Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Official Title
A Phase 1/2 Trial of ABT-888, an Inhibitor of Poly(ADP-ribose) Polymerase (PARP), and Topotecan (TPT) in Patients With Solid Tumors (Phase 1) and Relapsed Ovarian Cancer or Primary Peritoneal Cancer (Phase 2) After Prior Platinum Containing First-Line Chemotherapy
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Mar 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 3, 2009Actual
Primary Completion Date
Jan 13, 2019Actual
Completion Date
Mar 10, 2027Estimated
First Submitted Date
Nov 11, 2009
First Submission Date that Met QC Criteria
Nov 11, 2009
First Posted Date
Nov 13, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 29, 2023
Results First Submitted that Met QC Criteria
Jun 29, 2023
Results First Posted Date
Jul 19, 2023Actual
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
Apr 9, 2026
Last Update Posted Date
Apr 29, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Cancer Institute (NCI)NIH
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This phase I/II trial studies the side effects and best dose of veliparib and topotecan hydrochloride and to see how well they work in treating patients with solid tumors, ovarian cancer that has come back or does not respond to treatment, or primary peritoneal cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib with chemotherapy may kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of the combination of veliparib (ABT-888) and weekly topotecan (topotecan hydrochloride) in adult patients with advanced solid tumors. (Phase I) II. To identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors. (Phase I) III. To assess the confirmed response rate for patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma treated with the combination of ABT-888 and weekly topotecan.
IV. To assess the progression free response (PFS) for patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma treated with the combination of ABT-888 and weekly topotecan. (Phase II)
SECONDARY OBJECTIVES:
I. To identify any pharmacokinetic interactions between ABT-888 and topotecan. (Phase I) II. To determine whether topotecan stimulates adenosine diphosphate (ADP)-ribose polymer formation in circulating peripheral blood mononuclear cells. (Phase I) III. To determine whether ABT-888 inhibits basal or topotecan-stimulated ADP-ribose polymer formation. (Phase I) IV. To assess differences in the toxicity and/or efficacy of this regimen based on BRCA 1/2 mutational status. (Phase II) V. To determine whether pretreatment tumor cell levels of topoisomerase I, poly ADP-ribose polymerase (PARP), BRCA1, BRCA2, XRCC1, tyrosyl-deoxyribonucleic acid (DNA) phosphodiesterase 1 (TDP1), P-glycoprotein or breast cancer resistance protein (BCRP) predict response to this regimen. (Phase II) VI. To identify, in an exploratory manner, any transcriptional profiles that may predict response to this regimen. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of veliparib and topotecan hydrochloride followed by a phase II study. (PHASE I DOSE-ESCALATION PART IS COMPLETED)
Patients receive veliparib orally (PO) on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and topotecan hydrochloride intravenously (IV) over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months (Phase I) or every 3 or 6 months for 5 years (Phase II).
Conditions Module
Conditions
Metastatic Malignant Solid Neoplasm
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Unresectable Solid Neoplasm
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
88Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment (veliparib and topotecan hydrochloride)
Experimental
Patients receive veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Other: Pharmacological Study
Drug: Topotecan Hydrochloride
Drug: Veliparib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Laboratory Biomarker Analysis
Other
Correlative studies
Treatment (veliparib and topotecan hydrochloride)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)
The number of patients with a dose limiting toxicity will be reported. Dose-limiting toxicity (DLT) will be defined as a cycle 1 adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria: Grade 4 anemia, grade 4 neutrophil count decrease, grade 4 platelet count decrease, Serum creatinine >= 2 times baseline or ≥ 2 times the upper limit of normal if baseline is < the upper limit of normal, or other >= Grade 3 as per NCI Common Terminology Criteria for Adverse Events CTCAE version 4.0. >= Grade 3 nausea, vomiting, or diarrhea with maximal supportive treatment(s) will be considered dose-limiting. Grade 3 fatigue or anorexia will not be considered dos
4 weeks
Percent of Patients With Tumor Response, Defined as Complete Response or Partial Response as Assessed Using Response Evaluation Criteria In Solid Tumors
The proportion of successes will be estimated by the number of successes(CR or PR) divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987). Complete Response (CR) is defined as disappearance of all target lesions and, if non target lesions exist, the disappearance of all non-target lesions and normalization of tumor maker level. At least 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum.
