A Study of Oral Rucaparib in Patients With a Solid Tumor... | NCT01482715 | Trialant
NCT01482715
Sponsor
pharmaand GmbH
Status
Completed
Last Update Posted
Jun 9, 2023Actual
Enrollment
136Actual
Phase
Phase 1Phase 2
Conditions
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Advanced Solid Tumor With Evidence of Germline or Somatic BRCA
Interventions
Rucaparib
Countries
United States
Canada
Israel
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01482715
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CO-338-010
Secondary IDs
ID
Type
Description
Link
2011-004250-26
EudraCT Number
Brief Title
A Study of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II)
Official Title
A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Ovarian Cancer or Other Solid Tumor
Acronym
Not provided
Organization
pharmaand GmbHINDUSTRY
Status Module
Record Verification Date
Jun 2023
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
Nov 2011Actual
Primary Completion Date
Mar 2019Actual
Completion Date
May 2019Actual
First Submitted Date
Nov 22, 2011
First Submission Date that Met QC Criteria
Nov 29, 2011
First Posted Date
Nov 30, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
May 16, 2020
Results First Submitted that Met QC Criteria
Nov 12, 2020
Results First Posted Date
Dec 8, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 7, 2023
Last Update Posted Date
Jun 9, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
pharmaand GmbHINDUSTRY
Collaborators
Name
Class
Foundation Medicine
INDUSTRY
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
Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors.
Part 2A (Completed Enrollment) and Part 2B (Completed Enrollment) - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or somatic).
Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).
Detailed Description
Rucaparib (CO-338; formerly known as PF 01367338 and AG 14699) is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination [HR] DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies.
An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with BRCA1 or BRCA2 mutations. For this study, it is anticipated that rucaparib will promote cell death in the BRCA-deficient tumor cells of ovarian cancer patients with evidence of a germline mutation, thereby limiting tumor progression and providing therapeutic benefit.
Conditions Module
Conditions
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Advanced Solid Tumor With Evidence of Germline or Somatic BRCA
Keywords
gBRCA ovarian cancer
platinum sensitive
PARP Inhibitor
Rucaparib
CO-338
PF 01367338
AG 14699
BRCA1
BRCA2
platinum sensitive ovarian cancer
platinum sensitive gBRCA ovarian cancer
gynecological cancer
relapsed disease
homologous recombination deficiency
HRD
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
136Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 (Phase 1)
Experimental
Rucaparib 40, 80, 160, 300, 500 mg QD and 240, 360, 480, 600, 840 mg BID, for continuous 21-day cycles. Patients in Part 1 were initially treated in a Dose-escalation Evaluation Period (Cycle 1) and could then continue to receive treatment in an optional Treatment-extension Period (Cycle 2 and beyond).
Drug: Rucaparib
Part 2A (Phase 2)
Experimental
Rucaparib 600 mg BID for 21-day cycles.
Drug: Rucaparib
Part 2B (Phase 2)
Experimental
Rucaparib 600 mg BID for 21-day cycles.
Drug: Rucaparib
Part 3 (Phase 2)
Experimental
Rucaparib 600 mg BID for 21-day cycles. Patients also received a single administration of 600 mg rucaparib on both Day -7 and Day 1 for assessing the effect of food on PK.
Drug: Rucaparib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Rucaparib
Drug
Oral tablets administered daily with 8 oz (240 mL) of water on an empty stomach or with food; 21-day cycles of treatment. In Part 1, the initial dose level is 40 mg/day (once a day); doses and dosing frequency(e.g. twice a day or three times a day) will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. Patients enrolled in Part 2 and Part 3 will receive the RP2D for continuous 21-day treatment cycles until disease progression.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Response Rate Per RECIST Version 1.1 (Part 2)
The confirmed response rate by RECIST v1.1 is defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) on subsequent tumor assessment at least 28 days after first response documentation.
Time from first dose to date of progression, up to approximately 8 months
Number of Participants With a Dose Limiting Toxicity (DLT)
The number of Part 1 (Phase 1) patients who experienced dose limiting toxicities after one cycle (21 days) of study drug.
Cycle 1 Day 1 to Cycle 1 Day 21
PK Profile of Rucaparib - Cmax (Part 1)
Cmax = maximum concentration following administration of rucaparib
Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
PK Profile of Rucaparib - Tmax (Part 1)
Tmax = time to maximum concentration following administration of rucaparib
Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
PK Profile of Rucaparib - AUC Last (Part 1)
AUC last = Area under the plasma concentration-time curve from time 0 to the last recorded observation
Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
Secondary Outcomes
Measure
Description
Time Frame
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator (Part 2)
PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
Cycle 1 Day 1 to End of Treatment, up to approximately 51 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
The following eligibility criteria below pertain to patients enrolling into Part 2B of the study.
