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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20160828 | Registry Identifier | ChiCTR |
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This study is designed to evaluate the safety, tolerability, PKharmacokinetic profile and treatment effect of pamiparib in Chinese participants with advanced high-grade ovarian cancer (including fallopian cancer or primary peritoneal cancer) and triple negative breast cancer in phase I, and to evaluate the efficacy and safety of pamiparib in Chinese participants with recurrent epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline breast cancer susceptibility gene 1/gene 2 (BRCA1/2) mutation in phase II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: 20 milligram (mg) pamiparib | Experimental | 20 mg pamiparib twice a day for 21 days |
|
| Phase 1 : 40 mg pamiparib | Experimental | 40 mg pamiparib twice a day for 21 days |
|
| 60 mg pamiparib | Experimental | 60 mg pamiparib twice a day for 21 days |
|
| 60 mg pamiparib in platinum-sensitive ovarian cancer (PSOC) | Experimental | 60 mg pamiparib twice a day until occurrence of unacceptable toxicities, disease progression, withdrawal of consent or investigator discretion |
|
| 60 mg pamiparib in platinum resistant ovarian cancer (PROC) | Experimental | 60 mg pamiparib twice a day until occurrence of unacceptable toxicities, disease progression, withdrawal of consent or investigator discretion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamiparib | Drug | Pamiparib is provided as oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: 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 or was worsening in severity from baseline (pretreatment). | From first dose to within 30 days of last dose of pamiparib (approximately 36 months) |
| Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs) | From first dose to within 30 days of last dose of pamiparib (approximately 36 months) | |
| Phase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC) | ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response | Up to approximately 2 years and 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Maximum Observed Plasma Concentration (Cmax) | Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose | |
| Phase I: Time to Reach Cmax (Tmax) | Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
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Key Inclusion Criteria:
2) In Phase 2 portion: Participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation 4. Participants must have measurable disease as defined per the RECIST, version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
| Beijing Cancer Hospital |
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This study consisted of 2 Phases. Phase 1 (December 2016 to December 2019) in which 15 participants were enrolled and Phase 2 (December 2017 to August 2021) in which 113 participants were enrolled. Primary data cut off date for Phase 1 was 24 December 2019 and Primary cut-off date for Phase 2 was 24 August 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: 20 Milligram (mg) Pamiparib | Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| FG001 | Phase 1: 40 mg Pamiparib | Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| FG002 | Phase 1: 60 mg Pamiparib | Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| FG003 | Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC) | Participants with PSOC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| FG004 | Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC) | Participants with PROC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set includes all participants who received at least one dose of pamiparib
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: 20 mg Pamiparib | Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Phase 1: 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 or was worsening in severity from baseline (pretreatment). | Safety Analysis Set includes all participants who received at least one dose of pamiparib | Posted | Number | Number of participants | From first dose to within 30 days of last dose of pamiparib (approximately 36 months) |
|
Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: 20 mg Pamiparib | Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment | Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2018 | Jul 21, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2020 | Jul 21, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C000707927 | pamiparib |
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|
| Phase I: Terminal Elimination Half-life (t1/2) | Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
| Phase I: Apparent Clearance (CL/F) | Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
| Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) | Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
| Phase I: Apparent Volume of Distribution During Terminal Phase (Vz/F) | Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
| Phase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1 | ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR) | Up to approximately 36 months |
| Phase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1 | DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD) | Up to approximately 36 months |
| Phase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1 | CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks | Up to approximately 36 months |
| Phase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1 | DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first | Up to approximately 36 months |
| Phase I : Progression Free Survival (PFS) | PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first | Up to approximately 36 months |
| Phase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1 | ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response | Up to approximately 3 years and 8 months |
| Phase 2: Disease Control Rate by Investigator Per RECIST v1.1 | DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD) | Up to approximately 3 years and 8 months |
| Phase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1 | CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks | Up to approximately 3 years and 8 months |
| Phase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria | CA-125 response is defined the percentage of participants with at least 50% reduction in CA-125 levels from pre-treatment sample | Up to approximately 3 years and 8 months |
| Phase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1 | DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first | Up to approximately 3 years and 8 months |
| Phase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1 | PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first | Up to approximately 3 years and 8 months |
| Phase 2: Overall Survival (OS) as Assessed by Investigator | OS is defined as time from the first dose of study medication to the date of death due to any cause | Up to approximately 3 years and 8 months |
| Phase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events | 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 or was worsening in severity from baseline (pretreatment). All clinically significant abnormalities in physical examinations, laboratory tests and ECGs are reported as adverse events (AE) in the AE section. | From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months) |
| Phase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12) | Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
| Phase 2: Maximum Observed Plasma Concentration (Cmax) | Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
| Phase 2: Time to Reach Cmax (Tmax) | Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
| Phase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9) | Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
| Beijing |
| Beijing Municipality |
| 100142 |
| China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Disease Progression |
|
| Death |
|
| Sponsor's Decision |
|
| Withdrawal by Subject |
|
| BG001 | Phase 1: 40 mg Pamiparib | Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| BG002 | Phase 1: 60 mg Pamiparib | Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| BG003 | Phase 2: 60 mg Pamiparib in PSOC | Participants with PSOC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| BG004 | Phase 2: 60 mg Pamiparib in PROC | Participants with PROC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Phase 1: 40 mg Pamiparib | Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
| OG002 | Phase 1: 60 mg Pamiparib | Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days |
|
|
| Primary | Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs) | Safety Analysis Set | Posted | Number | Number of participants | From first dose to within 30 days of last dose of pamiparib (approximately 36 months) |
|
|
|
