Phase 3 Study of Nemvaleukin Alfa in Combination With Pem... | NCT05092360

NCT05092360

ID	Type	Description
GOG-3063	Other Identifier	The GOG Foundation
ENGOT-OV68	Other Identifier	European Network Gynaecological Oncological Trial groups
KEYNOTE-C71	Other Identifier	Merck
APGOT-OV8	Other Identifier	APAC Gynecologic Oncology Trial Group

Status Module

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Description 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
Nemvaleukin and Pembrolizumab Combination	Experimental		Biological: Nemvaleukin and Pembrolizumab Combination
Pembrolizumab (enrollment completed)	Experimental		Biological: Pembrolizumab
Nemvaleukin (enrollment completed)	Experimental		Biological: Nemvaleukin
Investigator's Choice	Active Comparator	Options for protocol-specific Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator will pre-select the Investigator's choice treatment before the randomization of each patient.	Drug: Pegylated Liposomal Doxorubicin (PLD) Drug: Paclitaxel Drug: Topotecan Drug: Gemcitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nemvaleukin and Pembrolizumab Combination	Biological	Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes and Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes

Outcomes Module

Measure	Description	Time Frame
Overall Survival (OS)	Estimates based on Kaplan-Meier method.	From the first dose of study drug up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) as Assessed by Investigator	Response is based on RECIST v1.1 criteria.	From the first dose of study drug up to 20 months
Disease Control Rate (DCR) as Assessed by Investigator

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is female and ≥18 years of age.
Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.
Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.
Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting, and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant setting. Patient must have received at least 1 line of therapy containing bevacizumab.
Patient has at least one measurable lesion that qualifies as a target lesion based on RECISTv1.1.
Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifying archival tumor tissue.

Exclusion Criteria:

Patient has primary platinum-refractory disease or primary platinum resistance, defined as disease progression during first-line platinum-based therapy (refractory) or disease progression <3 months after completion of first-line platinum-based therapy (resistant).
Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.
Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor).
Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis) of ≥500 mL within 4 weeks of first dose of study drug.
Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.
Patient has prior exposure to any anti-PD1/PD-L1 therapy.

Name	Affiliation	Role
Mural Oncology Medical Monitor	Mural Oncology, Inc	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35216	United States
Alaska Women's Cancer Care

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37334673	Derived	Herzog TJ, Hays JL, Barlin JN, Buscema J, Cloven NG, Kong LR, Tyagi NK, Lanneau GS, Long BJ, Marsh RL, Seward SM, Starks DC, Welch S, Moore KN, Konstantinopoulos PA, Gilbert L, Monk BJ, O'Malley DM, Chen X, Dalal R, Coleman RL, Sehouli J. ARTISTRY-7: phase III trial of nemvaleukin alfa plus pembrolizumab vs chemotherapy for platinum-resistant ovarian cancer. Future Oncol. 2023 Jul;19(23):1577-1591. doi: 10.2217/fon-2023-0246. Epub 2023 Jun 19.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
FG001	Pembrolizumab 200 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 31, 2024	Jun 26, 2025

Arm/Group Information

ID	Title	Description
BG000	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
BG001	Pembrolizumab 200 mg	Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
BG002	Nemvaleukin 6 mcg/kg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
BG003	Investigator's Choice Chemotherapy	Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant. Pegylated Liposomal Doxorubicin (PLD): 40 mg/m^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel: 80 mg/m^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan: 4 mg/m^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min. Gemcitabine: 1,000 mg/m^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062.6± 8.83 BG00161.6± 12.97 BG00261.5± 9.17 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000184 BG00127 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0008 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0011 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

Overall Survival (OS)

Estimates based on Kaplan-Meier method.

ITT population.

Posted

Median

95% Confidence Interval

months

From the first dose of study drug up to 24 months

ID	Title	Description
OG000	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG001	Pembrolizumab 200 mg	Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG002	Nemvaleukin 6 mcg/kg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
OG003	Investigator's Choice Chemotherapy	Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant. Pegylated Liposomal Doxorubicin (PLD): 40 mg/m^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel: 80 mg/m^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan: 4 mg/m^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min. Gemcitabine: 1,000 mg/m^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.

Units	Counts
Participants	OG000184 OG00127 OG00255 OG003

Title

Denominators

Categories

Title	Measurements
	OG00010.1(7.4 to 12.5) OG00110.1(4.0 to NA)Higher limit of 95% CI could not be assessed due to the limited number of participants and death events within this reporting group. OG002

Secondary

Objective Response Rate (ORR) as Assessed by Investigator

Response is based on RECIST v1.1 criteria.

ITT population.

