Study of RP-3500 (Camonsertib) With Niraparib or Olaparib... | NCT04972110 | Trialant
NCT04972110
Sponsor
Repare Therapeutics
Status
Terminated
Last Update Posted
Oct 30, 2025Actual
Enrollment
156Actual
Phase
Phase 1Phase 2
Conditions
Advanced Solid Tumor, Adult
Interventions
RP-3500 (camonsertib)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04972110
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RP-3500-03
Secondary IDs
Not provided
Brief Title
Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors
Official Title
Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients With Molecularly Selected Cancers (ATTACC)
Acronym
ATTACC
Organization
Repare TherapeuticsINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decided to terminate study early therefore, the Phase 2 portion was not conducted
Expanded Access Info
No
Start Date
Jul 21, 2021Actual
Primary Completion Date
Nov 13, 2024Actual
Completion Date
Nov 13, 2024Actual
First Submitted Date
Jul 2, 2021
First Submission Date that Met QC Criteria
Jul 16, 2021
First Posted Date
Jul 22, 2021Actual
Results Waived
Not provided
Results First Submitted Date
May 29, 2025
Results First Submitted that Met QC Criteria
Oct 1, 2025
Results First Posted Date
Oct 30, 2025Actual
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
Oct 1, 2025
Last Update Posted Date
Oct 30, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Repare TherapeuticsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose of this study is to assess the safety and tolerability of niraparib or olaparib in combination with RP-3500 (camonsertib), in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 (camonsertib) in combination with niraparib or olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.
Detailed Description
This is a first-in-human Phase 1b/2, multi-center, open-label, dose-escalation and expansion study to:
Evaluate the safety profile and MTD of RP-3500 (camonsertib) when administered orally in combination with niraparib or olaparib to establish the recommended Phase 2 dose and schedule.
Characterize the PK profile of RP-3500 (camonsertib) in combination with niraparib or olaparib
Assess anti-tumor activity associated with RP-3500 (camonsertib) in combination with niraparib or olaparib
Examine biomarker responses and establish a correlation with RP-3500 (camonsertib) treatment in combination with niraparib or olaparib.
After the RP2D and schedule is determined, expansion cohort(s) for RP-3500 (camonsertib) in combination with niraparib or olaparib will be enrolled to study the anti-tumor effect, and further examine the safety, PK, and pharmacodynamic (PD).
Sponsor decided to terminate study early therefore, the Phase 2 expansion was not conducted
Conditions Module
Conditions
Advanced Solid Tumor, Adult
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
156Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase Ib Dose Escalation
Experimental
Multiple dose levels of RP-3500 (camonsertib) for oral administration in combination with niraparib and/or Multiple dose levels of RP-3500 (camonsertib) for oral administration in combination with olaparib
RP-3500 (camonsertib, ATR inhibitor) in combination with niraparib or olaparib (PARP inhibitors)
Phase 2 Expansion Cohorts
Phase Ib Dose Escalation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Determine the Safety and Tolerability of Niraparib or Olaparib in Combination With RP-3500 in Patients With Molecularly Selected Solid Tumors
Treatment Related Treatment-Emergent Adverse Events (TRAE) with ≥3 CTCAE Grade
Start of treatment to 30 days post last dose, up to 23.7 months
Define the Recommended Phase 2 Dose (RP2D) of RP-3500 in Combination With Niraparib or Olaparib in Patients With Molecularly Selected Solid Tumors
Frequency of DLTs during the DLT observation period
During 21 days (one cycle) from the initiation of the study treatment
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female and ≥18 years-of-age at the time of signature of the informed consent
Confirmed advanced solid tumors resistant or refractory to standard treatment
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Evaluable disease as per RECIST v1.1
Next generation sequencing (NGS) report obtained in CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarkers.
Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible
Acceptable hematologic and organ function at screening
Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug.
Ability to swallow and retain oral medications.
Exclusion Criteria:
Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor.
Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 10 days or 5 half-lives (whichever is longer), prior to first dose of study drug.
Use of radiotherapy (except for palliative reasons) within 7 days prior to first dose of study drug.
History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
No other anticancer therapy is to be permitted while the patient is receiving study treatment.
Major surgery ≤28 days or minor surgical procedures ≤7 days prior to first study treatment dose.
Uncontrolled, symptomatic brain metastases.
Uncontrolled high blood pressure
History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
Presence of other known active invasive cancers.
Pregnant or breastfeeding women.
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the study protocol and/or follow-up procedures outlined in the protocol.
Silverman IM, Schonhoft JD, Herzberg B, Yablonovitch A, Lagow E, Fiaux PC, Safabakhsh P, Sethuraman S, Ulanet D, Yang J, Kim I, Basciano P, Cecchini M, Lee E, Lheureux S, Fontana E, Carneiro BA, Reis-Filho JS, Yap TA, Zinda M, Rosen EY, Rimkunas V. Genomic and Epigenomic ctDNA Profiling in Liquid Biopsies from Heavily Pretreated Patients with DNA Damage Response-Deficient Tumors. Clin Cancer Res. 2025 Oct 1;31(19):4136-4149. doi: 10.1158/1078-0432.CCR-25-1248.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1: 50mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD (once a day) orally in combination with 100 mg niraparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
FG002
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
FG003
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, 2 weeks on/1 week off
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 2 weeks on and 1 week off (21 day cycle)
FG004
Arm 1: 70mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
70 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
FG005
Arm 2: 50mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 150 mg olaparib taken BID (twice a day) orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
FG006
Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
FG007
Arm 2: 50mg QD camonsertib + 200 mg QD olaparib, 3d on/4 d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 200 mg olaparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
FG008
Arm 2: 80mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly
80 mg RP-3500 (camonsertib) taken QD orally in combination with 150 mg olaparib taken BID orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
50 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
FG010
Arm 2: 80mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, 2w on/1w off
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 2 days on and 5 days off schedule for 2 weeks on and 1 week off (21 day cycle)
FG0009 subjects
FG00124 subjects
FG0023 subjects
FG00323 subjects
FG0048 subjects
FG0057 subjects
FG00619 subjects
FG0075 subjects
FG0083 subjects
FG00926 subjects
FG01029 subjects
COMPLETED
FG0001 subjects
FG0014 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0008 subjects
FG00120 subjects
FG0022 subjects
FG00323 subjects
FG0048 subjects
FG0057 subjects
FG00618 subjects
FG0074 subjects
FG0082 subjects
FG00926 subjects
FG01029 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1: 50mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD (once a day) orally in combination with 100 mg niraparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
BG002
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
BG003
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, 2 weeks on/1 week off
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 2 weeks on and 1 week off (21 day cycle)
BG004
Arm 1: 70mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
70 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
BG005
Arm 2: 50mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 150 mg olaparib taken BID (twice a day) orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
BG006
Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
BG007
Arm 2: 50mg QD camonsertib + 200 mg QD olaparib, 3d on/4 d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 200 mg olaparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
BG008
Arm 2: 80mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly
80 mg RP-3500 (camonsertib) taken QD orally in combination with 150 mg olaparib taken BID orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
50 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
BG010
Arm 2: 80mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, 2w on/1w off
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 2 days on and 5 days off schedule for 2 weeks on and 1 week off (21 day cycle)
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG00124
BG0023
BG00323
BG0048
BG0057
BG00619
BG0075
BG0083
BG00926
BG01029
BG011156
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Mean
Standard Deviation
years
Title
Denominators
Categories
Age
Title
Measurements
BG00060.9± 13.51
BG00161.7± 7.70
BG00261.7± 15.18
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG00120
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
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
Determine the Safety and Tolerability of Niraparib or Olaparib in Combination With RP-3500 in Patients With Molecularly Selected Solid Tumors
Treatment Related Treatment-Emergent Adverse Events (TRAE) with ≥3 CTCAE Grade
Posted
Count of Participants
Participants
Start of treatment to 30 days post last dose, up to 23.7 months
ID
Title
Description
OG000
Arm 1: 50mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD (once a day) orally in combination with 100 mg niraparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
OG002
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
OG003
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, 2 weeks on/1 week off
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 2 weeks on and 1 week off (21 day cycle)
OG004
Arm 1: 70mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
70 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
OG005
Arm 2: 50mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 150 mg olaparib taken BID (twice a day) orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
OG006
Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
OG007