Inclusion Criteria:
Have a known deleterious BRCA mutation (gBRCA or sBRCA) (as determined by a local laboratory that has received an international or country-specific, quality standards certification)
Have evidence of measurable disease as defined by RECIST Version 1.1
Have sufficient archival FFPE tumor tissue available for planned analyses. Archival tissue from the most recently collected biopsy or debulking surgery should be provided, if available.
Have a histologically confirmed diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer
Have received at least three prior chemotherapy regimens and have relapsed disease confirmed by radiologic assessment
Exclusion Criteria:
Active second malignancy, i.e., patient known to have potentially fatal cancer present for which she may be (but not necessarily) currently receiving treatment
a. Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy was completed >6 months prior and/or bone marrow transplant (BMT) >2 years prior to first dose of rucaparib
Prior treatment with any PARP inhibitor.
Untreated or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks.
Received treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs 14 days prior to first dose of rucaparib and/or ongoing adverse effects from such treatment > NCI CTCAE Grade 1 (Grade 2 non-hematologic toxicity to most recent treatment may be permitted with prior advanced approval from Sponsor).
Hospitalization for bowel obstruction within 3 months prior to enrollment.
The study was conducted at 15 investigative sites in the United States (6 sites), United Kingdom (5 sites), Spain (1 site), Israel (2 sites), and Canada (1 site).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Rucaparib 40 mg QD (Part 1)
Rucaparib 40 mg once a day (QD) for continuous 21-day cycles
FG001
Rucaparib 80 mg QD (Part 1)
Rucaparib 80 mg once a day (QD) for continuous 21-day cycles
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
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 29, 2016
Mar 25, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Part 1 (Phase 1)
Part 2A (Phase 2)
Part 2B (Phase 2)
Part 3 (Phase 2)
CO-338; PF 01367338, AG 14699
Duration of Response Per RECIST Version 1.1 (Part 2)
Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first occurrence of a response until the first occurrence of PD per RECIST. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Any patients with an ongoing response were censored at the date of the last post-baseline scan.
Cycle 1 Day 1 to End of Treatment, up to approximately 48 months
Overall Survival (Part 2B)
Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death, due to any cause. Patients without a documented event of death will be censored on the date of their last visit.
Cycle 1 Day 1 to date of death, assessed up to 38 months
Food Effect on PK of Rucaparib - Cmax (Part 1 and Part 3)
Cmax = maximum concentration following administration of rucaparib. The effect of food on rucaparib PK parameters was assessed over a 24-hour period in blood samples from a subset of patients. Patients were given a single dose of 40 mg or 300 mg rucaparib (Part 1), or 600 mg rucaparib (Part 3) and were randomized to one of two sequences where they were either Fed (with a high-fat meal) or Fasted (without a high-fat meal) on Day -7 or Cycle 1 Day 1. On each day, patients underwent blood sampling for PK at the specified time points. The median Fed and Fasted Cmax values were calculated for each arm.
Day -7 to Cycle 1 Day 1, or approximately 7 days
Food Effect on PK of Rucaparib - Tmax (Part 1 and Part 3)
Tmax = time to maximum concentration following administration of rucaparib. The effect of food on rucaparib PK parameters was assessed over a 24-hour period in blood samples from a subset of patients. Patients were given a single dose of 40 mg or 300 mg rucaparib (Part 1), or 600 mg rucaparib (Part 3) and were randomized to one of two sequences where they were either Fed (with a high-fat meal) or Fasted (without a high-fat meal) on Day -7 or Cycle 1 Day 1. On each day, patients underwent blood sampling for PK at the specified time points. The median Fed and Fasted Tmax values were calculated for each arm.
Day -7 to Cycle 1 Day 1, or approximately 7 days
Food Effect on PK of Rucaparib - AUC Last (Part 1 and Part 3)
AUC last = Area under the plasma concentration-time curve from time 0 to the last recorded observation. The effect of food on rucaparib PK parameters was assessed over a 24-hour period in blood samples from a subset of patients. Patients were given a single dose of 40 mg or 300 mg rucaparib (Part 1), or 600 mg rucaparib (Part 3) and were randomized to one of two sequences where they were either Fed (with a high-fat meal) or Fasted (without a high-fat meal) on Day -7 or Cycle 1 Day 1. On each day, patients underwent blood sampling for PK at the specified time points. The median Fed and Fasted AUC last values were calculated for each arm.