Posted

Number

95% Confidence Interval

percentage of participants

From the first dose of study drug up to 20 months

ID	Title	Description
OG000	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG001	Pembrolizumab 200 mg	Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG002	Nemvaleukin 6 mcg/kg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
OG003	Investigator's Choice Chemotherapy	Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant. Pegylated Liposomal Doxorubicin (PLD): 40 mg/m^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel: 80 mg/m^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan: 4 mg/m^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min. Gemcitabine: 1,000 mg/m^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.

Secondary

Disease Control Rate (DCR) as Assessed by Investigator

Response is based on RECIST v1.1 criteria.

ITT population.

Posted

Number

95% Confidence Interval

percentage of participants

From the first dose of study drug up to 20 months

ID	Title	Description
OG000	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG001	Pembrolizumab 200 mg	Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG002	Nemvaleukin 6 mcg/kg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
OG003	Investigator's Choice Chemotherapy	Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant. Pegylated Liposomal Doxorubicin (PLD): 40 mg/m^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel: 80 mg/m^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan: 4 mg/m^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min. Gemcitabine: 1,000 mg/m^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.

Secondary

Duration of Response (DOR) as Assessed by Investigator

Response is based on RECIST v1.1 criteria.

ITT population. Here N refers to number of participants with response and were analyzed for this outcome measure.

Posted

Median

Full Range

months

From the first dose of study drug up to 20 months

ID	Title	Description
OG000	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG001	Pembrolizumab 200 mg	Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG002	Nemvaleukin 6 mcg/kg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
OG003	Investigator's Choice Chemotherapy	Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant. Pegylated Liposomal Doxorubicin (PLD): 40 mg/m^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel: 80 mg/m^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan: 4 mg/m^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min. Gemcitabine: 1,000 mg/m^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.

Secondary

Time to Response (TTR) as Assessed by Investigator

Response is based on RECIST v1.1 criteria.

ITT population. Here N refers to number of participants with response and were analyzed for this outcome measure.

Posted

Median

Full Range

months

From the first dose of study drug up to 20 months

ID	Title	Description
OG000	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG001	Pembrolizumab 200 mg	Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG002	Nemvaleukin 6 mcg/kg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
OG003	Investigator's Choice Chemotherapy	Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant. Pegylated Liposomal Doxorubicin (PLD): 40 mg/m^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel: 80 mg/m^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan: 4 mg/m^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min. Gemcitabine: 1,000 mg/m^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.

Secondary

Percentage of Participants With Cancer Antigen (CA)-125 Response as Defined by the Gynecologic Cancer Inter Group (GCIG)

A Cancer Antigen-125 response is defined as at least a 50% reduction in CA-125 levels from baseline, and the response must be confirmed and maintained for at least 28 days as per the GCIG.

ITT population.

Posted

Number

95% Confidence Interval

percentage of participants

From the first dose of study drug up to 20 months

ID	Title	Description
OG000	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG001	Pembrolizumab 200 mg	Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG002	Nemvaleukin 6 mcg/kg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
OG003	Investigator's Choice Chemotherapy

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Safety Set population.

Posted

Count of Participants

Participants

From first dose of study drug up to 90 days after last dose (up to 23 months)

ID	Title	Description
OG000	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG001	Pembrolizumab 200 mg	Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG002	Nemvaleukin 6 mcg/kg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
OG003	Investigator's Choice Chemotherapy	Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant. Pegylated Liposomal Doxorubicin (PLD): 40 mg/m^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel: 80 mg/m^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan: 4 mg/m^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min. Gemcitabine: 1,000 mg/m^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.

Secondary

Progression-free Survival (PFS) as Assessed by Investigator

ITT population.

Posted

Median

95% Confidence Interval

months

From the first dose of study drug up to 20 months

ID	Title	Description
OG000	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG001	Pembrolizumab 200 mg	Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
OG002	Nemvaleukin 6 mcg/kg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
OG003	Investigator's Choice Chemotherapy	Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant. Pegylated Liposomal Doxorubicin (PLD): 40 mg/m^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel: 80 mg/m^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan: 4 mg/m^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min. Gemcitabine: 1,000 mg/m^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.

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	Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.	104	184	74	184	177	184
EG001	Pembrolizumab 200 mg	Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.	15	27	8	27	23	27
EG002	Nemvaleukin 6 mcg/kg	Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.	34	55	17	55	51	55
EG003	Investigator's Choice Chemotherapy	Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant. Pegylated Liposomal Doxorubicin (PLD): 40 mg/m^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel: 80 mg/m^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan: 4 mg/m^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min. Gemcitabine: 1,000 mg/m^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.	105	190	51	190	171	190