Up to 48 weeks (12 courses)
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival
The distribution of survival time for phase 2 patients will be estimated using the method of Kaplan-Meier.
The time from registration to death due to any cause, assessed up to 5 years
Progression Free Survival
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
PHASE I: Adult patients with histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative measures or other therapy definitely capable of extending life expectancy does not exist
PHASE II: All patients enrolled in the Phase II portion of this trial must have a history of biopsy-proven ovarian, fallopian tube or primary peritoneal cancer
Patients must have received < 3 lines of prior therapy and have relapsed less than a year from their last platinum regimen; regimens that are used twice (for example carboplatin and paclitaxel) can be counted as one; if a regimen is changed during the course of treatment due to side effect profile or allergy, the course of therapy is counted as one regimen; (for example, if docetaxel is substituted for paclitaxel due to a reaction during the initial course of adjuvant therapy, this is considered one regimen)
Patients must have measurable disease with at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed topography (CT); if spiral CT is used, it must be used for both pre- and post- treatment tumor assessments
Absolute neutrophil count >= 1500/mcL
Hemoglobin >= 9.0 g/dL
Platelets >= 100,000/mcL
Total bilirubin =< 1.5 x the upper limit of normal (ULN)
Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 x ULN in the absence of hepatic metastasis; SGPT (ALT) =< 3 x ULN or SGOT (AST) =< 5 x ULN in the presences of hepatic metastasis
Creatinine =< 1.5 x ULN
International normalized ratio (INR) =< 1.4 unless receiving therapeutic doses of coumadin
Partial thromboplastin time (PTT) =< 48 seconds (1.25 x ULN)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Ability to provide informed consent
Willingness to return to enrolling institution for follow up
Life expectancy >= 12 weeks
Willingness to provide the biologic specimens is required by the protocol; this is part of the mandatory correlative research component; these specimens include:
PHASE I: peripheral blood for plasma pharmacokinetic analysis and peripheral blood mononuclear cell (PBMC) polymer assessment from 0-24 h after drug administration on days 1 and 2 of cycle 1 as well as day 2 of cycle 2; urine for assessment of ABT-888 renal clearance for 24 h after administration of drugs on days 1 and 2 of cycle 1 as well as day 2 of cycle 2; and a pretreatment peripheral blood sample for possible sequencing of the BRCA1, BRCA2 loci as well as possible pharmacogenomic analysis
Negative urine or serum pregnancy test done =< 7 days prior to registration for females of child bearing potential only
Able to swallow and absorb the medication
Exclusion Criteria:
Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
Prior treatment with a PARP inhibitor or topotecan
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Any of the following prior therapies:
Chemotherapy =< 4 weeks prior to registration
Mitomycin C/nitrosoureas =< 6 weeks prior to registration
Immunotherapy =< 4 weeks prior to registration
Biologic therapy =< 4 weeks prior to registration
Radiation therapy =< 4 weeks prior to registration
Radiation to > 25% of bone marrow
Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) =< 4 weeks prior to registration; subjects with prostate cancer will be permitted to continue hormone therapy
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
New York Heart Association classification III or IV
Known central nervous system (CNS) metastases or seizure disorder; patients with known brain metastases that have been successfully treated and stable for >= 6 months without requirement for corticosteroids and without seizure activity will be eligible
Any of the following:
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy, except non-melanotic skin cancer or carcinoma-in-situ of the cervix
Note: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
More than 2 prior chemotherapy regimens for the current malignancy; full dose chemotherapy used in conjunction with concurrent radiation therapy will be included as prior therapy
Note: Prior hormonal therapy (e.g. leuprolide, aromatase inhibitors, tamoxifen) and immunotherapy will be allowed and not included as a prior chemotherapy; if the chemotherapy regimen is altered during the course due to issues with tolerability or safety, the regimen will be counted as one; using the same regimen at recurrence is counted as one regimen; the addition of bevacizumab to a prior regimen is considered one regimen
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
Andrea E Wahner Hendrickson
Mayo Clinic Cancer Center LAO
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Mayo Clinic Hospital in Arizona
Phoenix
Arizona
85054
United States
Mayo Clinic in Arizona
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1 Dose Level 1
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jan 13, 2017
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
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
Pharmacogenomic Study
Other
Correlative studies
Treatment (veliparib and topotecan hydrochloride)
PHARMACOGENOMIC
Pharmacological Study
Other
Correlative studies
Treatment (veliparib and topotecan hydrochloride)
Topotecan Hydrochloride
Drug
Given IV
Treatment (veliparib and topotecan hydrochloride)
Evotopin
Hycamptamine
Hycamtin
Nogitecan Hydrochloride
Potactasol
SKF S 104864 A
SKF S-104864-A
SKF S104864A
Topotec
Topotecan HCl
topotecan hydrochloride (oral)
Veliparib
Drug
Given PO
Treatment (veliparib and topotecan hydrochloride)
ABT 888
ABT-888
ABT888
PARP-1 inhibitor ABT-888
The distribution of progression free survival will be estimated using the method of Kaplan-Meier.
