Efficacy and Safety of BGB-290 in the Treatment of Metast... | NCT03575065

NCT03575065

ID	Type	Description	Link
CTR20171623	Registry Identifier	National Medical Products Administration- NMPA

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: Triple-negative breast cancer (TNBC)	Experimental	Locally advanced or metastatic TNBC	Drug: BGB-290
Cohort 2: HR(+)/HER2(-) breast cancer	Experimental	Locally advanced or metastatic Hormone receptor-positive(HR+) human epidermal growth factor receptor2 Negative(HER2-) breast cancer	Drug: BGB-290

Name	Type	Description	Arm Group Labels	Other Names
BGB-290	Drug	Administered orally	Cohort 1: Triple-negative breast cancer (TNBC) Cohort 2: HR(+)/HER2(-) breast cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC)	ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by IRC per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)	From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 months)

Secondary Outcomes

Measure	Description	Time Frame
ORR as Assessed by Investigator	ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)	From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation
Locally advanced or metastatic breast cancer despite standard therapy and the following:
1. Histologically or cytologically confirmed HER2(-) breast cancer (TNBC or estrogen receptor-positive and/or PR+)
2. ≤ 2 prior lines of chemotherapy in advanced or metastatic setting
3. Prior platinum therapy allowed as long as no disease progression while on treatment, or if given in neoadjuvant/adjuvant setting with ≥ 6 months from last platinum to relapse
4. Prior therapy with an anthracycline and/or a taxane in neoadjuvant/adjuvant or metastatic setting
5. Archival tumor tissues will be collected from all patients, if available
6. For HR(+)/HER2(-) breast cancer only: patients must have received and progressed on at least one endocrine therapy either in adjuvant or metastatic setting, or have disease that the treating physician believes to be inappropriate for endocrine therapy
Measurable disease as defined per RECIST, version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Adequate hematologic and organ function

Exclusion Criteria:

Unresolved acute effects of prior therapy of ≥ Grade 2
Prior treatment with a poly[ADP-ribose] polymerase (PARP) inhibitor
Chemotherapy, radiotherapy, biologic therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤ 5 half lives, if applicable, whichever is shorter) prior to Day 1 of Cycle 1
Major surgical procedure, open biopsy, or significant traumatic injury ≤ 14 days prior to Day 1 of Cycle 1, or anticipation of need for major surgical procedure during the course of the study
Diagnosis of myelodysplastic syndrome (MDS)
Other diagnosis of malignancy
Untreated and/or active brain metastases.
Active infection requiring systemic treatment, active viral hepatitis, or active tuberculosis
Clinically significant cardiovascular disease
Pregnancy or nursing
Known history of intolerance to the excipients of the BGB-290 capsule

Contacts/Locations Module

Name	Affiliation	Role
Study Director	BeiGene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital Chinese Academy of Medical Sciences		Beijing	Beijing Municipality	100021	China
Fujian Medical University Union Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Xu B, Zhang QY, Yang H, Gu T, Zhang K, Liang J, Qiu JJ, Yang R, Zhang L, Mu S, Sun J, Huang V, Dong M. An Open-Label, Multicenter, Phase 2 Study to Evaluate the Antitumor Activity and Safety of Pamiparib in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China. Chinese Society of Clinical Oncology. 2018.
36459284	Background	Xu B, Sun T, Shi Y, Cui J, Yin Y, Ouyang Q, Liu Q, Zhang Q, Chen Y, Wang S, Wang X, Tong Z, Zhong Y, Wang J, Yan M, Yan X, Wang C, Feng J, Wang X, Hu G, Cheng Y, Ge R, Zhu Z, Zhang W, Shao Z. Pamiparib in patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutations: a phase II study. Breast Cancer Res Treat. 2023 Feb;197(3):489-501. doi: 10.1007/s10549-022-06785-z. Epub 2022 Dec 2.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Triple-negative Breast Cancer (TNBC)	Participants received 60 milligrams (mg) pamiparib twice daily (BID) orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
FG001	Hormone Receptor-positive(HR+) Human Epidermal Growth Factor receptor2 Negative(HER2-) Breast Cancer

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 30, 2018	Mar 28, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Safety Analysis Set included all participants who received at least 1 dose of pamiparib (BGB-290)

Arm/Group Information

ID	Title	Description
BG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
BG001	HR(+)/HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00045.6± 8.56 BG00146.4± 10.75 BG00245.8± 9.20

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00062 BG00126 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Asian - Chinese

Title	Measurements
	BG00062 BG00126 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

Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC)

ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by IRC per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Efficacy Evaluable Analysis Set: includes all participants in the safety population who have measurable disease at baseline per RECIST v1.1 by IRC and have at least one evaluable post baseline tumor assessment by IRC unless discontinued treatment due to clinical progression or death prior to tumor assessment. Participants with available data were included in the analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 months)