Day -7 to Cycle 1 Day 1, or approximately 7 days
QTcF Value Change From Baseline (Part 1)
QTcF value change from baseline by daily dose corrected using Fridericia's method (QTcF). To evaluate the effects of rucaparib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Screening, on Cycle 1 Day -1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient.
Screening to End of Treatment, up to approximately 15 months
Sarasota
Florida
34232
United States
Dana-Farber Cancer Institute (Part 3 only)
Boston
Massachusetts
02215
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
Princess Margaret Cancer Centre
Toronto
Ontario
MSG 2M9
Canada
Sheba Medical Center
Ramat Gan
52621
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv
632394
Israel
Hospital Vall d'Hebron
Barcelona
8035
Spain
Guy's and St Thomas NHS Foundation Trust
London
England
SE1 9RT
United Kingdom
Royal Marsden NHS Foundation Trust
London
England
SW3 6JJ
United Kingdom
Imperial College Healthcare
London
England
W12 0HS
United Kingdom
Newcastle University
Newcastle upon Tyne
England
UK NE7
United Kingdom
Institution of Cancer Science, University of Glasgow Wolfson Wohl Cancer Research
Glasgow
Scotland
G61 1QH
United Kingdom
University College London Cancer Institute
London
WC1E 6BT
United Kingdom
Derived
Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.
Kristeleit RS, Oaknin A, Ray-Coquard I, Leary A, Balmana J, Drew Y, Oza AM, Shapira-Frommer R, Domchek SM, Cameron T, Maloney L, Goble S, Lorusso D, Ledermann JA, McNeish IA. Antitumor activity of the poly(ADP-ribose) polymerase inhibitor rucaparib as monotherapy in patients with platinum-sensitive, relapsed, BRCA-mutated, high-grade ovarian cancer, and an update on safety. Int J Gynecol Cancer. 2019 Nov;29(9):1396-1404. doi: 10.1136/ijgc-2019-000623.
Shapiro GI, Kristeleit RS, Burris HA, LoRusso P, Patel MR, Drew Y, Giordano H, Maloney L, Watkins S, Goble S, Jaw-Tsai S, Xiao JJ. Pharmacokinetic Study of Rucaparib in Patients With Advanced Solid Tumors. Clin Pharmacol Drug Dev. 2019 Jan;8(1):107-118. doi: 10.1002/cpdd.575. Epub 2018 May 25.
FG002
Rucaparib 160 mg QD (Part 1)
Rucaparib 160 mg once a day (QD) for continuous 21-day cycles
FG003
Rucaparib 300 mg QD (Part 1)
Rucaparib 300 mg once a day (QD) for continuous 21-day cycles
FG004
Rucaparib 500 mg QD (Part 1)
Rucaparib 500 mg once a day (QD) for continuous 21-day cycles
FG005
Rucaparib 240 mg BID (Part 1)
Rucaparib 240 mg twice a day (BID) for continuous 21-day cycles
FG006
Rucaparib 360 mg BID (Part 1)
Rucaparib 360 mg twice a day (BID) for continuous 21-day cycles
FG007
Rucaparib 480 mg BID (Part 1)
Rucaparib 480 mg twice a day (BID) for continuous 21-day cycles
FG008
Rucaparib 600 mg BID (Part 1)
Rucaparib 600 mg twice a day (BID) for continuous 21-day cycles
FG009
Rucaparib 840 mg BID (Part 1)
Rucaparib 840 mg twice a day (BID) for continuous 21-day cycles
FG010
Rucaparib 600 mg BID (Part 2A)
Rucaparib 600 mg twice a day (BID) for 21-day cycles
FG011
Rucaparib 600 mg BID (Part 2B)
Rucaparib 600 mg twice a day (BID) for 21-day cycles
FG012
Rucaparib 600 mg BID (Part 3)
Rucaparib 600 mg twice a day (BID) for 21-day cycles. Patients also received a single administration of 600 mg rucaparib on both Day -7 and Day 1 for assessing the effect of food on PK.