The time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
Duration of Response
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a complete response or partial response to the earliest date progression is documented.
Up to 5 years
Time to Treatment Failure
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, assessed up to 5 years
Adverse Events, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Up to 5 years
Scottsdale
Arizona
85259
United States
University of California Davis Comprehensive Cancer Center
Sacramento
California
95817
United States
UCHealth University of Colorado Hospital
Aurora
Colorado
80045
United States
Mayo Clinic in Florida
Jacksonville
Florida
32224-9980
United States
University of Chicago Comprehensive Cancer Center
Chicago
Illinois
60637
United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox
Illinois
60451
United States
University of Chicago Medicine-Orland Park
Orland Park
Illinois
60462
United States
University of Kansas Clinical Research Center
Fairway
Kansas
66205
United States
University of Kentucky/Markey Cancer Center
Lexington
Kentucky
40536
United States
Mayo Clinic in Rochester
Rochester
Minnesota
55905
United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
Pennsylvania
15232
United States
Parkland Memorial Hospital
Dallas
Texas
75235
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Texas
75390
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City
Utah
84112
United States
Phase 1 Dose Level 2
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG002
Phase 1 Dose Level 3
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG003
Phase 1 Dose Level 4
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG004
Phase 1 Dose Level 5
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG005
Phase 1 Dose Level 6
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG006
Phase 1 Dose Level 7
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG007
Phase 1 Dose Level 8
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG008
Phase 1 Dose Level 9
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG009
Phase 1 Dose Level 10
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG010
Phase 1 Dose Level 11
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG011
Phase 1 Dose Level 12
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG012
Phase 1 Dose Level 13
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG013
Phase 2
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0046 subjects
FG0057 subjects
FG0063 subjects
FG0074 subjects
FG0083 subjects
FG0096 subjects
FG0105 subjects
FG0117 subjects
FG0123 subjects
FG01331 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0046 subjects
FG0056 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0096 subjects
FG0103 subjects
FG0116 subjects
FG0123 subjects
FG01329 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
FG0111 subjects
FG0120 subjects
FG0132 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
FG0131 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1 Dose Level 1
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG001
Phase 1 Dose Level 2
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG002
Phase 1 Dose Level 3
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG003
Phase 1 Dose Level 4
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG004
Phase 1 Dose Level 5
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG005
Phase 1 Dose Level 6
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG006
Phase 1 Dose Level 7
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG007
Phase 1 Dose Level 8
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG008
Phase 1 Dose Level 9
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG009
Phase 1 Dose Level 10
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG010
Phase 1 Dose Level 11
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG011
Phase 1 Dose Level 12
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG012
Phase 1 Dose Level 13
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG013
Phase 2
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0034
BG0046
BG0057
BG0063
BG0074
BG0083
BG0096
BG0105
BG0117
BG0123
BG01331
BG01488
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Inter-Quartile Range
years
Title
Denominators
Categories
Title
Measurements
BG00052(47 to 56)
BG00158.7(53 to 64)
BG00267.7(59 to 77)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)
The number of patients with a dose limiting toxicity will be reported. Dose-limiting toxicity (DLT) will be defined as a cycle 1 adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria: Grade 4 anemia, grade 4 neutrophil count decrease, grade 4 platelet count decrease, Serum creatinine >= 2 times baseline or ≥ 2 times the upper limit of normal if baseline is < the upper limit of normal, or other >= Grade 3 as per NCI Common Terminology Criteria for Adverse Events CTCAE version 4.0. >= Grade 3 nausea, vomiting, or diarrhea with maximal supportive treatment(s) will be considered dose-limiting. Grade 3 fatigue or anorexia will not be considered dos
All phase 1 patients that received treatment per protocol and evaluated for adverse events.
