 at risk
EG0022 events2 affected9 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Skin atrophy
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Hypertension
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected9 at risk
EG003
Hypotension
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Pallor
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected9 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
OG004
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG005
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
Units
Counts
Participants
OG0003
OG0018
OG0029
OG0039
OG0049
OG0058
Title
Denominators
Categories
Participants with At Least 1 TEAE
Title
Measurements
OG0003
OG0018
OG0029
OG0039
OG0049
OG0058
TEAE with Grade 3 or Higher
Title
Measurements
OG0001
OG0013
OG0024
OG003
Treatment Emergent SAEs
Title
Measurements
OG0000
OG0012
OG0022
OG003
TEAE Leading to Death
Title
Measurements
OG0000
OG0010
OG0020
OG003
9
OG0018
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
32
Title
Denominators
Categories
Title
Measurements
OG00065.6(46.8 to 81.4)
28
Title
Denominators
Categories
Title
Measurements
OG00010.7(2.3 to 28.2)
9
OG0018
Title
Denominators
Categories
<1 cycle
Title
Measurements
OG0002
OG0013
1 cycle
Title
Measurements
OG0004
OG0010
2 cycles
Title
Measurements
OG0001
OG0012
3 cycles
Title
Measurements
OG0000
OG0011
4 cycles
Title
Measurements
OG0001
OG0010
5 cycles
Title
Measurements
OG0001
OG0010
6 cycles
Title
Measurements
OG0000
OG0010
7 cycles
Title
Measurements
OG0000
OG0010
>7 cycles
Title
Measurements
OG0000
OG0012
9
OG0018
Title
Denominators
Categories
Pamiparib
Title
Measurements
OG00097.5± 25.41
OG001107.6± 14.65
TMZ
Title
Measurements
OG00013.6± 1.88
OG00128.2± 10.80
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
OG005
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG006
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
OG007
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
OG005
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG006
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
OG007
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
OG005
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG006
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
OG007
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0031
OG0040
OG0050
OG0061
OG0073
Title
Denominators
Categories
Title
Measurements
OG0016.44(NA to NA)NA = NE; Not estimable due to insufficient number of events
OG00310.32(NA to NA)NA = NE; Not estimable due to insufficient number of events
OG00611.7(NA to NA)NA = NE; Not estimable due to insufficient number of events
OG007NA(12.68 to NA)NA = NE; Not estimable due to insufficient number of events
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
OG005
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG006
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
OG007
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
Units
Counts
Participants
OG0003
OG0018
OG0029
OG00340
OG0048
OG0059
OG0068
OG00730
Title
Denominators
Categories
Title
Measurements
OG0003.12(2.79 to 3.29)
OG0018.94(3.78 to 11.56)
OG0022.56(2.14 to NA)NA = NE; Not estimable to due to insufficient number of events
OG0034.44(3.29 to 6.24)
OG0045.75(2.37 to 6.47)
OG0051.81(0.82 to 3.48)
OG0062.66(0.66 to 7.39)
OG0071.87(1.48 to 1.91)
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
OG005
Arm C: DE - Pamiparib + Temozolomide 20 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
OG006
Arm C: DE - Pamiparib + Temozolomide 40 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
OG007
Arm C: E- Pamiparib + Temozolomide 60 mg
Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
Units
Counts
Participants
OG0003
OG0018
OG0029
OG00340
OG0048
OG0059
OG0068
OG00730
Title
Denominators
Categories
Title
Measurements
OG00014.46(13.93 to 14.98)
OG00113.44(4.14 to 20.24)
OG00210.25(4.44 to 19.84)
OG00312.71(9.79 to 14.46)
OG00414.23(7.98 to NA)NA = NE; Not estimable due to insufficient number of events
OG0056.00(2.60 to 9.79)
OG0068.62(2.96 to NA)NA = NE; Not estimable due to insufficient number of events
OG0077.79(6.21 to 10.68)
Units
Counts
Participants
OG00040
OG00130
Title
Denominators
Categories
Participants with at Lease 1 TEAE
Title
Measurements
OG00040
OG00129
TEAE with Grade 3 or Higher
Title
Measurements
OG00025
OG00119
Treatment Emergent SAEs
Title
Measurements
OG00018
OG00111
TEAE Leading to Death
Title
Measurements
OG0003
OG0011
40
OG00130
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
29
OG00130
Title
Denominators
Categories
<1 cycle
Title
Measurements
OG0003
OG0018
1 cycle
Title
Measurements
OG0009
OG0018
2 cycles
Title
Measurements
OG0002
OG0017
3 cycles
Title
Measurements
OG0002
OG0011
4 cycles
Title
Measurements
OG0003
OG0011
5 cycles
Title
Measurements
OG0003
OG0010
6 cycles
Title
Measurements
OG0003
OG0010
7 cycles
Title
Measurements
OG0000.0
OG0010
>7 cycles
Title
Measurements
OG0004
OG0015
40
OG00130
Title
Denominators
Categories
Pamiparib
Title
Measurements
OG000109.0± 22.07
OG001109.5± 15.22
TMZ
Title
Measurements
OG000NA± NANA = Not applicable since no TMZ was administered in this arm