Arm 2: 50mg QD camonsertib + 200 mg QD olaparib, 3d on/4 d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 200 mg olaparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
OG008
Arm 2: 80mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly
80 mg RP-3500 (camonsertib) taken QD orally in combination with 150 mg olaparib taken BID orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
50 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
OG010
Arm 2: 80mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, 2w on/1w off
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 2 days on and 5 days off schedule for 2 weeks on and 1 week off (21 day cycle)
Units
Counts
Participants
OG0009
OG00124
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0008
OG00120
OG0023
OG003
Primary
Define the Recommended Phase 2 Dose (RP2D) of RP-3500 in Combination With Niraparib or Olaparib in Patients With Molecularly Selected Solid Tumors
Frequency of DLTs during the DLT observation period
Posted
Count of Participants
Participants
During 21 days (one cycle) from the initiation of the study treatment
ID
Title
Description
OG000
Arm 1: 50mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD (once a day) orally in combination with 100 mg niraparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
OG002
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
OG003
Time Frame
Start of treatment to 30 days post lase dose, up to 34.7 months for Serious adverse events; Start of treatment to 30 days post last dose, up to 23.7 months for other adverse events
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
Arm 1: 50mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD (once a day) orally in combination with 100 mg niraparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
10
24
8
24
24
24
EG002
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
0
3
2
3
3
3
EG003
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, 2 weeks on/1 week off
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 2 weeks on and 1 week off (21 day cycle)
70 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
1
8
3
8
8
8
EG005
Arm 2: 50mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 150 mg olaparib taken BID (twice a day) orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
4
7
1
7
7
7
EG006
Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
10
19
11
19
19
19
EG007
Arm 2: 50mg QD camonsertib + 200 mg QD olaparib, 3d on/4 d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 200 mg olaparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
1
5
2
5
5
5
EG008
Arm 2: 80mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly
80 mg RP-3500 (camonsertib) taken QD orally in combination with 150 mg olaparib taken BID orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
50 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
6
26
8
26
26
26
EG010
Arm 2: 80mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, 2w on/1w off
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 2 days on and 5 days off schedule for 2 weeks on and 1 week off (21 day cycle)
5
29
8
29
27
29
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG0030 affected23 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0062 affected19 at risk
EG0070 affected5 at risk
EG0080 affected3 at risk
EG0091 affected26 at risk
EG0100 affected29 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased/ Neutropenia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased/ Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0021 affected3 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Pyrexia
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Wound infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Embolism
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0008 affected9 at risk
EG00120 affected24 at risk
EG0023 affected3 at risk
EG00315 affected23 at risk
EG0046 affected8 at risk
EG0056 affected7 at risk
EG00617 affected19 at risk
EG0074 affected5 at risk
EG0083 affected3 at risk
EG00924 affected26 at risk
EG01019 affected29 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected9 at risk
EG0014 affected24 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased/ Neutropenia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0004 affected9 at risk
EG00115 affected24 at risk
EG0023 affected3 at risk
EG003
Platelet count decreased/ Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0003 affected9 at risk
EG00110 affected24 at risk
EG0023 affected3 at risk
EG003
WBC count decreased/ Leukopenia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0003 affected9 at risk
EG0018 affected24 at risk
EG0021 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Cardiac discomfort
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0014 affected24 at risk
EG0020 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Eye pain
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Eye swelling
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0013 affected24 at risk
EG0021 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected9 at risk
EG0014 affected24 at risk
EG0020 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Change of bowel habit
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected9 at risk
EG00110 affected24 at risk
EG0021 affected3 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0003 affected9 at risk
EG0017 affected24 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0013 affected24 at risk
EG0020 affected3 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal wall thickening
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0021 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Large intestinal ulcer
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0005 affected9 at risk
EG0019 affected24 at risk
EG0020 affected3 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Rectal ulcer
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected9 at risk
EG0018 affected24 at risk
EG0021 affected3 at risk
EG003
Asthenia
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Axillary pain
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Chest discomfort
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Crying
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Deformity
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Early satiety