ID	Title	Description
OG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
OG001	HR(+) /HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor

Units	Counts
Participants	OG00055 OG00121

Title

Denominators

Categories

Title	Measurements
	OG00038.2(25.4 to 52.3) OG00161.9(38.4 to 81.9)

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		Exact Binomial Test		0.0210	p-value was based on an exact binomial test with historic control ORR=0.25													Superiority

Secondary

ORR as Assessed by Investigator

ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Efficacy Evaluable Analysis Set; Participants with available data were included in the analysis

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months)

ID	Title	Description
OG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
OG001	HR(+) /HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor

Units	Counts
Participants

Secondary

Progression-free Survival (PFS) as Assessed by IRC and Investigator

PFS is defined as the time from first dose of pamiparib to the first documented disease progression or death due to any cause, assessed by IRC or the investigator

Safety Analysis Set

Posted

Median

95% Confidence Interval

Months

From the first dose of pamiparib to first documentation of disease progression or death (Approximately 2 years and 10 months)

ID	Title	Description
OG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
OG001	HR(+) /HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor

Units	Counts
Participants	OG000

Secondary

Duration of Response (DOR) as Assessed by IRC

DOR is defined as the time from first determination of a confirmed best overall response until the first documentation of progression or death, whichever comes first, assessed by IRC

Efficacy Evaluable Analysis Set; Only the participants with confirmed objective responses by IRC were included in DOR analysis;

Posted

Median

95% Confidence Interval

Months

From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months)

ID	Title	Description
OG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
OG001	HR(+) /HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor

Units	Counts
Participants

Secondary

Duration of Response (DOR) as Assessed by the Investigator

DOR is defined as the time from first determination of a confirmed best overall response until the first documentation of progression or death, whichever comes first, assessed by the investigator

Efficacy Evaluable Analysis Set; Only the participants with confirmed objective responses by Investigator were included in DOR analysis.

Posted

Median

95% Confidence Interval

Months

From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months)

ID	Title	Description
OG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
OG001	HR(+) /HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor

Units	Counts
Participants

Secondary

Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator

BOR is defined as the percentage of participants with best overall response recorded from the start of the treatment until disease progression or recurrence, assessed by IRC or the investigator. BOR included complete response [CR], partial response [PR], stable disease [SD], disease progression and not evaluable [NE].

Efficacy Evaluable Analysis Set; Participants with available data were included in the analysis

Posted

Number

Percentage of participants

Approximately 2 years and 10 months

ID	Title	Description
OG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
OG001	HR(+) /HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor

Units	Counts
Participants

Secondary

Disease Control Rate (DCR) as Assessed by IRC and Investigator

DCR is defined as the percentage of participants who achieved a confirmed BOR of CR, PR, or stable disease (SD), assessed by IRC or the investigator

Efficacy Evaluable Set; Participants with available data were included in the analysis

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months).

ID	Title	Description
OG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
OG001	HR(+) /HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor

Units	Counts
Participants

Secondary

Clinical Benefit Rate (CBR) as Assessed by IRC and Investigator

CBR is defined as percentage of participants with confirmed CR or confirmed PR or a durable SD (SD lasting ≥ 24 weeks), assessed by IRC or the investigator

Efficacy Evaluable Set; Participants with available data were analyzed.

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months)

ID	Title	Description
OG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
OG001	HR(+) /HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor

Units	Counts
Participants

Secondary

Overall Survival (OS)

OS is defined as time from the first dose of pamiparib to the date of death due to any cause

Safety Analysis Set

Posted

Median

95% Confidence Interval

Months

From the first dose of pamiparib until death (approximately 2 years and 10 months)

ID	Title	Description
OG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
OG001	HR(+) /HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor

Units	Counts
Participants	OG000

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation. SAE is defined as any AE that leads to death or is life-threatening.

Safety Analysis Set

Posted

Number

participants

Up to approximately 2 years and 10 months

ID	Title	Description
OG000	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
OG001	HR(+) / HER2(-) Breast Cancer	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor

Units	Counts
Participants	OG000

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	TNBC	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	31	62	12	62	61	62
EG001	HR(+)/HER2(-)	Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	12	26	7	26	26	26

