Study of CB-839 in Combination w/ Paclitaxel in Participa... | NCT03057600

Label	Type	Description	Intervention Names
Cohort 1 - African ancestry, 3rd line+	Experimental	Intervention = Paclitaxel- CB-839 (Pac-CB) combination Participants must self-identify as African ancestry (includes African American). At least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane. Prior taxane (paclitaxel, docetaxel, or nab-paclitaxel) for advanced/metastatic disease is required but must not have been received in the immediate prior line of therapy. Systemic neoadjuvant and/or adjuvant therapy is considered a line of therapy for advanced/metastatic disease if the time to recurrence from completion of treatment was ≤ 12 mo.	Drug: Paclitaxel Drug: CB-839
Cohort 2 - African ancestry, 1st line	Experimental	Intervention = Pac-CB combination Participants must self-identify as African ancestry (includes African American). No prior systemic therapy for advanced or metastatic disease. Systemic neoadjuvant or adjuvant therapy, including taxane, is allowed if time to recurrence was > 12 mo.	Drug: Paclitaxel Drug: CB-839
Cohort 3 - Non-African ancestry, 3rd line+	Experimental	Intervention = Pac-CB combination Participants do not self-identify as African ancestry. Otherwise have the same criteria as Cohort 1.	Drug: Paclitaxel Drug: CB-839
Cohort 4 - Non-African ancestry, 1st line	Experimental	Intervention = Pac-CB combination Participants do not self-identify as African ancestry. Otherwise have the same criteria as Cohort 2.

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel	Drug	standard weekly paclitaxel in 28-day cycles	Cohort 1 - African ancestry, 3rd line+ Cohort 2 - African ancestry, 1st line Cohort 3 - Non-African ancestry, 3rd line+

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessment performed no less than 4 weeks after the criteria for response were first met.	Maximum duration of follow-up for ORR was 14.8 months.

Measure	Description	Time Frame
Progression Free Survival (PFS) as Assessed by Investigator	PFS was defined as time from the first dose date to the earlier of either progression of disease per RECIST v1.1 or death from any cause. The duration of progression-free survival was censored at the date of last radiographic disease if the patient was alive and progression free at the time of analysis data cutoff, disease progression or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol TNBC treatment prior to documentation of disease progression. Kaplan-Meier product-limit estimates. Brookmeyer-Crowley methodology for a non-parametric 95% confidence interval (CI) is used. Progressive Disease (PD) per RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.

Name	Affiliation	Role
Sam Whiting, MD, PhD	Calithera Biosciences, Inc	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Brimingham		Birmingham	Alabama	35294	United States
University of South Alabama, Mitchell Cancer Institute

ID	Title	Description
FG000	Cohort 1 - African Ancestry, 3rd Line+	Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 6, 2017	Aug 18, 2022

Type

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Description

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Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

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Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Response Rate (ORR)

ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1criteria:

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessment performed no less than 4 weeks after the criteria for response were first met.

Response Evaluable Analysis Set: all participants who had measurable disease at baseline, received at least 1 dose of study drug (telaglenastat or paclitaxel) and completed at least 1 post baseline tumor assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Maximum duration of follow-up for ORR was 14.8 months.

ID	Title	Description
OG000	Cohort 1 - African Ancestry, 3rd Line+	Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
OG001	Cohort 2 - African Ancestry, 1st Line	Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
OG002	Cohort 3 - Non-African Ancestry, 3rd Line+	Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
OG003	Cohort 4 - Non-African Ancestry, 1st Line	Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.

Units	Counts
Participants	OG0009 OG00110 OG00219 OG003

Title

Denominators

Categories

Title	Measurements
	OG00022.2(2.8 to 60.0) OG00110.0(0.3 to 44.5) OG00210.5(1.3 to 33.1) OG003

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 one-sample binomial tests		0.2252														Superiority
OG001		exact one-sample binomial tests		0.9437

Secondary

Progression Free Survival (PFS) as Assessed by Investigator

PFS was defined as time from the first dose date to the earlier of either progression of disease per RECIST v1.1 or death from any cause. The duration of progression-free survival was censored at the date of last radiographic disease if the patient was alive and progression free at the time of analysis data cutoff, disease progression or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol TNBC treatment prior to documentation of disease progression. Kaplan-Meier product-limit estimates. Brookmeyer-Crowley methodology for a non-parametric 95% confidence interval (CI) is used.

Progressive Disease (PD) per RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.

PFS Evaluable Analysis Set: all participants who received at least 1 dose of any study-specific treatment (telaglenastat or paclitaxel).

Posted

Median

95% Confidence Interval

months

Maximum duration of follow-up for PFS was 17.0 months.

ID	Title	Description
OG000	Cohort 1 - African Ancestry, 3rd Line+	Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.

Secondary

Overall Survival (OS)

Overall survival is defined as the time from the first dose date to death due to any cause. For patients alive at time of analysis, overall survival will be censored at the time when the patient is last known to be alive.Kaplan-Meier product-limit estimates. Brookmeyer-Crowley methodology for a non-parametric 95% CI is used. Median is defined to be the smallest observed survival time for which the value of the estimated survival function is less than or equal to 0.5.