Posted
Count of Participants
Participants
4 weeks
ID
Title
Description
OG000
Phase 1 Dose Level 1
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG001
Phase 1 Dose Level 2
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG002
Phase 1 Dose Level 3
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG003
Phase 1 Dose Level 4
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG004
Phase 1 Dose Level 5
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG005
Phase 1 Dose Level 6
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Percent of Patients With Tumor Response, Defined as Complete Response or Partial Response as Assessed Using Response Evaluation Criteria In Solid Tumors
The proportion of successes will be estimated by the number of successes(CR or PR) divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987). Complete Response (CR) is defined as disappearance of all target lesions and, if non target lesions exist, the disappearance of all non-target lesions and normalization of tumor maker level. At least 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum.
All treated patients that were evaluated for disease response
Posted
Number
percent of patients with response
Up to 48 weeks (12 courses)
ID
Title
Description
OG000
Phase 1 Dose Level 1
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG001
Phase 1 Dose Level 2
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Secondary
Overall Survival
The distribution of survival time for phase 2 patients will be estimated using the method of Kaplan-Meier.
Not Posted
Aug 2026
The time from registration to death due to any cause, assessed up to 5 years
Participants
Secondary
Progression Free Survival
The distribution of progression free survival will be estimated using the method of Kaplan-Meier.
Not Posted
Aug 2026
The time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
Participants
Secondary
Duration of Response
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a complete response or partial response to the earliest date progression is documented.
Not Posted
Aug 2026
Up to 5 years
Participants
Secondary
Time to Treatment Failure
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
Not Posted
Aug 2026
The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, assessed up to 5 years
Participants
Secondary
Adverse Events, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Not Posted
Up to 5 years
Participants
Time Frame
75 months
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1 Dose Level 1
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
0
3
0
3
3
3
EG001
Phase 1 Dose Level 10
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
2
6
2
6
6
6
EG002
Phase 1 Dose Level 11
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
0
5
3
5
5
5
EG003
Phase 1 Dose Level 12
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1
7
5
7
7
7
EG004
Phase 1 Dose Level 13
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1
3
2
3
3
3
EG005
Phase 2
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
2
31
12
31
29
31
EG006
Phase 1 Dose Level 2
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
0
3
0
3
3
3
EG007
Phase 1 Dose Level 3
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1
3
1
3
3
3
EG008
Phase 1 Dose Level 4
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1
4
1
4
4
4
EG009
Phase 1 Dose Level 5
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1
6
3
6
6
6
EG010
Phase 1 Dose Level 6
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1
7
2
7
7
7
EG011
Phase 1 Dose Level 7
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1
3
2
3
3
3
EG012
Phase 1 Dose Level 8
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
0
4
1
4
4
4
EG013
Phase 1 Dose Level 9
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1
3
0
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected5 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0092 events2 affected6 at risk
EG0100 events0 affected7 at risk
EG0112 events1 affected3 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected3 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Paroxysmal atrial tachycardia
Cardiac disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Colonic hemorrhage
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Colonic obstruction
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Colonic perforation
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Enterovesical fistula
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Ileal obstruction
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Rectal hemorrhage
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Fever
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Infections and infestations - Oth spec
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Lung infection
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Sepsis
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Creatinine increased
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
ECG QT corrected interval prolonged
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Investigations - Other, specify
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
White blood cell decreased
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Neoplasms benign, mal, uncpec - Oth spec
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Nervous system disorders - Oth spec
Nervous system disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Tremor
Nervous system disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Renal and urinary disorders - Oth spec
Renal and urinary disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Thromboembolic event