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG0007 events7 affected62 at risk EG0013 events3 affected26 at risk
Febrile neutropenia	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Leukopenia	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk
Neutropenia	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected26 at risk
Thrombocytopenia	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected26 at risk
Cataract	Eye disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Diarrhoea	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected26 at risk
Death	General disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected26 at risk
Upper respiratory tract infection	Infections and infestations	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Alanine aminotransferase increased	Investigations	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Aspartate aminotransferase increased	Investigations	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Platelet count decreased	Investigations	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected26 at risk
Spinal meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Altered state of consciousness	Nervous system disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected26 at risk
Cerebral haemorrhage	Nervous system disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected26 at risk
Acute kidney injury	Renal and urinary disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected26 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected26 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected26 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG00079 events51 affected62 at risk EG00140 events26 affected26 at risk
Leukopenia	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG00020 events8 affected62 at risk EG00115 events6 affected26 at risk
Lymph node pain	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events1 affected26 at risk
Lymphopenia	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG0007 events3 affected62 at risk EG0017 events3 affected26 at risk
Neutropenia	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG00015 events5 affected62 at risk EG00110 events5 affected26 at risk
Thrombocytopenia	Blood and lymphatic system disorders	meddra 23.0	Systematic Assessment	EG0008 events4 affected62 at risk EG0013 events3 affected26 at risk
Palpitations	Cardiac disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Sinus tachycardia	Cardiac disorders	meddra 23.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0010 events0 affected26 at risk
Tachycardia	Cardiac disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Tinnitus	Ear and labyrinth disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk
Vertigo	Ear and labyrinth disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk
Eyelid oedema	Eye disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Abdominal discomfort	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0004 events2 affected62 at risk EG0013 events3 affected26 at risk
Abdominal distension	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0007 events6 affected62 at risk EG0011 events1 affected26 at risk
Abdominal pain	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events2 affected26 at risk
Abdominal pain upper	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0008 events5 affected62 at risk EG0011 events1 affected26 at risk
Constipation	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0004 events4 affected62 at risk EG0011 events1 affected26 at risk
Diarrhoea	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG00011 events10 affected62 at risk EG0017 events7 affected26 at risk
Dyspepsia	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0004 events2 affected62 at risk EG0010 events0 affected26 at risk
Flatulence	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected26 at risk
Gingival pain	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events1 affected26 at risk
Gingival swelling	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events1 affected26 at risk
Mouth ulceration	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0010 events0 affected26 at risk
Nausea	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG00041 events29 affected62 at risk EG00135 events15 affected26 at risk
Toothache	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected26 at risk
Vomiting	Gastrointestinal disorders	meddra 23.0	Systematic Assessment	EG00032 events22 affected62 at risk EG00130 events14 affected26 at risk
Asthenia	General disorders	meddra 23.0	Systematic Assessment	EG00010 events9 affected62 at risk EG0014 events4 affected26 at risk
Chest discomfort	General disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected26 at risk
Fatigue	General disorders	meddra 23.0	Systematic Assessment	EG0005 events5 affected62 at risk EG0015 events2 affected26 at risk
Influenza like illness	General disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0012 events2 affected26 at risk
Malaise	General disorders	meddra 23.0	Systematic Assessment	EG00011 events11 affected62 at risk EG0014 events4 affected26 at risk
Non-cardiac chest pain	General disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk
Oedema peripheral	General disorders	meddra 23.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0010 events0 affected26 at risk
Peripheral swelling	General disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Pyrexia	General disorders	meddra 23.0	Systematic Assessment	EG0004 events4 affected62 at risk EG0011 events1 affected26 at risk
Swelling face	General disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Cholelithiasis	Hepatobiliary disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Hepatic steatosis	Hepatobiliary disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected26 at risk
Contrast media allergy	Immune system disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events2 affected26 at risk
Gastroenteritis	Infections and infestations	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Herpes zoster	Infections and infestations	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected26 at risk
Influenza	Infections and infestations	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk
Nasopharyngitis	Infections and infestations	meddra 23.0	Systematic Assessment	EG0006 events5 affected62 at risk EG0010 events0 affected26 at risk
Pneumonia	Infections and infestations	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected26 at risk
Upper respiratory tract infection	Infections and infestations	meddra 23.0	Systematic Assessment	EG0009 events6 affected62 at risk EG00110 events6 affected26 at risk
Urinary tract infection	Infections and infestations	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0013 events3 affected26 at risk