PFS Evaluable Analysis Set: all participants who received at least 1 dose of any study-specific treatment (telaglenastat or paclitaxel).

Posted

Median

95% Confidence Interval

months

Maximum duration of follow-up for OS was 24.1 months.

ID	Title	Description
OG000	Cohort 1 - African Ancestry, 3rd Line+	Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
OG001	Cohort 2 - African Ancestry, 1st Line	Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.

Secondary

Duration of Response (DOR)

Duration of response is defined as the time between the first documentation of a confirmed PR or a CR to the first documentation of PD or death, whichever occurs first. The duration of response will be censored at the date of last radiographic disease if the patient is alive and progression free at the time of database lock, disease progression or death occurs after missing data for two consecutive radiographic disease assessments, or patient receives non-protocol TNBC treatment prior to documentation of disease progression.

RECIST v1.1 criteria:

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.

Posted

Median

95% Confidence Interval

months

Maximum duration of follow-up for DOR was 14.8 months.

ID	Title	Description
OG000	Cohort 1 - African Ancestry, 3rd Line+	Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.

Secondary

Clinical Benefit Rate (CBR)

Clinical Benefit Rate is defined as the percentage of patients with best response of CR, PR, or SD per RECIST v1.1 criteria lasting ≥ 16 weeks for 3rd line + patients and ≥ 24 weeks for 1st line patients. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Posted

Number

95% Confidence Interval

percentage of participants

Maximum duration of follow-up for CBR was 14.8 months.

ID	Title	Description
OG000	Cohort 1 - African Ancestry, 3rd Line+	Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
OG001	Cohort 2 - African Ancestry, 1st Line

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	Cohort 1 - African Ancestry, 3rd Line+	Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.	7	9	2	9	9	9
EG001	Cohort 2 - African Ancestry, 1st Line	Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.	7	10	2	10	10	10
EG002	Cohort 3 - Non-African Ancestry, 3rd Line+	Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.	14	20	5	20	19	20
EG003	Cohort 4 - Non-African Ancestry, 1st Line	Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.	7	13	2	13	13	13

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG0030 affected13 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Appendicitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Cellulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Septic shock	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Influenza like illness	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Seizure	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypotension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected9 at risk EG0013 affected10 at risk EG00210 affected20 at risk EG00310 affected13 at risk
Oedema peripheral	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected10 at risk EG0023 affected20 at risk EG003
Chest pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0023 affected20 at risk EG003
Pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Chills	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Influenza like illness	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Mucosal inflammation	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Oedema	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Peripheral swelling	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Asthenia	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Axillary pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Chest discomfort	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Generalised oedema	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Localised oedema	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Swelling	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected9 at risk EG0011 affected10 at risk EG0028 affected20 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0015 affected10 at risk EG0025 affected20 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected9 at risk EG0012 affected10 at risk EG0023 affected20 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0025 affected20 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Oral herpes	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected9 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected9 at risk EG0011 affected10 at risk EG0026 affected20 at risk EG003
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected10 at risk EG0022 affected20 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected10 at risk EG0020 affected20 at risk EG003
Ataxia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Aphasia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Jugular vein occlusion	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Syncope	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected9 at risk EG0014 affected10 at risk EG0027 affected20 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0026 affected20 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0014 affected10 at risk EG0025 affected20 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0014 affected10 at risk EG0024 affected20 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected10 at risk EG0023 affected20 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected10 at risk EG0021 affected20 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypouricaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
White blood cell count decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected9 at risk EG0013 affected10 at risk EG0023 affected20 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
Weight decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Platelet count decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Blood creatinine increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Weight increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected10 at risk EG0024 affected20 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected10 at risk EG0021 affected20 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0023 affected20 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Lung infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected10 at risk EG0022 affected20 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0023 affected20 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected9 at risk EG0013 affected10 at risk EG0024 affected20 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Nail bed disorder	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Rash pustular	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Scratch	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0014 affected10 at risk EG0025 affected20 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Bronchitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fungal infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Mucosal infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Otitis media	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Skin infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Photophobia	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected10 at risk EG0024 affected20 at risk EG003
Vision blurred	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected10 at risk EG0020 affected20 at risk EG003
Dry eye	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cataract	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Eye disorder	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Ocular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0013 affected10 at risk EG0021 affected20 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Depression	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Irritability	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypertension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected10 at risk EG0021 affected20 at risk EG003
Hot flush	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypotension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Palpitations	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Recall phenomenon	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Mastitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Cohort 1 - African Ancestry, 3rd Line+	Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
BG001	Cohort 2 - African Ancestry, 1st Line	Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
BG002	Cohort 3 - Non-African Ancestry, 3rd Line+	Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
BG003	Cohort 4 - Non-African Ancestry, 1st Line	Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
BG004	Total	Total of all reporting groups