Vascular disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Vascular disorders - Other, specify
Vascular disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
MedDRA 12
Systematic Assessment
EG00040 events3 affected3 at risk
EG00136 events6 affected6 at risk
EG00222 events5 affected5 at risk
EG00353 events6 affected7 at risk
EG00421 events3 affected3 at risk
EG00545 events21 affected31 at risk
EG0065 events2 affected3 at risk
EG0075 events3 affected3 at risk
EG00811 events4 affected4 at risk
EG009112 events6 affected6 at risk
EG01034 events4 affected7 at risk
EG0116 events2 affected3 at risk
EG01233 events3 affected4 at risk
EG0135 events1 affected3 at risk
Blood and lymph sys disorders - Oth Spec
Blood and lymphatic system disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG00115 events4 affected6 at risk
EG0027 events2 affected5 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Cardiac disorders - Other, specify
Cardiac disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0024 events1 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Blurred vision
Eye disorders
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Dry eye
Eye disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Eye disorders - Other, specify
Eye disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected5 at risk
EG003
Keratitis
Eye disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Watering eyes
Eye disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events2 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG00011 events3 affected3 at risk
EG0014 events3 affected6 at risk
EG0026 events4 affected5 at risk
EG003
Anal hemorrhage
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events1 affected5 at risk
EG003
Bloating
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Colonic hemorrhage
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Colonic obstruction
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG00010 events1 affected3 at risk
EG00112 events3 affected6 at risk
EG0028 events2 affected5 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0005 events2 affected3 at risk
EG00112 events3 affected6 at risk
EG0026 events3 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Esophagitis
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Gastrointestinal disorders - Oth spec
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events2 affected6 at risk
EG00214 events2 affected5 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Gastroparesis
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hemorrhoids
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Mucositis oral
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG00021 events2 affected3 at risk
EG00124 events5 affected6 at risk
EG00210 events5 affected5 at risk
EG003
Rectal hemorrhage
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Rectal pain
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Stomach pain
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Upper gastrointestinal hemorrhage
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG00118 events5 affected6 at risk
EG0023 events3 affected5 at risk
EG003
Chills
General disorders
MedDRA 12
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected5 at risk
EG003
Edema limbs
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 12
Systematic Assessment
EG00027 events3 affected3 at risk
EG00117 events6 affected6 at risk
EG0026 events3 affected5 at risk
EG003
Fever
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Flu like symptoms
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Gait disturbance
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Gen disord and admin site conds-Oth spec
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0019 events2 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Malaise
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Neck edema
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events2 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Pain
General disorders
MedDRA 12
Systematic Assessment
EG0008 events1 affected3 at risk
EG0013 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Allergic reaction
Immune system disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Immune system disorders - Other, specify
Immune system disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0026 events1 affected5 at risk
EG003
Infections and infestations - Oth spec
Infections and infestations
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Pleural infection
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory infection
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events2 affected5 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Bruising
Injury, poisoning and procedural complications
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Activated partial throm time prolonged
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected6 at risk
EG0023 events2 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 12
Systematic Assessment
EG0003 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Alkaline phosphatase increased
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events3 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 12
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Creatinine increased
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events2 affected6 at risk
EG0020 events0 affected5 at risk
EG003
ECG QT corrected interval prolonged
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
INR increased
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Investigations - Other, specify
Investigations
MedDRA 12
Systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 12