| Primary | Phase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC) | ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response | Efficacy Evaluable Set defined as all participants in the Safety Analysis Set who had measurable disease at baseline per RECIST v1.1. participants with available data were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 2 years and 8 months |
|
|
|
| Secondary | Phase I: Maximum Observed Plasma Concentration (Cmax) | PK Analysis Set was defined as all participants for whom valid PK parameters could be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
|
|
|
| Secondary | Phase I: Time to Reach Cmax (Tmax) | PK Analysis Set | Posted | Median | Full Range | hours | Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
|
|
|
| Secondary | Phase I: Terminal Elimination Half-life (t1/2) | PK Analysis Set | Posted | Geometric Mean | Full Range | hours | Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
|
|
|
| Secondary | Phase I: Apparent Clearance (CL/F) | PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour (L/h) | Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
|
|
|
| Secondary | Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) | Pharmacokinetic (PK) Analysis Set includes all participants for whom valid pamiparib PK parameters could be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms/milliliter (h*ng/mL) | Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
|
|
|
| Secondary | Phase I: Apparent Volume of Distribution During Terminal Phase (Vz/F) | PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
|
|
|
| Secondary | Phase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1 | ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR) | Efficacy Evaluable Set includes all participants in the safety analysis set who had the measurable disease at baseline per RECIST v1.1 and had at least one post-baseline tumor assessment unless discontinued due to clinical progression or death prior to assessment | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 36 months |
|
|
|
| Secondary | Phase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1 | DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD) | Efficacy Evaluable Set includes all participants in the safety analysis set who had the measurable disease at baseline per RECIST v1.1 and had at least one post-baseline tumor assessment unless discontinued due to clinical progression or death prior to assessment | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 36 months |
|
|
|
| Secondary | Phase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1 | CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks | Efficacy Evaluable Set | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 36 months |
|
|
|
| Secondary | Phase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1 | DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first | Efficacy Evaluable Set; Only the number of responders were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Up to approximately 36 months |
|
|
|
| Secondary | Phase I : Progression Free Survival (PFS) | PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first | Safety Analysis Set | Posted | Median | 95% Confidence Interval | Months | Up to approximately 36 months |
|
|
|
| Secondary | Phase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1 | ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response | Efficacy Analysis Set; Participants with available data were included in the analysis | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years and 8 months |
|
|
|
| Secondary | Phase 2: Disease Control Rate by Investigator Per RECIST v1.1 | DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD) | Efficacy Analysis Set; Participants with available data were included in the analysis | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years and 8 months |
|
|
|
| Secondary | Phase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1 | CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks | Efficacy Analysis Set; Participants with available data were included in the analysis | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years and 8 months |
|
|
|
| Secondary | Phase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria | CA-125 response is defined the percentage of participants with at least 50% reduction in CA-125 levels from pre-treatment sample | CA-125 Evaluable Analysis Set is defined as a subset of participants in the Safety Analysis with baseline CA-125 >/= 2 X upper limit of normal (ULN) | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years and 8 months |
|
|
|
| Secondary | Phase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1 | DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first | Efficacy Evaluable Set : Participants with available data were included in the analysis | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 8 months |
|
|
|
| Secondary | Phase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1 | PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first | Safety Analysis Set | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 8 months |
|
|
|
| Secondary | Phase 2: Overall Survival (OS) as Assessed by Investigator | OS is defined as time from the first dose of study medication to the date of death due to any cause | Safety Analysis Set | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 8 months |
|
|
|
| Secondary | Phase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events | 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 or was worsening in severity from baseline (pretreatment). All clinically significant abnormalities in physical examinations, laboratory tests and ECGs are reported as adverse events (AE) in the AE section. | Safety Analysis Set | Posted | Number | Number of participants | From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months) |
|
|
|
| Secondary | Phase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12) | PK Analysis Set: Participants with at least one available PK parameter at the specified visit were included in the analysis. Phase 2 PK analyses were performed for all Phase 2 participants combined per protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanograms/milliliter (h*ng/mL) | Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
|
|
|
| Secondary | Phase 2: Maximum Observed Plasma Concentration (Cmax) | PK Analysis Set: Participants with at least one available PK parameter at the specified visit were included in the analysis. Phase 2 PK analyses were performed for all Phase 2 participants combined per protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
|
|
|
| Secondary | Phase 2: Time to Reach Cmax (Tmax) | PK Analysis Set: Participants with at least one available PK parameter at the specified visit were included in the analysis. Phase 2 PK analyses were performed for all Phase 2 participants combined per protocol. | Posted | Median | Full Range | hours | Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
|
|
|
| Secondary | Phase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9) | PK Analysis Set: Participants with at least one available PK parameter at the specified visit were included in the analysis. Phase 2 PK analyses were performed for all Phase 2 participants combined per protocol.. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Phase 1: 40 mg Pamiparib | Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days | 0 | 4 | 1 | 4 | 4 | 4 |
| EG002 | Phase 1: 60 mg Pamiparib | Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days | 0 | 7 | 2 | 7 | 7 | 7 |
| EG003 | Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC) | Participants with PSOC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days | 37 | 90 | 36 | 90 | 90 | 90 |
| EG004 | Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC) | Participants with PROC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days | 18 | 23 | 15 | 23 | 22 | 23 |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Enterovesical fistula | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Erythropenia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Gastric dilatation | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Bilirubin urine present | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood bilirubin unconjugated increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Monocyte count decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Neutrophil percentage increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Procalcitonin increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Total bile acids increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Urine ketone body present | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Urobilinogen urine increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (22.0/24.0) | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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