Efficacy and Safety Study of First-line Treatment With Pe... | NCT03635567

NCT03635567

ID	Type	Description
MK-3475-826	Other Identifier	MSD
KEYNOTE-826	Other Identifier	MSD
184183	Registry Identifier	JAPAC-CTI
2018-001440-53	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pembrolizumab+Chemotherapy	Experimental	On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.	Biological: Pembrolizumab Drug: Paclitaxel Drug: Cisplatin Drug: Carboplatin Biological: Bevacizumab
Placebo+Chemotherapy	Placebo Comparator	On Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.	Drug: Paclitaxel Drug: Cisplatin Drug: Carboplatin Biological: Bevacizumab Drug: Placebo to pembrolizumab

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	IV infusion	Pembrolizumab+Chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥1 is presented.	Up to approximately 46 months
PFS Per RECIST 1.1 as Assessed by Investigator in All Participants	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants is presented.	Up to approximately 46 months
PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥10 is presented.	Up to approximately 46 months

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator	ORR was defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The ORR per RECIST 1.1 as assessed by Investigator is presented.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). Prior chemotherapy utilized as a radiosensitizing agent and completed at least 2 weeks prior to randomization with resolution of all treatment-related toxicities is allowed. AEs due to previous treatments should be resolved to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are eligible.
Not pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab
Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization
Has adequate organ function

Exclusion Criteria:

A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with known brain metastases may participate provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have undergone potentially curative therapy are not excluded.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137)
Has received prior systemic chemotherapy for treatment of cervical cancer.
Has not recovered adequately from toxicity and/or complications from major surgery prior to randomization
Has received prior radiotherapy within 2 weeks prior to randomization. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Has received a live vaccine within 30 days prior to randomization
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days following last dose of pembrolizumab/placebo and 210 days following last dose of chemotherapy/bevacizumab
Has had an allogeneic tissue/solid organ transplant

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alaska Women's Cancer Care ( Site 1770)		Anchorage	Alaska	99508	United States
Arizona Oncology Associates, PC- HAL ( Site 8005)

PubMed Identifier	Type	Citation	Retractions
37910822	Result	Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Keefe SM, Lorusso D; KEYNOTE-826 Investigators. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023 Dec 20;41(36):5505-5511. doi: 10.1200/JCO.23.00914. Epub 2023 Nov 1.
40590325

Label	URL
Merck Clinical Trials Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

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_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 10, 2022

Arm/Group Information

ID	Title	Description
BG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
BG001	Placebo+Chemotherapy	On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00051.7± 11.9 BG00150.7± 12.7 BG00251.2± 12.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000308 BG001309 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000109 BG001121 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00018 BG00121 BG002

Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) Status

Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue. Randomization of participants in the study were stratified by their PD-L1 CPS at baseline (PD-L1 CPS<1, 1≤ PD-L1 CPS<10, or PD-L1 CPS≥10).

Count of Participants

Participants

Title

Denominators

Categories

PD-L1 CPS<1

Title	Measurements
	BG00035 BG001

Metastatic at Initial Diagnosis

Randomization of participants was stratified by whether they were metastatic at initial diagnosis (Yes or No). Metastatic was defined as Stage IVB based on the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) (2009).

Count of Participants

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00094 BG001

Investigator Choice to Use Bevacizumab

Randomization of participants was stratified by the Investigator's choice for the participant to receive bevacizumab (Yes or No).

Count of Participants

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG000196 BG001193

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

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥1 is presented.

All randomized participants with PD-L1 CPS ≥1 based on the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 46 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
OG001	Placebo+Chemotherapy	On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.

Units	Counts
Participants	OG000273 OG001275

Title

Denominators

Categories

Title	Measurements
	OG00010.5(9.7 to 12.3) OG0018.2(6.3 to 8.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Treatment comparison (hazard ratio [HR]) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO [2009] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS<1, CPS 1 to <10, or CPS ≥10).	Stratified Log-Rank	Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO [2009] stage IVB), bevacizumab use, and PD-L1 status.	<0.0001	No formal hypothesis testing performed; nominal p-value provided for treatment comparison.	Hazard Ratio (HR)	0.58			2-Sided	95	0.47	0.71

Primary

PFS Per RECIST 1.1 as Assessed by Investigator in All Participants

All randomized participants based on the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 46 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

Primary

PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10

All randomized participants with PD-L1 CPS ≥10 based on the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 46 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

Primary

Overall Survival (OS) in Participants With PD-L1 CPS ≥1

OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥1 is presented.

