Study of Talazoparib, a PARP Inhibitor, in Patients With... | NCT01286987 | Trialant
NCT01286987
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jan 10, 2019Actual
Enrollment
113Actual
Phase
Phase 1
Conditions
Advanced or Recurrent Solid Tumors
Breast Neoplasms
Ovarian Cancer, Epithelial
Ewing Sarcoma
Small Cell Lung Carcinoma
Prostate Cancer
Pancreas Cancer
Interventions
Talazoparib
Countries
United States
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01286987
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PRP-001
Secondary IDs
ID
Type
Description
Link
2010-023062-40
EudraCT Number
C3441007
Other Identifier
Alias Study Number
Brief Title
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
Official Title
A Phase 1, First In Human, Single-arm, Open-label Study Of Once A Day, Orally Administered Talazoparib (Bmn 673) In Patients With Advanced Or Recurrent Solid Tumors
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jun 2018
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
Jan 3, 2011Actual
Primary Completion Date
Mar 31, 2015Actual
Completion Date
Jan 30, 2017Actual
First Submitted Date
Jan 26, 2011
First Submission Date that Met QC Criteria
Jan 28, 2011
First Posted Date
Feb 1, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 31, 2018
Results First Submitted that Met QC Criteria
Jun 29, 2018
Results First Posted Date
Jan 10, 2019Actual
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
Jun 29, 2018
Last Update Posted Date
Jan 10, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
Medivation, Inc.
INDUSTRY
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced or Recurrent Solid Tumors
Breast Neoplasms
Ovarian Cancer, Epithelial
Ewing Sarcoma
Small Cell Lung Carcinoma
Prostate Cancer
Pancreas Cancer
Keywords
BRCA1 Protein
BRCA2 Protein
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
113Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Talazoparib
Experimental
Drug: Talazoparib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Talazoparib
Drug
Oral capsule with multiple dosage forms given once daily
Talazoparib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Objective Response
Objective response in participants was defined as the number of participants with complete response (CR) or partial response (PR) after treatment with talazoparib and maintained for at least 4 weeks (28 days) as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1. CR defined as disappearance of all non-nodal target lesions (where all target lesions were recorded with a length of 0 millimeter [mm] on the case report form [CRF]) and the reduction of the shortest diameter of all nodal lesions to less than [<] 10 mm. PR was defined by a 30% or more decrease in the sum of the longest diameters (SLD) + sum of shortest diameters (SSD) of target lesions, taking as reference the baseline SLD+SSD.
From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Number of Participants With Best Overall Response
Best overall response: best response (in the order of confirmed CR, confirmed PR, stable disease [SD] and progressive disease [PD]) among all overall response as RECIST 1.1, recorded from date of first dose of talazoparib until participant withdrew from study/data cut-off date, whichever earlier. CR defined as disappearance of all non-nodal target lesions (where all target lesions recorded with a length of 0 mm on the CRF) and the reduction of the shortest diameter of all nodal lesions to < 10 mm. PR defined as at least a 30% decrease in sum of the diameters of target lesions, reference to baseline sum diameters. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Progression-Free Survival (PFS)
PFS was defined as the time (in weeks) from the date of first dose of study drug to the earlier date of the documented PD or death due to any cause. PD as per RECIST 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Secondary Outcomes
Not provided
Other Outcomes
Measure
Description
Time Frame
Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study (up to 1071 days for Part 1 and up to 834 days for Part 2) that were absent before treatment or that worsened relative to pre-treatment state.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor
Must have available archived tumor tissue (formalin-fixed paraffin-embedded) [FFPE].
18 years of age or older.
Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9 (pancreatic cancer).
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Have adequate organ function
Able to take oral medications.
Willing and able to provide informed consent.
Sexually active patients must be willing to use an acceptable method of contraception.
Females of childbearing potential must have a negative serum pregnancy test at screening.
Willing and able to comply with all study procedures.
Part 2 Dose Expansion Tumor Types:
Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease.
Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 2 prior regimens for metastatic disease.
Small cell lung cancer (SCLC) patients who have received no more than one prior regimen for SCLC.