FG0006 subjects
FG0013 subjects
FG0024 subjects
FG0039 subjects
FG0044 subjects
FG0053 subjects
FG0068 subjects
FG0079 subjects
FG0087 subjects
FG0093 subjects
FG01042 subjects
FG01112 subjects
FG01226 subjects
COMPLETED
FG0006 subjects
FG0013 subjects
FG0024 subjects
FG0039 subjects
FG0044 subjects
FG0053 subjects
FG0068 subjects
FG0079 subjects
FG0087 subjects
FG0093 subjects
FG01042 subjects
FG01112 subjects
FG01226 subjects
NOT COMPLETED
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
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Rucaparib 40 mg QD (Part 1)
Rucaparib 40 mg QD for continuous 21-day cycles
BG001
Rucaparib 80 mg QD (Part 1)
Rucaparib 80 mg QD for continuous 21-day cycles
BG002
Rucaparib 160 mg QD (Part 1)
Rucaparib 160 mg QD for continuous 21-day cycles
BG003
Rucaparib 300 mg QD (Part 1)
Rucaparib 300 mg QD for continuous 21-day cycles
BG004
Rucaparib 500 mg QD (Part 1)
Rucaparib 500 mg QD for continuous 21-day cycles
BG005
Rucaparib 240 mg BID (Part 1)
Rucaparib 240 mg BID for continuous 21-day cycles
BG006
Rucaparib 360 mg BID (Part 1)
Rucaparib 360 mg BID for continuous 21-day cycles
BG007
Rucaparib 480 mg BID (Part 1)
Rucaparib 480 mg BID for continuous 21-day cycles
BG008
Rucaparib 600 mg BID (Part 1)
Rucaparib 600 mg BID for continuous 21-day cycles
BG009
Rucaparib 840 mg BID (Part 1)
Rucaparib 840 mg BID for continuous 21-day cycles
BG010
Rucaparib 600 mg BID (Part 2A)
Rucaparib 600 mg BID for continuous 21-day cycles
BG011
Rucaparib 600 mg BID (Part 2B)
Rucaparib 600 mg BID for continuous 21-day cycles
BG012
Rucaparib 600 mg BID (Part 3)
Rucaparib 600 mg BID for continuous 21-day cycles
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0013
BG0024
BG0039
BG0044
BG0053
BG0068
BG0079
BG0087
BG0093
BG01042
BG01112
BG01226
BG013136
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00063.5(45.0 to 71.0)
BG00146.0(41.0 to 49.0)
BG00252.0(37.0 to 56.0)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0013
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
Overall Response Rate Per RECIST Version 1.1 (Part 2)
The confirmed response rate by RECIST v1.1 is defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) on subsequent tumor assessment at least 28 days after first response documentation.
Efficacy-Evaluable Population - all Part 2 patients who met eligibility criteria, received at least 1 dose of rucaparib, had measurable tumor lesions at baseline, and had at least 1 post-baseline disease assessment. 2 patients in Part 2A discontinued treatment due to an AE and did not have a post-baseline disease assessment.
Posted
Count of Participants
Participants
Time from first dose to date of progression, up to approximately 8 months
ID
Title
Description
OG000
Rucaparib 600 mg BID (Part 2A)
Rucaparib 600 mg BID for 21-day cycles
OG001
Rucaparib 600 mg BID (Part 2B)
Rucaparib 600 mg BID for 21-day cycles
Units
Counts
Participants
OG00040
OG00112
Title
Denominators
Categories
Title
Measurements
OG00025
OG0017
Primary
Number of Participants With a Dose Limiting Toxicity (DLT)
The number of Part 1 (Phase 1) patients who experienced dose limiting toxicities after one cycle (21 days) of study drug.
DLT-evaluable population - all patients enrolled into Part 1 of the study who received at least 17 complete days of rucaparib and completed Cycle 1 of treatment, or who experienced a DLT in Cycle 1.
Posted
Count of Participants
Participants
Cycle 1 Day 1 to Cycle 1 Day 21
ID
Title
Description
OG000
Rucaparib 40 mg QD (Part 1)
Rucaparib 40 mg once a day (QD)
OG001
Rucaparib 80 mg QD (Part 1)
Rucaparib 80 mg once a day (QD)
OG002
Rucaparib 160 mg QD (Part 1)
Rucaparib 160 mg once a day (QD)
OG003
Rucaparib 300 mg QD (Part 1)
Rucaparib 300 mg once a day (QD)
OG004
Rucaparib 500 mg QD (Part 1)
Primary
PK Profile of Rucaparib - Cmax (Part 1)
Cmax = maximum concentration following administration of rucaparib
PK-evaluable population - all patients enrolled into Part 1 of the study who received at least one dose of rucaparib and had adequate PK assessments drawn for determination of the PK profile. For some arms, the number analyzed at Day 1 and Day 15 differs from the overall number based on number of evaluable samples collected at each time point.