All randomized participants with PD-L1 CPS ≥1 based on the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 46 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
OG001	Placebo+Chemotherapy	On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.

Primary

OS in All Participants

OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants is presented.

All randomized participants based on the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 46 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
OG001	Placebo+Chemotherapy	On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.

Primary

OS in Participants With PD-L1 CPS ≥10

OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥10 is presented.

All randomized participants with PD-L1 CPS ≥10 based on the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 46 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
OG001	Placebo+Chemotherapy	On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.

Secondary

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator

ORR was defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The ORR per RECIST 1.1 as assessed by Investigator is presented.

All randomized participants based on the treatment group to which they were randomized.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 46 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
OG001	Placebo+Chemotherapy

Secondary

Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator

For participants who demonstrate CR or PR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by Investigator is presented.

All randomized participants based on the treatment group to which they were randomized who demonstrated CR or PR.

Posted

Median

95% Confidence Interval

Months

Up to approximately 46 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
OG001	Placebo+Chemotherapy	On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.

Secondary

Percentage of Participants That Were PFS Event-Free (PFS Rate) at Month 12 Per RECIST 1.1 as Assessed by Investigator

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS Rate was defined as the percentage of participants that were PFS event-free at Month 12. The PFS Rate per RECIST 1.1 as assessed by Investigator at Month 12 is presented.

All randomized participants based on the treatment group to which they were randomized.

Posted

Number

95% Confidence Interval

Percentage of Participants

12 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

Secondary

PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR)

PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by BICR is presented.

All randomized participants based on the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 46 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is presented.

All randomized participants who received at least one dose of study treatment.

Posted

Number

Number of participants

Up to approximately 66 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
OG001	Placebo+Chemotherapy	On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.

Secondary

Number of Participants Who Experienced a Serious AE (SAE)

An SAE was defined as any untoward medical occurrence that, at any dose: a.) Resulted in death; b.) Was life-threatening; c.) Required inpatient hospitalization or prolongation of existing hospitalization; d.) Resulted in persistent or significant disability/incapacity; e.) Was a congenital anomaly/birth defect; f.) Other important medical events; h.) Was a new cancer (that is not a condition of the study) or i.) Was associated with an overdose. The number of participants who experienced an SAE is presented.

All randomized participants who received at least one dose of study treatment.

Posted

Number

Number of Participants

Up to approximately 66 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

Secondary

Number of Participants Who Experienced an Immune-related AE (irAE)

AEs associated with pembrolizumab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. For this study irAEs included, but were not limited to: -Pneumonitis;

Diarrhea/Colitis;
Aspartate transaminase (AST)/Alanine transaminase (ALT) elevation or Increased bilirubin;
Type 1 diabetes mellitus or Hyperglycemia;
Hypophysitis;
Hyperthyroidism;
Hypothyroidism;
Nephritis and Renal dysfunction; and
Myocarditis. The number of participants who experienced an irAE is presented.

All randomized participants who received at least one dose of study treatment.

Posted

Number

Number of Participants

Up to approximately 66 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

Secondary

Number of Participants Who Discontinued Study Treatment Due to an AE

All randomized participants who received at least one dose of study treatment.

Posted

Number

Number of Participants

Up to approximately 63 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
OG001	Placebo+Chemotherapy	On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.

Secondary

Number of Participants With a 10-point Change From Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Combined Global Score

The EORTC QLQ-C30 is a questionnaire to assess the quality of life of cancer patients. Participant responses to "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) are scored on a 7-point scale (1= Very poor to 7=Excellent). Raw scores are standardized with linear transformation so that scores range from 0-100. A higher combined score indicates a better overall health status. Participant post-baseline scores were classified based on change from baseline, "Improved": a ≥10-point improvement in score and confirmed by the next visit; "Stable": a ≥10-point increase or <10-point change in score OR a <10-point change in score and a ≥10-point increase in score at the next visit; or "Deteriorated": a ≥10-point deterioration in score when the criteria for improvement/stability weren't met. Participants who didn't meet "Improved", "Stable", or "Deteriorated" criteria reported as "Other".

Per protocol, all randomized participants who received at least one dose of study treatment and completed at least one EORTC QLQ-C30 assessment were analyzed. Participants with no EORTC QLQ-C30 assessment were not included in the analysis.