Ewing's sarcoma patients who have received no more than 3 prior regimens for metastatic disease.
Exclusion Criteria:
Part 2 Expansion: Prior treatment with a PARP inhibitor.
Has history of central nervous system (CNS) metastasis.
* Exception: In patients with SCLC, history of adequately treated brain metastasis who do not require corticosteroids for management of CNS symptoms.
Has had major surgery within 28 days before Cycle 1, Day 1.
Has active peptic ulcer disease.
Active gastrointestinal tract disease with malabsorption syndrome.
Pregnant or breastfeeding at screening or planning to become pregnant (in each case, either oneself or one's partner) at any time during the study.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Medical Director
Medivation, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Scottsdale Healthcare
Scottsdale
Arizona
85258
United States
Virginia G. Piper Cancer Center Research Pharmacy
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Study was conducted in two parts: Part 1 was dose escalation phase (to determine the maximum tolerated dose [MTD]) and Part 2 was the dose expansion phase conducted at MTD determined in Part 1. Participants were different in both of the Parts.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Periods
Title
Milestones
Reasons Not Completed
Part 1: Dose Escalation
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
BMN 673
MDV3800
Baseline, until PD or death due to any cause (maximum duration:1071 days for Part 1; 834 days for Part 2)
Duration of Response
Duration of response was defined as the time (in weeks) from the date of the first documented objective response confirmed at least 28 days later to the date of the first documented PD or date of death, whichever occurred first. PD as per RECIST version 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Baseline until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Number of Participants With Stable Disease
SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Baseline, until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Part 1: Maximum Tolerated Dose (MTD)
The MTD was defined as the highest dose at which no more than 1 of 6 participants experienced a Dose Limiting Toxicity (DLT). DLT defined as any of the following occurring during cycle 1 of part 1 of study, Hematologic toxicity: Any grade 4 or higher hematologic adverse event, Grade 3 thrombocytopenia associated with grade 2 or higher haemorrhage, Grade 3 thrombocytopenia or neutropenia that led to interruption of dosing for 5 or more days. Nonhematologic toxicity: grade 3 or higher laboratory AE which was asymptomatic and rapidly reversible adverse events (returned to baseline or to grade 1 or lower within 7 days), Grade 3 nausea, vomiting, or diarrhea that could be medically managed to grade 2 or lower with anti-emetics and/or anti-diarrheals within 24 hours, Grade 3 fatigue that improved to grade 2 or lower in 5 days or less, Alopecia. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Cycle 1 (Day 1 up to Day 42)
Part 1: Recommended Part 2 Dose of Talazoparib
The Recommended dose of talazoparib for use in Part 2 was determined in Part 1 (dose escalation) on the basis of the totality of safety, pharmacokinetics (PK), pharmacodynamic and preliminary efficacy data observed in Cycles 1 and 2 and beyond.
Baseline up to Cycle 50 (each cycle 28 days)
Part 1: Baseline up to 1071 days; Part 2: Baseline up to 834 days
Part 1: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35
Part 2: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35
Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1
Part 1: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUC0-last) of Talazoparib
Area under the plasma concentration time-curve from zero to the time of last measured concentration (AUC0-last).
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1
Part 2: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUC0-last) of Talazoparib
Area under the plasma concentration time-curve from zero to the time of last measured concentration (AUC0-last).
Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1
Part 1: Minimum Observed Plasma Concentration (Cmin) of Talazoparib
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 35
Part 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of Talazoparib
AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1
Part 1: Terminal Half-Life (t1/2) of Talazoparib
T1/2 is the time measured for the plasma concentration of talazoparib to decrease by one half.
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35
Part 1: Apparent Oral Clearance (CL/F) of Talazoparib
Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed.
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1
Part 1: Apparent Volume of Distribution (Vz/F) of Talazoparib
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F was influenced by the fraction absorbed.