Foot fracture	Injury, poisoning and procedural complications	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Ligament injury	Injury, poisoning and procedural complications	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Meniscus injury	Injury, poisoning and procedural complications	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Thermal burn	Injury, poisoning and procedural complications	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Alanine aminotransferase increased	Investigations	meddra 23.0	Systematic Assessment	EG00017 events13 affected62 at risk EG00110 events10 affected26 at risk
Aspartate aminotransferase increased	Investigations	meddra 23.0	Systematic Assessment	EG00013 events10 affected62 at risk EG0017 events7 affected26 at risk
Bilirubin conjugated increased	Investigations	meddra 23.0	Systematic Assessment	EG0004 events3 affected62 at risk EG0015 events3 affected26 at risk
Blood alkaline phosphatase increased	Investigations	meddra 23.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0018 events6 affected26 at risk
Blood bilirubin increased	Investigations	meddra 23.0	Systematic Assessment	EG00010 events8 affected62 at risk EG0018 events7 affected26 at risk
Blood bilirubin unconjugated increased	Investigations	meddra 23.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0015 events4 affected26 at risk
Blood creatinine increased	Investigations	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0013 events3 affected26 at risk
Blood lactate dehydrogenase increased	Investigations	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected26 at risk
Blood triglycerides increased	Investigations	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected26 at risk
Electrocardiogram QT prolonged	Investigations	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected26 at risk
Gamma-glutamyltransferase increased	Investigations	meddra 23.0	Systematic Assessment	EG0005 events4 affected62 at risk EG0012 events2 affected26 at risk
Lipoprotein (a) increased	Investigations	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected26 at risk
Low density lipoprotein increased	Investigations	meddra 23.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0011 events1 affected26 at risk
Lymphocyte count decreased	Investigations	meddra 23.0	Systematic Assessment	EG0008 events6 affected62 at risk EG0012 events1 affected26 at risk
Neutrophil count decreased	Investigations	meddra 23.0	Systematic Assessment	EG000111 events34 affected62 at risk EG00128 events18 affected26 at risk
Platelet count decreased	Investigations	meddra 23.0	Systematic Assessment	EG00028 events19 affected62 at risk EG00111 events11 affected26 at risk
Weight decreased	Investigations	meddra 23.0	Systematic Assessment	EG00014 events11 affected62 at risk EG0011 events1 affected26 at risk
Weight increased	Investigations	meddra 23.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0012 events2 affected26 at risk
White blood cell count decreased	Investigations	meddra 23.0	Systematic Assessment	EG000132 events35 affected62 at risk EG00135 events21 affected26 at risk
Decreased appetite	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG00028 events25 affected62 at risk EG0019 events8 affected26 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG0005 events1 affected62 at risk EG0011 events1 affected26 at risk
Hyperglycaemia	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG0005 events5 affected62 at risk EG0012 events2 affected26 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected26 at risk
Hyperuricaemia	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0012 events2 affected26 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk
Hypocalcaemia	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events2 affected26 at risk
Hypochloraemia	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events2 affected26 at risk
Hypokalaemia	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk
Hyponatraemia	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0012 events2 affected26 at risk
Hypophosphataemia	Metabolism and nutrition disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0013 events2 affected26 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	meddra 23.0	Systematic Assessment	EG0006 events5 affected62 at risk EG0011 events1 affected26 at risk
Back pain	Musculoskeletal and connective tissue disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0016 events6 affected26 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0015 events2 affected26 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	meddra 23.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0012 events2 affected26 at risk
Myalgia	Musculoskeletal and connective tissue disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Neck pain	Musculoskeletal and connective tissue disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected26 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events2 affected26 at risk
Synovitis	Musculoskeletal and connective tissue disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Dizziness	Nervous system disorders	meddra 23.0	Systematic Assessment	EG0007 events6 affected62 at risk EG0016 events3 affected26 at risk
Dysgeusia	Nervous system disorders	meddra 23.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0010 events0 affected26 at risk
Headache	Nervous system disorders	meddra 23.0	Systematic Assessment	EG0006 events6 affected62 at risk EG0012 events2 affected26 at risk
Hypoaesthesia	Nervous system disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk
Somnolence	Nervous system disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected26 at risk
Insomnia	Psychiatric disorders	meddra 23.0	Systematic Assessment	EG0007 events6 affected62 at risk EG0017 events5 affected26 at risk
Breast pain	Reproductive system and breast disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events1 affected26 at risk
Breast swelling	Reproductive system and breast disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk
Cough	Respiratory, thoracic and mediastinal disorders	meddra 23.0	Systematic Assessment	EG0006 events6 affected62 at risk EG0014 events4 affected26 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected26 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	meddra 23.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0012 events1 affected26 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	meddra 23.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0013 events2 affected26 at risk
Alopecia	Skin and subcutaneous tissue disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected26 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected26 at risk
Pain of skin	Skin and subcutaneous tissue disorders	meddra 23.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events1 affected26 at risk
Pruritus	Skin and subcutaneous tissue disorders	meddra 23.0	Systematic Assessment	EG0004 events4 affected62 at risk EG0010 events0 affected26 at risk
Rash	Skin and subcutaneous tissue disorders	meddra 23.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected26 at risk

ID	Term
C000707927	pamiparib