Posted
Median
Full Range
ng/mL
Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
ID
Title
Description
OG000
Rucaparib 40 mg QD
Rucaparib 40 mg once a day (QD)
OG001
Rucaparib 80 mg QD
Rucaparib 80 mg once a day (QD)
OG002
Rucaparib 160 mg QD
Rucaparib 160 mg once a day (QD)
OG003
Rucaparib 300 mg QD
Rucaparib 300 mg once a day (QD)
OG004
Primary
PK Profile of Rucaparib - Tmax (Part 1)
Tmax = time to maximum concentration following administration of rucaparib
PK-evaluable population - all patients enrolled into Part 1 of the study who received at least one dose of rucaparib and had adequate PK assessments drawn for determination of the PK profile. For some arms, the number analyzed at Day 1 and Day 15 differs from the overall number based on number of evaluable samples collected at each time point.
Posted
Median
Full Range
hr
Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
ID
Title
Description
OG000
Rucaparib 40 mg QD
Rucaparib 40 mg once a day (QD)
OG001
Rucaparib 80 mg QD
Rucaparib 80 mg once a day (QD)
OG002
Rucaparib 160 mg QD
Rucaparib 160 mg once a day (QD)
OG003
Rucaparib 300 mg QD
Rucaparib 300 mg once a day (QD)
OG004
Primary
PK Profile of Rucaparib - AUC Last (Part 1)
AUC last = Area under the plasma concentration-time curve from time 0 to the last recorded observation
PK-evaluable population - all patients enrolled into Part 1 of the study who received at least one dose of rucaparib and had adequate PK assessments drawn for determination of the PK profile. For some arms, the number analyzed at Day 1 and Day 15 differs from the overall number based on number of evaluable samples collected at each time point.
Posted
Median
Full Range
hr*ng/mL
Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
ID
Title
Description
OG000
Rucaparib 40 mg QD
Rucaparib 40 mg once a day (QD)
OG001
Rucaparib 80 mg QD
Rucaparib 80 mg once a day (QD)
OG002
Rucaparib 160 mg QD
Rucaparib 160 mg once a day (QD)
OG003
Rucaparib 300 mg QD
Rucaparib 300 mg once a day (QD)
Secondary
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator (Part 2)
PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
Safety population: Consist of all Part 2 patients who received at least one dose of rucaparib
Posted
Median
95% Confidence Interval
Days
Cycle 1 Day 1 to End of Treatment, up to approximately 51 months
ID
Title
Description
OG000
Rucaparib 600 mg BID (Part 2A)
Rucaparib 600 mg BID for 21-day cycles
OG001
Rucaparib 600 mg BID (Part 2B)
Rucaparib 600 mg BID for 21-day cycles
Units
Counts
Participants
OG000
Secondary
Duration of Response Per RECIST Version 1.1 (Part 2)
Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first occurrence of a response until the first occurrence of PD per RECIST. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Any patients with an ongoing response were censored at the date of the last post-baseline scan.
Safety population - all Part 2 patients with confirmed response per investigator.
Posted
Median
95% Confidence Interval
Days
Cycle 1 Day 1 to End of Treatment, up to approximately 48 months
ID
Title
Description
OG000
Rucaparib 600 mg BID (Part 2A)
Rucaparib 600 mg BID for 21-day cycles
OG001
Rucaparib 600 mg BID (Part 2B)
Rucaparib 600 mg BID for 21-day cycles
Units
Counts
Participants
OG000
Secondary
Overall Survival (Part 2B)
Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death, due to any cause. Patients without a documented event of death will be censored on the date of their last visit.
Safety population: Consist of all Part 2B patients who received at least one dose of rucaparib
Posted
Median
95% Confidence Interval
Days
Cycle 1 Day 1 to date of death, assessed up to 38 months
ID
Title
Description
OG000
Rucaparib 600 mg BID (Part 2B)
Rucaparib 600 mg BID for 21-day cycles
Units
Counts
Participants
OG000
Secondary
Food Effect on PK of Rucaparib - Cmax (Part 1 and Part 3)
Cmax = maximum concentration following administration of rucaparib. The effect of food on rucaparib PK parameters was assessed over a 24-hour period in blood samples from a subset of patients. Patients were given a single dose of 40 mg or 300 mg rucaparib (Part 1), or 600 mg rucaparib (Part 3) and were randomized to one of two sequences where they were either Fed (with a high-fat meal) or Fasted (without a high-fat meal) on Day -7 or Cycle 1 Day 1. On each day, patients underwent blood sampling for PK at the specified time points. The median Fed and Fasted Cmax values were calculated for each arm.