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35
Scottsdale
Arizona
85258
United States
(IRB# 12-000131) Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles
California
90095
United States
Ronald Reagan UCLA Medical Center
Los Angeles
California
90095
United States
UCLA Hematology/Oncology
Los Angeles
California
90095
United States
Westwood Bowyer Clinic, Peter Morton Medical Building
Los Angeles
California
90095
United States
Santa Monica - UCLA Medical Center & Orthopaedic Hospital
Santa Monica
California
90404
United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica
California
90404
United States
IU Health Bloomington Hospital
Bloomington
Indiana
47403
United States
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis
Indiana
46202
United States
Investigational Drug Services
Indianapolis
Indiana
46202
United States
IU Health University Hospital
Indianapolis
Indiana
46202
United States
University of Michigan Health System
Ann Arbor
Michigan
48109
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030-4009
United States
Royal Marsden Hospital NHS Foundation Trust
Sutton
Surrey
SM2 5PT
United Kingdom
FG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG002
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG009
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG010
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG011
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG012
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG013
Part 2: Talazoparib (SCLC Cancer)
Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG014
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0056 subjects
FG0066 subjects
FG0076 subjects
FG0086 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Colorectal Cancer
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Prostate Cancer
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Ewing Cancer
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Pancreatic Cancer
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Ovarian/ Peritoneal Cancer
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG0043 subjects
FG0054 subjects
FG0064 subjects
FG0073 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Breast Cancer
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0083 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0056 subjects
FG0065 subjects
FG0075 subjects
FG0086 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type
Comment
Reasons
Clinical Progression
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Progressive Disease
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2: Dose Expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00912 subjects
FG01012 subjects
FG01111 subjects
FG01212 subjects
FG01324 subjects
FG0143 subjects
Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety analysis set included all enrolled participants who received at least 1 dose of talazoparib.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG002
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG009
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG010
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG011
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG012
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG013
Part 2: Talazoparib (SCLC Cancer)
Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG014
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0033
BG0043
BG0056
BG0066
BG0076
BG0086
BG00912
BG01011
BG01110
BG01212
BG01323
BG0143
BG015110
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
BG00077.7± 3.51
BG00166.7± 9.07
BG00264.0± 9.64
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
American Indian or Alaska Native
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
Number of Participants With Objective Response
Objective response in participants was defined as the number of participants with complete response (CR) or partial response (PR) after treatment with talazoparib and maintained for at least 4 weeks (28 days) as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1. CR defined as disappearance of all non-nodal target lesions (where all target lesions were recorded with a length of 0 millimeter [mm] on the case report form [CRF]) and the reduction of the shortest diameter of all nodal lesions to less than [<] 10 mm. PR was defined by a 30% or more decrease in the sum of the longest diameters (SLD) + sum of shortest diameters (SSD) of target lesions, taking as reference the baseline SLD+SSD.
Response analysis population: all enrolled participants who had at least 1 dose of talazoparib, and measurable disease at baseline. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type.
Posted
Number
participants
From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
ID
Title
Description
OG000
Part 1 and Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
OG001
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
OG002
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 1000 mcg/day.
OG003
Part 1 and Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 1000 mcg/day, 1100 mcg/day.
OG004
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
OG005
Part 1 and Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer who received talazoparib capsules in Part 1 and 2 at a dose of 600 mcg/day.
OG006
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
Units
Counts
Participants
OG00020
OG00131
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG0008
OG00112
OG0022
OG003
Primary
Number of Participants With Best Overall Response
Best overall response: best response (in the order of confirmed CR, confirmed PR, stable disease [SD] and progressive disease [PD]) among all overall response as RECIST 1.1, recorded from date of first dose of talazoparib until participant withdrew from study/data cut-off date, whichever earlier. CR defined as disappearance of all non-nodal target lesions (where all target lesions recorded with a length of 0 mm on the CRF) and the reduction of the shortest diameter of all nodal lesions to < 10 mm. PR defined as at least a 30% decrease in sum of the diameters of target lesions, reference to baseline sum diameters. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Response analysis population: all enrolled participants who had at least 1 dose of talazoparib, and measurable disease at baseline. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type and was not planned to be analyzed for "Part 1: Colorectal Cancer" arm, as pre-specified in protocol.