Posted

Number

Number of Participants

Baseline (Cycle 1 Day 1: Predose) and up to approximately 46 months

ID	Title	Description
OG000	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

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	Pembrolizumab+Chemotherapy	On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	195	308	157	307	298	307
EG001	Placebo+Chemotherapy	On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.	241	309	132	309	299	309
EG002	Pembrolizumab (Second Course)	Eligible participants received up to 17 additional administrations (up to approximately 1 year) of pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.	4	12	4	12	8	12

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG00014 events14 affected307 at risk EG00114 events12 affected309 at risk EG0020 events0 affected12 at risk
Bicytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG00025 events21 affected307 at risk EG00114 events13 affected309 at risk EG0020 events0 affected12 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0005 events4 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG0013 events2 affected309 at risk EG0020 events0 affected12 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Bundle branch block	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Cardiac arrest	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Myocarditis	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Hypophysitis	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Optic neuropathy	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Colitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0005 events5 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Ileus	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0014 events1 affected309 at risk EG0020 events0 affected12 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Proctitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Rectal perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Subileus	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Volvulus	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Asthenia	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Chest pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Death	General disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
General physical health deterioration	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Infusion site extravasation	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Malaise	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Medical device site laceration	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Pseudocyst	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0009 events9 affected307 at risk EG0015 events5 affected309 at risk EG0020 events0 affected12 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Immune-mediated cholangitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Anaphylactic shock	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Contrast media allergy	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Hypersensitivity	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Abdominal sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Acute hepatitis B	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Anal abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Bacteraemia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Bronchitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Cystitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Device related infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Diverticulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Empyema	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Erysipelas	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Fournier's gangrene	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Groin abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Herpes zoster	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Herpes zoster meningoradiculitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Infected fistula	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Infected lymphocele	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Pelvic infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Peritonitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0017 events7 affected309 at risk EG0020 events0 affected12 at risk
Psoas abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Pyelonephritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected307 at risk EG0014 events2 affected309 at risk EG0020 events0 affected12 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Pyometra	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0008 events8 affected307 at risk EG0015 events5 affected309 at risk EG0020 events0 affected12 at risk
Septic shock	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00017 events16 affected307 at risk EG00123 events20 affected309 at risk EG0022 events1 affected12 at risk
Urosepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0015 events4 affected309 at risk EG0020 events0 affected12 at risk
Vascular device infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Wound infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0012 events1 affected309 at risk EG0020 events0 affected12 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Post procedural urine leak	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0006 events4 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Urinary tract stoma complication	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Blood pressure increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Liver function test increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Neutrophil count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Platelet count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Urine output decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Weight decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Autoimmune myositis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Ovarian cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Embolic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Encephalitis autoimmune	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Hemiparesis	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Idiopathic intracranial hypertension	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Paraesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Seizure	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Syncope	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Device dislocation	Product Issues	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Device occlusion	Product Issues	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Stent malfunction	Product Issues	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Confusional state	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Delirium	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG00013 events11 affected307 at risk EG0016 events5 affected309 at risk EG0020 events0 affected12 at risk