A subset of patients treated with either 40 mg, 300 mg, or 600 mg rucaparib
Posted
Median
Full Range
ng/mL
Day -7 to Cycle 1 Day 1, or approximately 7 days
ID
Title
Description
OG000
Rucaparib 40 mg QD
Rucaparib 40 mg single dose
OG001
Rucaparib 300 mg QD
Rucaparib 300 mg single dose
OG002
Rucaparib 600 mg BID
Rucaparib 600 mg single dose
Secondary
Food Effect on PK of Rucaparib - Tmax (Part 1 and Part 3)
Tmax = time to maximum concentration following administration of rucaparib. The effect of food on rucaparib PK parameters was assessed over a 24-hour period in blood samples from a subset of patients. Patients were given a single dose of 40 mg or 300 mg rucaparib (Part 1), or 600 mg rucaparib (Part 3) and were randomized to one of two sequences where they were either Fed (with a high-fat meal) or Fasted (without a high-fat meal) on Day -7 or Cycle 1 Day 1. On each day, patients underwent blood sampling for PK at the specified time points. The median Fed and Fasted Tmax values were calculated for each arm.
A subset of patients treated with either 40 mg, 300 mg, or 600 mg rucaparib
Posted
Median
Full Range
hr
Day -7 to Cycle 1 Day 1, or approximately 7 days
ID
Title
Description
OG000
Rucaparib 40 mg QD
Rucaparib 40 mg single dose
OG001
Rucaparib 300 mg QD
Rucaparib 300 mg single dose
OG002
Rucaparib 600 mg BID
Rucaparib 600 mg single dose
Secondary
Food Effect on PK of Rucaparib - AUC Last (Part 1 and Part 3)
AUC last = Area under the plasma concentration-time curve from time 0 to the last recorded observation. The effect of food on rucaparib PK parameters was assessed over a 24-hour period in blood samples from a subset of patients. Patients were given a single dose of 40 mg or 300 mg rucaparib (Part 1), or 600 mg rucaparib (Part 3) and were randomized to one of two sequences where they were either Fed (with a high-fat meal) or Fasted (without a high-fat meal) on Day -7 or Cycle 1 Day 1. On each day, patients underwent blood sampling for PK at the specified time points. The median Fed and Fasted AUC last values were calculated for each arm.
A subset of patients treated with either 40 mg, 300 mg, or 600 mg rucaparib. For the 40 mg and 300 mg arms, the number analyzed at Day 1 and Day 15 differs from the overall number based on number of evaluable samples collected at each time point.
Posted
Median
Full Range
hr*ng/mL
Day -7 to Cycle 1 Day 1, or approximately 7 days
ID
Title
Description
OG000
Rucaparib 40 mg QD
Rucaparib 40 mg single dose
OG001
Rucaparib 300 mg QD
Rucaparib 300 mg single dose
OG002
Rucaparib 600 mg BID
Secondary
QTcF Value Change From Baseline (Part 1)
QTcF value change from baseline by daily dose corrected using Fridericia's method (QTcF). To evaluate the effects of rucaparib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Screening, on Cycle 1 Day -1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient.
Safety population: Consist of all Part 1 patients who received at least one dose of rucaparib. One patient in the 40 mg dose group had no Baseline evaluation and was excluded from analyses of change from Baseline.
Posted
Count of Participants
Participants
Screening to End of Treatment, up to approximately 15 months
ID
Title
Description
OG000
Rucaparib 40 mg QD
Rucaparib 40 mg once a day (QD)
OG001
Rucaparib 80 mg QD
Rucaparib 80 mg once a day (QD)
OG002
Rucaparib 160 mg QD
Rucaparib 160 mg once a day (QD)
OG003
Time Frame
Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug. The first patient was dosed in 2012 through study completion in 2017, with an average treatment duration of 173.9 days in Part 1, 331.1 days in Part 2A, 348.2 days in Part 2B, and 198.8 days in Part 3.