Posted
Number
participants
From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
ID
Title
Description
OG000
Part 1 and Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
Primary
Progression-Free Survival (PFS)
PFS was defined as the time (in weeks) from the date of first dose of study drug to the earlier date of the documented PD or death due to any cause. PD as per RECIST 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Full analysis set (FAS) included all enrolled participants who received at least 1 dose of talazoparib. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type and was not planned to be analyzed for "Part 1: Colorectal Cancer" arm, as pre-specified in protocol.
Posted
Median
95% Confidence Interval
weeks
Baseline, until PD or death due to any cause (maximum duration:1071 days for Part 1; 834 days for Part 2)
ID
Title
Description
OG000
Part 1 and Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
OG001
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
Primary
Duration of Response
Duration of response was defined as the time (in weeks) from the date of the first documented objective response confirmed at least 28 days later to the date of the first documented PD or date of death, whichever occurred first. PD as per RECIST version 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Analysis performed on subset of response analysis population which included participants who had objective response. Data for outcome measure was planned to be analyzed combined for Part 1 and Part 2. "Overall number of participants analyzed" is zero (0) for arms of ewing, prostate, CLC cancer, since none of the participants had objective response.
Posted
Median
95% Confidence Interval
weeks
Baseline until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
ID
Title
Description
OG000
Part 1 and Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
OG001
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
Primary
Number of Participants With Stable Disease
SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).
Response analysis population: all enrolled participants who had at least 1 dose of talazoparib, and measurable disease at baseline. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type and was not planned to be analyzed for "Part 1: Colorectal Cancer" arm, as pre-specified in protocol.
Posted
Number
participants
Baseline, until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
ID
Title
Description
OG000
Part 1 and Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
OG001
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
Primary
Part 1: Maximum Tolerated Dose (MTD)
The MTD was defined as the highest dose at which no more than 1 of 6 participants experienced a Dose Limiting Toxicity (DLT). DLT defined as any of the following occurring during cycle 1 of part 1 of study, Hematologic toxicity: Any grade 4 or higher hematologic adverse event, Grade 3 thrombocytopenia associated with grade 2 or higher haemorrhage, Grade 3 thrombocytopenia or neutropenia that led to interruption of dosing for 5 or more days. Nonhematologic toxicity: grade 3 or higher laboratory AE which was asymptomatic and rapidly reversible adverse events (returned to baseline or to grade 1 or lower within 7 days), Grade 3 nausea, vomiting, or diarrhea that could be medically managed to grade 2 or lower with anti-emetics and/or anti-diarrheals within 24 hours, Grade 3 fatigue that improved to grade 2 or lower in 5 days or less, Alopecia. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Safety analysis set included all enrolled participants who received at least 1 dose of talazoparib.
Posted
Number
mcg/day
Cycle 1 (Day 1 up to Day 42)
ID
Title
Description
OG000
Part 1: Talazoparib: All Participants
All participants who received talazoparib capsules in part 1 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day and 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Primary
Part 1: Recommended Part 2 Dose of Talazoparib
The Recommended dose of talazoparib for use in Part 2 was determined in Part 1 (dose escalation) on the basis of the totality of safety, pharmacokinetics (PK), pharmacodynamic and preliminary efficacy data observed in Cycles 1 and 2 and beyond.
Safety analysis set included all enrolled participants who received at least 1 dose of talazoparib.
Posted
Number
mcg/day
Baseline up to Cycle 50 (each cycle 28 days)
ID
Title
Description
OG000
Part 1: Talazoparib: All Participants
All participants who received talazoparib capsules in part 1 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day and 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Units
Counts
Participants
OG000
Other Pre-specified
Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study (up to 1071 days for Part 1 and up to 834 days for Part 2) that were absent before treatment or that worsened relative to pre-treatment state.
Safety analyses set included all enrolled participants who received at least 1 dose of talazoparib.
Posted
Number
participants
Part 1: Baseline up to 1071 days; Part 2: Baseline up to 834 days
ID
Title
Description
OG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Other Pre-specified
Part 1: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
The pharmacokinetic (PK) evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints.
Posted
Mean
Standard Deviation
picograms per milliliter (pg/mL)
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35
ID
Title
Description
OG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG002
Part 1: Talazoparib 100 mcg/Day
Other Pre-specified
Part 2: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. PK data was planned to be reported for the overall participants in Part 2, as pre-specified in protocol.