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG0031 events1 affected190 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Myocarditis	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Palpitations	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Pericarditis	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0004 events4 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0005 events5 affected184 at risk EG0011 events1 affected27 at risk EG0020 events0 affected55 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0002 events2 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Duodenal obstruction	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected27 at risk EG0020 events0 affected55 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0003 events3 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0006 events6 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Intestinal stenosis	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Malignant gastrointestinal obstruction	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Rectal perforation	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0003 events3 affected184 at risk EG0011 events1 affected27 at risk EG0020 events0 affected55 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected27 at risk EG0020 events0 affected55 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0006 events6 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Chest discomfort	General disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Fatigue	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
General physical health deterioration	General disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0022 events2 affected55 at risk EG003
Localised oedema	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Malaise	General disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Oedema peripheral	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Pain	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Pyrexia	General disorders	MedDRA (27.0)	Systematic Assessment	EG0004 events4 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA (27.0)	Systematic Assessment	EG0002 events2 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0011 events1 affected27 at risk EG0020 events0 affected55 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0007 events7 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Bacteraemia	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Biliary tract infection	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
COVID-19	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Catheter site infection	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Cellulitis	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Diverticulitis	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Empyema	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Enterobacter sepsis	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Erysipeloid	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Infection	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Influenza	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Pneumonia	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0002 events2 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Pulmonary sepsis	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Pyelonephritis	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Salmonella sepsis	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Sepsis	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0002 events2 affected184 at risk EG0011 events1 affected27 at risk EG0021 events1 affected55 at risk EG003
Septic shock	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Urinary tract infection	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Wound infection bacterial	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0002 events2 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected27 at risk EG0020 events0 affected55 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0002 events2 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Blood bilirubin increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0011 events1 affected27 at risk EG0020 events0 affected55 at risk EG003
C-reactive protein increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Liver function test increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Neutrophil count decreased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Platelet count decreased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0002 events2 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Intestinal metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Dizziness	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Memory impairment	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected27 at risk EG0020 events0 affected55 at risk EG003
Seizure	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0003 events3 affected184 at risk EG0011 events1 affected27 at risk EG0022 events2 affected55 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Renal injury	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0004 events4 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Malignant pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0006 events6 affected184 at risk EG0013 events3 affected27 at risk EG0020 events0 affected55 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Pulmonary venous thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected27 at risk EG0020 events0 affected55 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Capillary leak syndrome	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Hypertension	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Lymphocele	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Subclavian vein thrombosis	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Vasculitis	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Vena cava thrombosis	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG000102 events53 affected184 at risk EG0013 events3 affected27 at risk EG00231 events15 affected55 at risk EG003165 events64 affected190 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG00023 events7 affected184 at risk EG0011 events1 affected27 at risk EG00230 events7 affected55 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG00060 events27 affected184 at risk EG0010 events0 affected27 at risk EG00212 events5 affected55 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG000180 events53 affected184 at risk EG0010 events0 affected27 at risk EG00265 events16 affected55 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG00056 events25 affected184 at risk EG0011 events1 affected27 at risk EG00216 events8 affected55 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0005 events4 affected184 at risk EG0010 events0 affected27 at risk EG0026 events5 affected55 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG00021 events17 affected184 at risk EG0010 events0 affected27 at risk EG0023 events3 affected55 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG00040 events35 affected184 at risk EG0014 events4 affected27 at risk EG00218 events13 affected55 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG00013 events10 affected184 at risk EG0011 events1 affected27 at risk EG0021 events1 affected55 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG00016 events11 affected184 at risk EG0011 events1 affected27 at risk EG00211 events6 affected55 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG00045 events35 affected184 at risk EG0012 events2 affected27 at risk EG00216 events12 affected55 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG00055 events41 affected184 at risk EG0013 events3 affected27 at risk EG00216 events9 affected55 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0008 events8 affected184 at risk EG0010 events0 affected27 at risk EG0023 events3 affected55 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG000101 events71 affected184 at risk EG0013 events3 affected27 at risk EG00236 events20 affected55 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG00011 events8 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG00069 events45 affected184 at risk EG0011 events1 affected27 at risk EG00232 events22 affected55 at risk EG003