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
Rucaparib 40 mg QD (Part 1)
Rucaparib 40 mg QD for 21-day cycles
0
6
2
6
6
6
EG001
Rucaparib 80 mg QD (Part 1)
Rucaparib 80 mg QD for 21-day cycles
0
3
1
3
3
3
EG002
Rucaparib 160 mg QD (Part 1)
Rucaparib 160 mg QD for 21-day cycles
1
4
3
4
4
4
EG003
Rucaparib 300 mg QD (Part 1)
Rucaparib 300 mg QD for 21-day cycles
1
9
4
9
9
9
EG004
Rucaparib 500 mg QD (Part 1)
Rucaparib 500 mg QD for 21-day cycles
0
4
0
4
4
4
EG005
Rucaparib 240 mg BID (Part 1)
Rucaparib 240 mg BID for 21-day cycles
1
3
2
3
3
3
EG006
Rucaparib 360 mg BID (Part 1)
Rucaparib 360 mg BID for 21-day cycles
0
8
3
8
8
8
EG007
Rucaparib 480 mg BID (Part 1)
Rucaparib 480 mg BID for 21-day cycles
1
9
4
9
8
9
EG008
Rucaparib 600 mg BID (Part 1)
Rucaparib 600 mg BID for 21-day cycles
0
7
1
7
7
7
EG009
Rucaparib 840 mg BID (Part 1)
Rucaparib 840 mg BID for 21-day cycles
0
3
1
3
3
3
EG010
Rucaparib 600 mg BID (Part 2A)
Rucaparib 600 mg BID for 21-day cycles
4
42
19
42
41
42
EG011
Rucaparib 600 mg BID (Part 2B)
Rucaparib 600 mg BID for 21-day cycles
1
12
3
12
12
12
EG012
Rucaparib 600 mg BID (Part 3)
Rucaparib 600 mg BID for 21-day cycles
4
26
9
26
26
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected9 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected8 at risk
EG0070 affected9 at risk
EG0081 affected7 at risk
EG0090 affected3 at risk
EG0103 affected42 at risk
EG0110 affected12 at risk
EG0120 affected26 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Generalised oedema
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Epiglottiis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Influenza
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urinary tract stoma complication
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
B-cell type acute leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Myodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Seizure
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vaginal fistula
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0021 affected4 at risk
EG0033 affected9 at risk
EG0041 affected4 at risk
EG0050 affected3 at risk
EG0064 affected8 at risk
EG0073 affected9 at risk
EG0084 affected7 at risk
EG0091 affected3 at risk
EG01030 affected42 at risk
EG0118 affected12 at risk
EG0126 affected26 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0022 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0003 affected6 at risk
EG0011 affected3 at risk
EG0023 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Tooth disorder
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected3 at risk
EG0023 affected4 at risk
EG003
Asthenia
General disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Axillary pain
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Chest pain
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Chills
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Early satiety
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Influenza like illness
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Injection site bruising
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Malaise
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Peripheral swelling
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Ear infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Viral upper respiratory infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood potassium increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood urea increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Transaminases increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0003 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0021 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Tremor
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hot flush
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Macular degeneration
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Mydriasis
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Visual impairment
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Tooth erosion
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Catheter site inflammation
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Catheter site pain
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Chest discomfort
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Local swelling
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Nodule
General disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Suprapubic pain
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Ulcer
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Furuncle
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Influenza
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Oral infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Skin candida
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Skin infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection enterococcal
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Wound infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood urea nitrogen/creatinine ratio increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Heart rate increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Neutrophil count increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Bone lesion
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Extremity contracture
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Seizure
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Sensory loss
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Mental fatigue
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Obstructive uropathy
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vaginal fistula
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Telangiectasia
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Flushing
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected4 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
Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
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
D005184
Fallopian Tube Diseases
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C531549
rucaparib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
48.0
(41.0 to 63.0)
BG00429.5(21.0 to 56.0)
BG00564.0(62.0 to 68.0)
BG00649.5(32.0 to 71.0)
BG00746.0(28.0 to 70.0)
BG00852.0(35.0 to 57.0)
BG00955.0(42.0 to 59.0)
BG01056.5(42.0 to 84.0)
BG01157.5(46.0 to 72.0)
BG01259.5(39.0 to 79.0)
BG01357.0(21.0 to 84.0)
4
BG0039
BG0042
BG0052
BG0067
BG0079
BG0087
BG0092
BG01042
BG01112
BG01221
BG013126
Male
BG0000
BG0010
BG0020
BG0030
BG0042
BG0051
BG0061
BG0070
BG0080
BG0091
BG0100
BG0110
BG0125
BG01310
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0071
BG0080
BG0091
BG0103
BG0110
BG0121
BG0137
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
Black or African American
BG0000
BG0010
BG0020
BG0032
BG0041
BG0050
BG0061
BG0070
BG0080
BG0090
BG0103
BG0110
BG0122
BG0139
White
BG0006
BG0013
BG0024
BG0037
BG0043
BG0053
BG0066
BG0078
BG0087
BG0092
BG01035
BG01111
BG01222
BG013117
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
BG0110
BG0121
BG0132
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0120
BG0131
Rucaparib 500 mg once a day (QD)
OG005
Rucaparib 240 mg BID (Part 1)
Rucaparib 240 mg twice a day (BID)
OG006
Rucaparib 360 mg BID (Part 1)
Rucaparib 360 mg twice a day (BID)
OG007
Rucaparib 480 mg BID (Part 1)
Rucaparib 480 mg twice a day (BID)
OG008
Rucaparib 600 mg BID (Part 1)
Rucaparib 600 mg twice a day (BID)
OG009
Rucaparib 840 mg BID (Part 1)
Rucaparib 840 mg twice a day (BID)
Units
Counts
Participants
OG0006
OG0013
OG0024
OG0039
OG0044
OG0053
OG0068
OG0079
OG0087
OG0093
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
RP2D
600
2-Sided
Other
A MTD was not established based on observation of DLTs in Cycle 1 of treatment. The 600 mg BID dose was considered to be the maximum dose with an acceptable toxicity profile that could be continuously administered to patients and was selected as the recommended Phase 2 dose (RP2D).