Posted
Mean
Standard Deviation
pg/mL
Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1
ID
Title
Description
OG000
Part 2: Talazoparib 1000 mcg
All participants with either breast, ovarian/peritoneal, pancreatic, ewing, SCLC, or prostate cancer who received talazoparib capsules at a dose of 1000 mcg/day in Part 2.
Units
Counts
Participants
OG000
Other Pre-specified
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints.
Posted
Median
Full Range
hours
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35
ID
Title
Description
OG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG002
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Other Pre-specified
Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. PK data was planned to be reported for the overall participants in Part 2, as pre-specified in protocol.
Posted
Median
Full Range
hours
Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1
ID
Title
Description
OG000
Part 2: Talazoparib 1000 mcg
All participants with either breast, ovarian/peritoneal, pancreatic, ewing, SCLC, or prostate cancer who received talazoparib capsules at a dose of 1000 mcg/day in Part 2.
Units
Counts
Participants
OG000
Other Pre-specified
Part 1: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUC0-last) of Talazoparib
Area under the plasma concentration time-curve from zero to the time of last measured concentration (AUC0-last).
The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints.
Posted
Mean
Standard Deviation
picograms*hour per mililiter (pg*hr/mL)
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1
ID
Title
Description
OG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Other Pre-specified
Part 2: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUC0-last) of Talazoparib
Area under the plasma concentration time-curve from zero to the time of last measured concentration (AUC0-last).
The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. PK data was planned to be reported for the overall participants in Part 2, as pre-specified in protocol.
Posted
Mean
Standard Deviation
pg*hr/mL
Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1
ID
Title
Description
OG000
Part 2: Talazoparib 1000 mcg
All participants with either breast, ovarian/peritoneal, pancreatic, ewing, SCLC, or prostate cancer who received talazoparib capsules at a dose of 1000 mcg/day in Part 2.
Units
Counts
Participants
OG000
Other Pre-specified
Part 1: Minimum Observed Plasma Concentration (Cmin) of Talazoparib
The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.
Posted
Mean
Standard Deviation
pg/mL
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 35
ID
Title
Description
OG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG002
Part 1: Talazoparib 100 mcg/Day
Other Pre-specified
Part 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of Talazoparib
AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.
Posted
Mean
Standard Deviation
pg*hr/mL
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1
ID
Title
Description
OG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Other Pre-specified
Part 1: Terminal Half-Life (t1/2) of Talazoparib
T1/2 is the time measured for the plasma concentration of talazoparib to decrease by one half.
The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.
Posted
Mean
Standard Deviation
Hours
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35
ID
Title
Description
OG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Other Pre-specified
Part 1: Apparent Oral Clearance (CL/F) of Talazoparib
Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed.
The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.
Posted
Mean
Standard Deviation
liter/hour
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1
ID
Title
Description
OG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Other Pre-specified
Part 1: Apparent Volume of Distribution (Vz/F) of Talazoparib
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F was influenced by the fraction absorbed.
The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.