Asthenia	General disorders	MedDRA (27.0)	Systematic Assessment	EG00050 events37 affected184 at risk EG0010 events0 affected27 at risk EG00231 events15 affected55 at risk EG003
Chills	General disorders	MedDRA (27.0)	Systematic Assessment	EG000162 events61 affected184 at risk EG0011 events1 affected27 at risk EG00230 events15 affected55 at risk EG003
Fatigue	General disorders	MedDRA (27.0)	Systematic Assessment	EG00080 events51 affected184 at risk EG0014 events4 affected27 at risk EG00215 events13 affected55 at risk EG003
Mucosal inflammation	General disorders	MedDRA (27.0)	Systematic Assessment	EG0003 events3 affected184 at risk EG0010 events0 affected27 at risk EG0022 events2 affected55 at risk EG003
Oedema peripheral	General disorders	MedDRA (27.0)	Systematic Assessment	EG00035 events28 affected184 at risk EG0011 events1 affected27 at risk EG0026 events6 affected55 at risk EG003
Pyrexia	General disorders	MedDRA (27.0)	Systematic Assessment	EG000193 events81 affected184 at risk EG0011 events1 affected27 at risk EG00260 events19 affected55 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA (27.0)	Systematic Assessment	EG000176 events37 affected184 at risk EG0010 events0 affected27 at risk EG00229 events10 affected55 at risk EG003
COVID-19	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG00011 events11 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG00015 events13 affected184 at risk EG0014 events4 affected27 at risk EG0024 events4 affected55 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG00088 events31 affected184 at risk EG0010 events0 affected27 at risk EG00237 events12 affected55 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG00094 events52 affected184 at risk EG0012 events2 affected27 at risk EG00253 events20 affected55 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG000116 events62 affected184 at risk EG0011 events1 affected27 at risk EG00256 events21 affected55 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG00029 events18 affected184 at risk EG0012 events2 affected27 at risk EG00215 events10 affected55 at risk EG003
Blood bilirubin increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0006 events4 affected184 at risk EG0010 events0 affected27 at risk EG00211 events6 affected55 at risk EG003
Blood creatinine increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG00013 events9 affected184 at risk EG0011 events1 affected27 at risk EG0026 events3 affected55 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG00030 events14 affected184 at risk EG0012 events1 affected27 at risk EG00239 events9 affected55 at risk EG003
White blood cell count decreased	Investigations	MedDRA (27.0)	Systematic Assessment	EG00034 events13 affected184 at risk EG0010 events0 affected27 at risk EG00211 events4 affected55 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG00036 events31 affected184 at risk EG0010 events0 affected27 at risk EG00213 events10 affected55 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0003 events2 affected184 at risk EG0011 events1 affected27 at risk EG0025 events3 affected55 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG00032 events17 affected184 at risk EG0011 events1 affected27 at risk EG00214 events6 affected55 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG00016 events11 affected184 at risk EG0011 events1 affected27 at risk EG0028 events5 affected55 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG00025 events16 affected184 at risk EG0014 events2 affected27 at risk EG0023 events2 affected55 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG00013 events7 affected184 at risk EG0012 events1 affected27 at risk EG00212 events5 affected55 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG00013 events11 affected184 at risk EG0010 events0 affected27 at risk EG0023 events2 affected55 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG00019 events15 affected184 at risk EG0014 events4 affected27 at risk EG0025 events5 affected55 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG00014 events12 affected184 at risk EG0011 events1 affected27 at risk EG0024 events4 affected55 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG00022 events19 affected184 at risk EG0010 events0 affected27 at risk EG0024 events4 affected55 at risk EG003
Dizziness	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG00022 events15 affected184 at risk EG0011 events1 affected27 at risk EG0027 events5 affected55 at risk EG003
Headache	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG00031 events25 affected184 at risk EG0011 events1 affected27 at risk EG00212 events9 affected55 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 events0 affected184 at risk EG0010 events0 affected27 at risk EG0021 events1 affected55 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0007 events7 affected184 at risk EG0010 events0 affected27 at risk EG0022 events2 affected55 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA (27.0)	Systematic Assessment	EG0005 events4 affected184 at risk EG0010 events0 affected27 at risk EG0023 events3 affected55 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG00013 events12 affected184 at risk EG0012 events2 affected27 at risk EG0021 events1 affected55 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG00040 events27 affected184 at risk EG0017 events5 affected27 at risk EG0024 events3 affected55 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0005 events5 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0006 events3 affected184 at risk EG0011 events1 affected27 at risk EG0023 events3 affected55 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0003 events3 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG00018 events15 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0009 events9 affected184 at risk EG0011 events1 affected27 at risk EG0022 events2 affected55 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG00020 events9 affected184 at risk EG0010 events0 affected27 at risk EG0020 events0 affected55 at risk EG003
Hypertension	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG00035 events10 affected184 at risk EG0013 events1 affected27 at risk EG0023 events3 affected55 at risk EG003
Hypotension	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG00032 events13 affected184 at risk EG0011 events1 affected27 at risk EG0025 events5 affected55 at risk EG003

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D004224	Diterpenes
D013729	Terpenes
D004467	Economics
D004472	Health Care Economics and Organizations
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

ID	Term
D005185	Fallopian Tube Neoplasms
D010051	Ovarian Neoplasms

ID	Term
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005184	Fallopian Tube Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D004701	Endocrine Gland Neoplasms
D010049	Ovarian Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders

ID	Term
C582435	pembrolizumab
C506643	liposomal doxorubicin
D004317	Doxorubicin
D017239	Paclitaxel
D013660	Taxes
D019772	Topotecan
D000093542	Gemcitabine