Systematic Assessment
EG0006 events2 affected3 at risk
EG0015 events2 affected6 at risk
EG0029 events3 affected5 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 12
Systematic Assessment
EG00016 events1 affected3 at risk
EG00123 events6 affected6 at risk
EG00216 events3 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA 12
Systematic Assessment
EG00019 events1 affected3 at risk
EG00121 events6 affected6 at risk
EG00213 events3 affected5 at risk
EG003
Weight loss
Investigations
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
White blood cell decreased
Investigations
MedDRA 12
Systematic Assessment
EG00032 events1 affected3 at risk
EG00129 events6 affected6 at risk
EG00226 events4 affected5 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0005 events2 affected3 at risk
EG00118 events5 affected6 at risk
EG0024 events3 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0002 events2 affected3 at risk
EG0017 events4 affected6 at risk
EG0023 events3 affected5 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0003 events2 affected3 at risk
EG0012 events1 affected6 at risk
EG0025 events3 affected5 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hypermagnesemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Hypernatremia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hypertriglyceridemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG00015 events2 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected5 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Metabolism, nutrition disord - Oth spec
Metabolism and nutrition disorders
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG0018 events2 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG00011 events1 affected3 at risk
EG0017 events3 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Chest wall pain
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0006 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal, conn tissue - Oth spec
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events3 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG0017 events1 affected6 at risk
EG0020 events0 affected5 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12
Systematic Assessment
EG0001 events1 affected3 at risk
EG00114 events3 affected6 at risk
EG0022 events1 affected5 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
D004701
Endocrine Gland Neoplasms
D010049
Ovarian Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000071185
Pharmacogenomic Testing
D019772
Topotecan
C521013
veliparib
Ancestor Terms
ID
Term
D005820
Genetic Testing
D019411
Clinical Laboratory Techniques
D019937
Diagnostic Techniques and Procedures
D003933
Diagnosis
D008919
Investigative Techniques
D005821
Genetic Techniques
D033142
Genetic Services
D006296
Health Services
D005159
Health Care Facilities Workforce and Services
D003954
Diagnostic Services
D011314
Preventive Health Services
D002166
Camptothecin
D000470
Alkaloids
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
62.3
(51.5 to 73)
BG00460.3(57 to 64)
BG00559.7(52 to 70)
BG00650.3(45 to 59)
BG00752(50 to 54)
BG00854(46 to 66)
BG00956.2(49 to 64)
BG01056.2(56 to 57)
BG01150.1(41 to 65)
BG01255(50 to 63)
BG01360.8(53 to 69)
BG01458.0(50 to 66)
3
BG0034
BG0046
BG0056
BG0063
BG0074
BG0083
BG0096
BG0105
BG0117
BG0123
BG01331
BG01487
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0121
BG0131
BG0143
Not Hispanic or Latino
BG0003
BG0013
BG0023
BG0034
BG0046
BG0057
BG0063
BG0074
BG0083
BG0096
BG0105
BG0116
BG0122
BG01329
BG01484
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0131
BG0141
0
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0101
BG0110
BG0120
BG0130
BG0142
Asian
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0131
BG0142
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
White
BG0003
BG0013
BG0023
BG0033
BG0046
BG0056
BG0063
BG0074
BG0083
BG0096
BG0104
BG0117
BG0122
BG01330
BG01483
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
BG0130
BG0141
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
OG006
Phase 1 Dose Level 7
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG007
Phase 1 Dose Level 8
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG008
Phase 1 Dose Level 9
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG009
Phase 1 Dose Level 10
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG010
Phase 1 Dose Level 11
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG011
Phase 1 Dose Level 12
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG012
Phase 1 Dose Level 13
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
3
OG0046
OG0056
OG0063
OG0073
OG0083
OG0096
OG0103
OG0116
OG0123
0
OG0043
OG0052
OG0060
OG0070
OG0080
OG0091
OG0100
OG0111
OG0122
OG002
Phase 1 Dose Level 3
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG003
Phase 1 Dose Level 4
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG004
Phase 1 Dose Level 5
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG005
Phase 1 Dose Level 6
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG006
Phase 1 Dose Level 7
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG007
Phase 1 Dose Level 8
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG008
Phase 1 Dose Level 9
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG009
Phase 1 Dose Level 10
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG010
Phase 1 Dose Level 11
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG011
Phase 1 Dose Level 12
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG012
Phase 1 Dose Level 13
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OG013
Phase 2
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.