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Face oedema
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0004 affected9 at risk
EG00117 affected24 at risk
EG0022 affected3 at risk
EG003
Influenza like illness
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Localised oedema
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected9 at risk
EG0013 affected24 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Peripheral swelling
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0022 affected3 at risk
EG003
Suprapubic pain
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Swelling face
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Temperature intolerance
General disorders and administration site conditions
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0015 affected24 at risk
EG0021 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Ludwig angina
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0021 affected3 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0013 affected24 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected9 at risk
EG0013 affected24 at risk
EG0021 affected3 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Wound infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0013 affected24 at risk
EG0020 affected3 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Incision site inflammation
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Post procedural bile leak
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Urostomy complication
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0021 affected3 at risk
EG003
Blood albumin increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Blood chloride decreased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Blood urea increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Heart rate increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Neutrophil count increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Nitrite urine present
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Protein total decreased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Thyroxine increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Urine analysis abnormal
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Weight increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
White blood cells urine positive
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0015 affected24 at risk
EG0022 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0014 affected24 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected9 at risk
EG0013 affected24 at risk
EG0020 affected3 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hypouricaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0017 affected24 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0013 affected24 at risk
EG0020 affected3 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Sacral pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Soft tissue mass
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Aura
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Brain fog
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0021 affected3 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0017 affected24 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Migraine
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0013 affected24 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0021 affected3 at risk
EG003
Emotional distress
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0015 affected24 at risk
EG0020 affected3 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0021 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Urge incontinence
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Urine flow decreased
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Breast disorder
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Penile discomfort
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0003 affected9 at risk
EG0012 affected24 at risk
EG0021 affected3 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0004 affected9 at risk
EG0015 affected24 at risk
EG0022 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Dandruff
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0021 affected3 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Sensitive skin
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Aneurysm
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Embolism
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected24 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0012 affected24 at risk
EG0020 affected3 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected24 at risk
EG0020 affected3 at risk
EG003
The study was terminated early. And phase 2 portion of the study was not conducted.
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, 2 weeks on/1 week off
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 2 weeks on and 1 week off (21 day cycle)
OG004
Arm 1: 70mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly
70 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg niraparib taken QD orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
OG005
Arm 2: 50mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 150 mg olaparib taken BID (twice a day) orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
OG006
Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 3d on/4d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
OG007
Arm 2: 50mg QD camonsertib + 200 mg QD olaparib, 3d on/4 d off, weekly
50 mg RP-3500 (camonsertib) taken QD orally in combination with 200 mg olaparib taken QD orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
OG008
Arm 2: 80mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly
80 mg RP-3500 (camonsertib) taken QD orally in combination with 150 mg olaparib taken BID orally, same day on a 3 days on and 4 days off schedule for 3 weeks (21 day cycle)
50 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 2 days on and 5 days off schedule for 3 weeks (21 day cycle)
OG010
Arm 2: 80mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, 2w on/1w off
80 mg RP-3500 (camonsertib) taken QD orally in combination with 100 mg olaparib taken BID orally, same day on a 2 days on and 5 days off schedule for 2 weeks on and 1 week off (21 day cycle)