Posted
Mean
Standard Deviation
liter
Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35
ID
Title
Description
OG000
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Time Frame
Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Description
Analysis performed on safety population. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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
Part 1: Talazoparib 25 mcg/Day
Participants received talazoparib capsules at a dose of 25 microgram per day (mcg/day) once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
1
3
2
3
EG001
Part 1: Talazoparib 50 mcg/Day
Participants received talazoparib capsules at a dose of 50 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
2
3
3
3
EG002
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
2
3
2
3
EG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
3
3
3
3
EG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
0
3
3
3
EG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
2
6
6
6
EG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
3
6
6
6
EG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
2
6
6
6
EG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
3
6
6
6
EG009
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
2
12
12
12
EG010
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
5
11
11
11
EG011
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
6
10
10
10
EG012
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
4
12
12
12
EG013
Part 2: Talazoparib (SCLC Cancer)
Participants with SCLC cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
8
23
20
23
EG014
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
0
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ascites
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected12 at risk
EG0100 affected11 at risk
EG0110 affected10 at risk
EG0120 affected12 at risk
EG0130 affected23 at risk
EG0140 affected3 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Community acquired infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Anastomotic stenosis
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Otitis media
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Disease progression
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Transaminases increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pubis fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ovarian neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected12 at risk
EG0100 affected11 at risk
EG0110 affected10 at risk
EG0120 affected12 at risk
EG0131 affected23 at risk
EG0140 affected3 at risk
Bundle branch block left
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cataract
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eye pain
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eye swelling
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oesophagitis ulcerative
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abnormal faeces
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Femoral hernia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral mucosal erythema
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Early satiety
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Axillary pain
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Catheter site pain
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Local swelling
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Medical device site reaction
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Discomfort
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Feeling hot
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sensation of foreign body
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Temperature intolerance
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Feeling abnormal
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Feeling cold
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Localised oedema
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nodule
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thirst
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Autoimmune disorder
Immune system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Skin candida
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Breast abscess
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Otitis media
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anastomotic stenosis
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Injury corneal
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diastasis recti abdominis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Limb mass
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Stress
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anaemia vitamin B12 deficiency
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Biopsy bone marrow
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood chloride decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Transaminases increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Troponin increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood potassium increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urogenital haemorrhage
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Micturition frequency decreased
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Genital discomfort
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Penile pain
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Adnexa uteri pain
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Prostatic pain
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lung hyperinflation
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Throat tightness
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea at rest
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nail bed disorder
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Penile ulceration
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin swelling
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotrichosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphostasis
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ear pruritus
Ear and labyrinth disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ear swelling
Ear and labyrinth disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neoplasm skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Breast reconstruction
Surgical and medical procedures
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Frontal sinus operation
Surgical and medical procedures
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D001943
Breast Neoplasms
D000077216
Carcinoma, Ovarian Epithelial
D012512
Sarcoma, Ewing
D055752
Small Cell Lung Carcinoma
D011471
Prostatic Neoplasms
D010190
Pancreatic Neoplasms
C563980
Fanconi Anemia, Complementation Group D1
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D010051
Ovarian Neoplasms
D004701
Endocrine Gland Neoplasms
D010049
Ovarian Diseases
D000291
Adnexal Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
D012516
Osteosarcoma
D018213
Neoplasms, Bone Tissue
D009372
Neoplasms, Connective Tissue
D018204
Neoplasms, Connective and Soft Tissue
D012509
Sarcoma
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D005834
Genital Neoplasms, Male
D005832
Genital Diseases, Male
D011469
Prostatic Diseases
D052801
Male Urogenital Diseases
D004067
Digestive System Neoplasms
D004066
Digestive System Diseases
D010182
Pancreatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C586365
talazoparib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0055 subjects
FG0065 subjects
FG0073 subjects
FG0085 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00912 subjects
FG01011 subjects
FG01110 subjects
FG01212 subjects
FG01323 subjects
FG0143 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0102 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00911 subjects
FG01010 subjects
FG01110 subjects
FG01212 subjects
FG01324 subjects
FG0142 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0131 subjects
FG0140 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00911 subjects
FG0106 subjects
FG0117 subjects
FG01211 subjects
FG01319 subjects
FG0142 subjects
Clinical Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
FG0112 subjects
FG0120 subjects
FG0132 subjects
FG0140 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
48.7
± 11.50
BG00460.7± 5.77
BG00561.3± 19.00
BG00648.2± 8.66
BG00745.0± 18.25
BG00838.8± 13.73
BG00946.5± 11.47
BG01054.2± 10.93
BG01165.2± 7.71
BG01228.7± 15.18
BG01364.0± 10.45
BG01457.3± 8.14
BG01553.7± 16.80
3
BG0033
BG0043
BG0055
BG0066
BG0075
BG0085
BG00911
BG01011
BG0114
BG0126
BG01311
BG0140
BG01576
Male
BG0001
BG0012
BG0020
BG0030
BG0040
BG0051
BG0060
BG0071
BG0081
BG0091
BG0100
BG0116
BG0126
BG01312
BG0143
BG01534
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0092
BG0100
BG0110
BG0120
BG0130
BG0140
BG0153
Black or African American
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0091
BG0100
BG0110
BG0121
BG0130
BG0140
BG0153
Native Hawaiian or Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
White
Title
Measurements
BG0003
BG0013
BG0023
BG0033
BG0043
BG0056
BG0065
BG0075
BG0084
BG0099
BG01011
BG01110
BG01210
BG01323
BG0143
BG015101
Other
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0071
BG0080
BG0090
BG0100
BG0110
BG0121
BG0130
BG0140
BG0153
14
OG00423
OG0051
OG0062
0
OG0042
OG0050
OG0060
OG001
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 100 mcg/day, 200 mcg/day, 400 mcg/day, 600 mcg/day, 900 mcg/day, 1000 mcg/day, 1100 mcg/day.