Bladder diverticulum	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Haematuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0006 events5 affected307 at risk EG0014 events4 affected309 at risk EG0020 events0 affected12 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected307 at risk EG0014 events4 affected309 at risk EG0021 events1 affected12 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Nephropathy	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Postrenal failure	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Renal failure	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Urethral fistula	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Urinoma	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Urogenital fistula	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0005 events5 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Abnormal uterine bleeding	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0008 events8 affected307 at risk EG00110 events10 affected309 at risk EG0021 events1 affected12 at risk
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Vaginal fistula	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0005 events5 affected307 at risk EG0015 events4 affected309 at risk EG0020 events0 affected12 at risk
Vulval ulceration	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected307 at risk EG0016 events6 affected309 at risk EG0020 events0 affected12 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Embolism	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0012 events2 affected309 at risk EG0020 events0 affected12 at risk
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0013 events3 affected309 at risk EG0020 events0 affected12 at risk
Hypertensive urgency	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected309 at risk EG0020 events0 affected12 at risk
Vena cava embolism	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0020 events0 affected12 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG000264 events182 affected307 at risk EG001247 events159 affected309 at risk EG0022 events2 affected12 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG00071 events40 affected307 at risk EG00155 events33 affected309 at risk EG0022 events2 affected12 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG00029 events15 affected307 at risk EG0017 events7 affected309 at risk EG0021 events1 affected12 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG000142 events71 affected307 at risk EG001115 events58 affected309 at risk EG0020 events0 affected12 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG00090 events60 affected307 at risk EG001101 events60 affected309 at risk EG0020 events0 affected12 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0012 events2 affected309 at risk EG0021 events1 affected12 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG00026 events24 affected307 at risk EG00110 events9 affected309 at risk EG0020 events0 affected12 at risk
Hypothyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG00065 events59 affected307 at risk EG00133 events31 affected309 at risk EG0020 events0 affected12 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00066 events50 affected307 at risk EG00178 events52 affected309 at risk EG0020 events0 affected12 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00018 events16 affected307 at risk EG00113 events12 affected309 at risk EG0020 events0 affected12 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00043 events30 affected307 at risk EG00141 events30 affected309 at risk EG0020 events0 affected12 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Colitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00011 events10 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000143 events89 affected307 at risk EG001147 events101 affected309 at risk EG0021 events1 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000203 events111 affected307 at risk EG001174 events93 affected309 at risk EG0021 events1 affected12 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00024 events20 affected307 at risk EG00119 events15 affected309 at risk EG0022 events1 affected12 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00011 events11 affected307 at risk EG00114 events13 affected309 at risk EG0021 events1 affected12 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000265 events122 affected307 at risk EG001287 events135 affected309 at risk EG0021 events1 affected12 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00026 events16 affected307 at risk EG00120 events15 affected309 at risk EG0020 events0 affected12 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00026 events22 affected307 at risk EG00130 events22 affected309 at risk EG0021 events1 affected12 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000127 events81 affected307 at risk EG001142 events85 affected309 at risk EG0021 events1 affected12 at risk
Asthenia	General disorders	MedDRA 27.0	Systematic Assessment	EG000122 events64 affected307 at risk EG001128 events66 affected309 at risk EG0020 events0 affected12 at risk
Facial pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG000148 events88 affected307 at risk EG001150 events85 affected309 at risk EG0020 events0 affected12 at risk
Mucosal inflammation	General disorders	MedDRA 27.0	Systematic Assessment	EG00032 events23 affected307 at risk EG00114 events10 affected309 at risk EG0020 events0 affected12 at risk
Oedema peripheral	General disorders	MedDRA 27.0	Systematic Assessment	EG00038 events32 affected307 at risk EG00136 events30 affected309 at risk EG0020 events0 affected12 at risk
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG00078 events51 affected307 at risk EG00161 events44 affected309 at risk EG0020 events0 affected12 at risk
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected307 at risk EG00114 events13 affected309 at risk EG0021 events1 affected12 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00026 events20 affected307 at risk EG00113 events11 affected309 at risk EG0021 events1 affected12 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00019 events13 affected307 at risk EG00121 events16 affected309 at risk EG0020 events0 affected12 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG000123 events67 affected307 at risk EG001111 events74 affected309 at risk EG0020 events0 affected12 at risk
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0008 events8 affected307 at risk EG0013 events3 affected309 at risk EG0021 events1 affected12 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG00024 events17 affected307 at risk EG00117 events12 affected309 at risk EG0020 events0 affected12 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG00067 events45 affected307 at risk EG00137 events29 affected309 at risk EG0023 events3 affected12 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG00057 events35 affected307 at risk EG00132 events24 affected309 at risk EG0023 events3 affected12 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG00033 events27 affected307 at risk EG00120 events18 affected309 at risk EG0021 events1 affected12 at risk
