Rollover Study in Participants With Metastatic Solid Tumo... | NCT04319198

NCT04319198

ID	Type	Description	Link
2023-505336-34	Other Identifier	European Medicines Agency

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)	Experimental	All participants who previously received SG in the parent study (IMMU-132-01) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Drug: Sacituzumab Govitecan-hiy
Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)	Experimental	All participants who previously received SG in the parent study (IMMU-132-05) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Drug: Sacituzumab Govitecan-hiy
Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15)	Experimental	All participants who previously received SG in the parent study (IMMU-132-15) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	Drug: Sacituzumab Govitecan-hiy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sacituzumab Govitecan-hiy	Drug	Administered intravenously	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Experiencing Any Adverse Events	An adverse event was defined as any untoward medical occurrence in a participant administered a medicinal product that does not necessarily have a causal relationship with this treatment.	First dose date up to 30 days post last dose (Up to 3.9 years)
Percentage of Participants Experiencing Any Serious Adverse Events	A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, was fatal (resulting in death), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.	First dose date up to 30 days post last dose (Up to 3.9 years)
Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities	The percentage of participants experiencing any clinically significant laboratory abnormality was summarized.	First dose date up to 30 days post last dose (Up to 3.9 years)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Francisco		San Francisco	California	94143	United States
Rocky Mountain Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35728046	Derived	Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.

Label	URL
Gilead Clinical Trials Website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)	All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 27, 2021	Aug 14, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15)

All Treated Participants Analysis Set included all participants who received ≥ 1 dose of study drug following enrollment into this rollover IMMU-132-14 study.

Arm/Group Information

ID	Title	Description
BG000	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)	All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
BG001	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)	All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
BG002	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15)	All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG00110 BG00212 BG00325

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00071± 5.7 BG00161± 10.4 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG00110 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Belgium

Title	Measurements
	BG0000 BG0012 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Experiencing Any Adverse Events

An adverse event was defined as any untoward medical occurrence in a participant administered a medicinal product that does not necessarily have a causal relationship with this treatment.

Participants from All Treated Participants Analysis Set were analyzed.

Posted

Number

percentage of participants

First dose date up to 30 days post last dose (Up to 3.9 years)

ID	Title	Description
OG000	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)	All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
OG001	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)	All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
OG002	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15)	All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.

Units	Counts
Participants	OG0003 OG00110 OG00212

Title

Denominators

Categories

Title	Measurements
	OG00066.7 OG001100.0 OG00291.7

Primary

Percentage of Participants Experiencing Any Serious Adverse Events

A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, was fatal (resulting in death), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.

Participants from All Treated Participants Analysis Set were analyzed.

Posted

Number

percentage of participants

First dose date up to 30 days post last dose (Up to 3.9 years)

ID	Title	Description
OG000	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)	All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
OG001	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)	All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.

Primary

Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities

The percentage of participants experiencing any clinically significant laboratory abnormality was summarized.

Participants from All Treated Participants Analysis Set with at least 1 grade change postbaseline were analyzed.

Posted

Number

percentage of participants

First dose date up to 30 days post last dose (Up to 3.9 years)

ID	Title	Description
OG000	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)	All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
OG001	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)	All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.

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	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)	All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	0	3	0	3	2	3
EG001	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)	All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	3	10	4	10	10	10
EG002	Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15)	All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.	3	12	1	12	11	12

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Covid-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Lymphoedema	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected3 at risk EG0014 affected10 at risk EG0022 affected12 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0022 affected12 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected3 at risk EG0014 affected10 at risk EG0024 affected12 at risk
Neutrophilia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Palpitations	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected10 at risk EG0020 affected12 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0020 affected12 at risk
Blepharospasm	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Dry eye	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Erythema of eyelid	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Visual impairment	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Vitreous floaters	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0014 affected10 at risk EG0023 affected12 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0021 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected3 at risk EG0016 affected10 at risk EG0022 affected12 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected10 at risk EG0020 affected12 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0016 affected10 at risk EG0023 affected12 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Axillary pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Chest discomfort	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Chills	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Facial pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0014 affected10 at risk EG0022 affected12 at risk
Gait disturbance	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Mucosal inflammation	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Non-cardiac chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0021 affected12 at risk
Vaccination site pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Bronchitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Candida infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0020 affected12 at risk
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0020 affected12 at risk
Cellulitis orbital	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Covid-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected10 at risk EG0021 affected12 at risk
Eye infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Hordeolum	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Oral candidiasis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Rash pustular	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0021 affected12 at risk
Sinusitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected10 at risk EG0020 affected12 at risk
Skin infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected10 at risk EG0021 affected12 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Injection related reaction	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Blood bicarbonate decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Blood bilirubin increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Blood glucose increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Lymphocyte count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Neutrophil count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0021 affected12 at risk
Weight decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
White blood cell count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected10 at risk EG0020 affected12 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected3 at risk EG0013 affected10 at risk EG0021 affected12 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0021 affected12 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected10 at risk EG0020 affected12 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0020 affected12 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0020 affected12 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0020 affected12 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected3 at risk EG0012 affected10 at risk EG0020 affected12 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0020 affected12 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected10 at risk EG0020 affected12 at risk
Sacral pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Aphasia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Brain fog	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Coordination abnormal	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Encephalopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0014 affected10 at risk EG0020 affected12 at risk
Migraine	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Paraesthesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Paralysis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0022 affected12 at risk
Sciatica	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Syncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Tremor	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Visuospatial deficit	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Device deposit issue	Product Issues	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Device occlusion	Product Issues	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Anxiety	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Confusional state	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Depression	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0021 affected12 at risk
Insomnia	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Mental status changes	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Dysuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Haematuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0021 affected12 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0023 affected12 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0020 affected12 at risk
Nocturnal dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0024 affected12 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected10 at risk EG0020 affected12 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0021 affected12 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected10 at risk EG0021 affected12 at risk
Flushing	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Hot flush	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Iliac artery disease	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk
Lymphoedema	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected10 at risk EG0020 affected12 at risk

ID	Term
C000608132	sacituzumab govitecan