OG002
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 1000 mcg/day.
OG003
Part 1 and Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 1000 mcg/day, 1100 mcg/day.
OG004
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
OG005
Part 1 and Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer who received talazoparib capsules in Part 1 and 2 at a dose of 600 mcg/day.
Units
Counts
Participants
OG00020
OG00131
OG00213
OG00314
OG00423
OG0051
Title
Denominators
Categories
Complete Response (CR)
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0040
OG0050
Partial Response (PR)
Title
Measurements
OG0007
OG00111
OG0022
OG003
Stable Disease (SD)
Title
Measurements
OG0007
OG00110
OG0022
OG003
Progressive Disease (PD)
Title
Measurements
OG0005
OG0016
OG0026
OG003
OG002
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 1000 mcg/day.
OG003
Part 1 and Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 1000 mcg/day, 1100 mcg/day.
OG004
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
OG005
Part 1 and Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer who received talazoparib capsules in Part 1 and 2 at a dose of 600 mcg/day.
Units
Counts
Participants
OG00020
OG00134
OG00213
OG00314
OG00423
OG0054
Title
Denominators
Categories
Title
Measurements
OG00029.3(12.1 to 43.4)
OG00132.1(18.9 to 38.6)
OG0025.3(2.4 to 21.3)
OG0036.2(3.1 to 14.0)
OG00411.1(4.3 to 13.0)
OG00512.1(12.0 to NA)
OG002
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 1000 mcg/day.
OG003
Part 1 and Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 1000 mcg/day, 1100 mcg/day.
OG004
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
OG005
Part 1 and Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer who received talazoparib capsules in Part 1 and 2 at a dose of 600 mcg/day.
OG006
Part 1: Talazoparib (Colorectal Cancer)
Participants with colorectal cancer who received talazoparib capsules in Part 1 at a dose of either 25 mcg or 100 mcg/day.
Units
Counts
Participants
OG0008
OG00112
OG0022
OG0030
OG0042
OG0050
OG0060
Title
Denominators
Categories
Title
Measurements
OG00032.2(20.1 to 64.1)
OG00126.9(15.7 to 35.1)
OG002NA(21.6 to NA)Median and Upper limit of 95% CI were not estimable due to the less number of participants with events
OG00413.6(12.0 to 15.3)
OG002
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 25 mcg/day, 50 mcg/day, 1000 mcg/day.
OG003
Part 1 and Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer who received talazoparib capsules in Part 1 and 2 at a dose of either 1000 mcg/day, 1100 mcg/day.
OG004
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
OG005
Part 1 and Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer who received talazoparib capsules in Part 1 and 2 at a dose of 600 mcg/day.
Units
Counts
Participants
OG00020
OG00131
OG00213
OG00314
OG00423
OG0051
Title
Denominators
Categories
Title
Measurements
OG0007
OG00110
OG0022
OG0034
OG0044
OG0051
Units
Counts
Participants
OG00039
Title
Denominators
Categories
Title
Measurements
OG0001000
39
Title
Denominators
Categories
Title
Measurements
OG0001000
OG002
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG009
Part 2: Talazoparib (Breast Cancer)
Participants with breast cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG010
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)
Participants with ovarian/ peritoneal cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG011
Part 2: Talazoparib (Pancreatic Cancer)
Participants with pancreatic cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG012
Part 2: Talazoparib (Ewing Cancer)
Participants with ewing cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG013
Part 2: Talazoparib (SCLC Cancer)
Participants with small cell lung cancer (SCLC) cancer who received talazoparib capsules in Part 2 at a dose of 1000 mcg/day.