Rucaparib 500 mg QD
Rucaparib 500 mg once a day (QD)
OG005
Rucaparib 240 mg BID
Rucaparib 240 mg twice a day (BID)
OG006
Rucaparib 360 mg BID
Rucaparib 360 mg twice a day (BID)
OG007
Rucaparib 480 mg BID
Rucaparib 480 mg twice a day (BID)
OG008
Rucaparib 600 mg BID
Rucaparib 600 mg twice a day (BID)
OG009
Rucaparib 840 mg BID
Rucaparib 840 mg twice a day (BID)
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0053
OG0068
OG0079
OG0087
OG0093
Title
Denominators
Categories
Day 1 Cmax
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0068
ParticipantsOG0079
ParticipantsOG0087
ParticipantsOG0093
Title
Measurements
OG000120(98.9 to 168)
OG001119(65.7 to 158)
OG002255(107 to 426)
OG003
Day 15 Cmax
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Rucaparib 500 mg QD
Rucaparib 500 mg once a day (QD)
OG005
Rucaparib 240 mg BID
Rucaparib 240 mg twice a day (BID)
OG006
Rucaparib 360 mg BID
Rucaparib 360 mg twice a day (BID)
OG007
Rucaparib 480 mg BID
Rucaparib 480 mg twice a day (BID)
OG008
Rucaparib 600 mg BID
Rucaparib 600 mg twice a day (BID)
OG009
Rucaparib 840 mg BID
Rucaparib 840 mg twice a day (BID)
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0053
OG0068
OG0079
OG0087
OG0093
Title
Denominators
Categories
Day 1 Tmax
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0068
ParticipantsOG0079
ParticipantsOG0087
ParticipantsOG0093
Title
Measurements
OG0002.5(1 to 4)
OG0011.5(1 to 2.5)
OG0024(4 to 6.05)
OG003
Day 15 Tmax
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
OG004
Rucaparib 500 mg QD
Rucaparib 500 mg once a day (QD)
OG005
Rucaparib 240 mg BID
Rucaparib 240 mg twice a day (BID)
OG006
Rucaparib 360 mg BID
Rucaparib 360 mg twice a day (BID)
OG007
Rucaparib 480 mg BID
Rucaparib 480 mg twice a day (BID)
OG008
Rucaparib 600 mg BID
Rucaparib 600 mg twice a day (BID)
OG009
Rucaparib 840 mg BID
Rucaparib 840 mg twice a day (BID)
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0053
OG0068
OG0079
OG0087
OG0093
Title
Denominators
Categories
Day 1 AUC last
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0068
ParticipantsOG0079
ParticipantsOG0087
ParticipantsOG0093
Title
Measurements
OG000915(850 to 981)
OG001916(555 to 930)
OG0022730(1520 to 5230)
OG003
Day 15 AUC last
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
42
OG00112
Title
Denominators
Categories
Title
Measurements
OG000260(203 to 373)
OG001280(40 to 551)
25
OG0017
Title
Denominators
Categories
Title
Measurements
OG000270(170 to 393)
OG001318(106 to 497)
12
Title
Denominators
Categories
Title
Measurements
OG000764(166 to NA)The upper confidence of the median is not reached due to not enough death events.