Blood creatinine increased	Investigations	MedDRA 27.0	Systematic Assessment	EG00044 events28 affected307 at risk EG00142 events34 affected309 at risk EG0020 events0 affected12 at risk
Neutrophil count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG000152 events56 affected307 at risk EG001143 events48 affected309 at risk EG0020 events0 affected12 at risk
Platelet count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG00099 events49 affected307 at risk EG00169 events42 affected309 at risk EG0021 events1 affected12 at risk
Weight decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG00035 events35 affected307 at risk EG00138 events37 affected309 at risk EG0020 events0 affected12 at risk
White blood cell count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG000109 events37 affected307 at risk EG00162 events22 affected309 at risk EG0021 events1 affected12 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00097 events62 affected307 at risk EG00177 events52 affected309 at risk EG0021 events1 affected12 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00019 events13 affected307 at risk EG00128 events19 affected309 at risk EG0021 events1 affected12 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00019 events18 affected307 at risk EG00111 events11 affected309 at risk EG0021 events1 affected12 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00043 events30 affected307 at risk EG00134 events29 affected309 at risk EG0021 events1 affected12 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00038 events27 affected307 at risk EG00131 events19 affected309 at risk EG0020 events0 affected12 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00027 events21 affected307 at risk EG00116 events15 affected309 at risk EG0020 events0 affected12 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0004 events3 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG000128 events82 affected307 at risk EG001126 events78 affected309 at risk EG0020 events0 affected12 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00055 events44 affected307 at risk EG00164 events48 affected309 at risk EG0020 events0 affected12 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00022 events21 affected307 at risk EG00122 events18 affected309 at risk EG0020 events0 affected12 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00098 events57 affected307 at risk EG001115 events61 affected309 at risk EG0021 events1 affected12 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00060 events38 affected307 at risk EG00152 events27 affected309 at risk EG0020 events0 affected12 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00027 events22 affected307 at risk EG00133 events26 affected309 at risk EG0020 events0 affected12 at risk
Dysgeusia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00017 events15 affected307 at risk EG00124 events20 affected309 at risk EG0020 events0 affected12 at risk
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00076 events50 affected307 at risk EG00199 events57 affected309 at risk EG0020 events0 affected12 at risk
Migraine	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0011 events1 affected309 at risk EG0021 events1 affected12 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG000105 events81 affected307 at risk EG00197 events80 affected309 at risk EG0020 events0 affected12 at risk
Paraesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00038 events28 affected307 at risk EG00134 events26 affected309 at risk EG0020 events0 affected12 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00081 events70 affected307 at risk EG00189 events78 affected309 at risk EG0020 events0 affected12 at risk
Anxiety	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG00016 events16 affected307 at risk EG00114 events13 affected309 at risk EG0020 events0 affected12 at risk
Insomnia	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG00035 events34 affected307 at risk EG00129 events27 affected309 at risk EG0022 events2 affected12 at risk
Dysuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG00027 events22 affected307 at risk EG00129 events23 affected309 at risk EG0020 events0 affected12 at risk
Haematuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG00025 events20 affected307 at risk EG00120 events15 affected309 at risk EG0020 events0 affected12 at risk
Incontinence	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0004 events3 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Leukocyturia	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0008 events5 affected307 at risk EG0011 events1 affected309 at risk EG0022 events2 affected12 at risk
Proteinuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG00087 events54 affected307 at risk EG00152 events33 affected309 at risk EG0020 events0 affected12 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG00018 events16 affected307 at risk EG00139 events33 affected309 at risk EG0020 events0 affected12 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG00018 events17 affected307 at risk EG00126 events24 affected309 at risk EG0020 events0 affected12 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG00040 events25 affected307 at risk EG00140 events32 affected309 at risk EG0021 events1 affected12 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG00048 events40 affected307 at risk EG00141 events32 affected309 at risk EG0021 events1 affected12 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG00028 events22 affected307 at risk EG00134 events30 affected309 at risk EG0021 events1 affected12 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG00053 events31 affected307 at risk EG00165 events43 affected309 at risk EG0021 events1 affected12 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected309 at risk EG0021 events1 affected12 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG000173 events173 affected307 at risk EG001181 events179 affected309 at risk EG0020 events0 affected12 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0008 events5 affected307 at risk EG0017 events6 affected309 at risk EG0021 events1 affected12 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00018 events18 affected307 at risk EG00110 events9 affected309 at risk EG0020 events0 affected12 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00058 events40 affected307 at risk EG00139 events26 affected309 at risk EG0020 events0 affected12 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00066 events47 affected307 at risk EG00148 events36 affected309 at risk EG0022 events2 affected12 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00020 events16 affected307 at risk EG00113 events9 affected309 at risk EG0022 events1 affected12 at risk
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG000117 events80 affected307 at risk EG001117 events71 affected309 at risk EG0020 events0 affected12 at risk

ID	Term
D002583	Uterine Cervical Neoplasms
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

ID	Term
C582435	pembrolizumab
D017239	Paclitaxel
D002945	Cisplatin
D016190	Carboplatin
D000068258	Bevacizumab
D000077330	Saline Solution