OG014
Part 2: Talazoparib (Prostate Cancer)
Participants with prostate cancer, received talazoparib capsules at the MTD as determined in Part 1 (1000 mcg/day), orally once daily in each 28-day treatment cycle (up to a maximum of 40 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0056
OG0066
OG0076
OG0086
OG00912
OG01011
OG01110
OG01212
OG01323
OG0143
Title
Denominators
Categories
AEs
Title
Measurements
OG0002
OG0013
OG0022
OG0033
OG0043
OG0056
OG0066
OG0076
OG0086
OG00912
OG01011
OG01110
OG01212
OG01321
OG0142
SAEs
Title
Measurements
OG0001
OG0012
OG0022
OG003
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG0086
Title
Measurements
OG00060.0± 15.9
OG00179.7± 7.50
OG002214± 50.9
OG003
Cycle 1 Day 35
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
70
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00070
Title
Measurements
OG0008480± 3890
Cycle 2 Day 1
ParticipantsOG00041
Title
Measurements
OG00017700± 5790
OG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG0086
Title
Measurements
OG0007.92(1.95 to 9.95)
OG0011.00(0.800 to 1.02)
OG0021.02(1.00 to 3.98)
OG003
Cycle 1 Day 35
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
70
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00070
Title
Measurements
OG0001.00(0.500 to 4.07)
Cycle 2 Day 1
ParticipantsOG00041
Title
Measurements
OG0001.07(0.500 to 6.05)
OG002
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Title
Measurements
OG0003600± 1360
OG0015340± 1960
OG00216600± 5320
OG00339300± 11700
OG00443700± 15000
OG00597900± 30000
OG006160000± 66100
OG007182000± 62400
OG008201000± 93400
70
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00070
Title
Measurements
OG00019100± 8850
Cycle 2 Day 1
ParticipantsOG00041
Title
Measurements
OG00050200± 16300
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Title
Measurements
OG000169± 58.0
OG001299± 133
OG0021020± 107
OG0032880± 1710
OG0042230± 957
OG0053470± 1050
OG0063180± 802
OG0073720± 1590
OG0082910± 803
OG002
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Title
Measurements
OG0005330± 1840
OG0018320± 1960
OG00237600± 6620
OG00392700± 48500
OG00460100± 15900
OG005120000± 26000
OG006188000± 85700
OG007200000± 64000
OG008235000± 111000
OG002
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG0086
Title
Measurements
OG000100± 11.9
OG001129± 42.6
OG002229± 158
OG003
Cycle 1 Day 35
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
OG002
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Title
Measurements
OG0005.17± 2.10
OG0016.27± 1.66
OG0022.72± 0.532
OG0032.61± 1.35
OG0046.95± 1.71
OG0055.19± 0.990
OG0065.49± 2.08
OG0075.39± 1.59
OG0085.32± 1.64
OG002
Part 1: Talazoparib 100 mcg/Day
Participants received talazoparib capsules at a dose of 100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG003
Part 1: Talazoparib 200 mcg/Day
Participants received talazoparib capsules at a dose of 200 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG004
Part 1: Talazoparib 400 mcg/Day
Participants received talazoparib capsules at a dose of 400 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG005
Part 1: Talazoparib 600 mcg/Day
Participants received talazoparib capsules at a dose of 600 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG006
Part 1: Talazoparib 900 mcg/Day
Participants received talazoparib capsules at a dose of 900 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG007
Part 1: Talazoparib 1000 mcg/Day
Participants received talazoparib capsules at a dose of 1000 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.
OG008
Part 1: Talazoparib 1100 mcg/Day
Participants received talazoparib capsules at a dose of 1100 mcg/day once daily from Day 8 to 35 of Cycle 1 and thereafter once daily in each 28-day treatment cycle starting from Cycle 2 (up to a maximum of 50 cycles) until documented disease progression or unacceptable toxicity, or until study discontinuation criteria were met.