Lenvatinib in Combination With Pembrolizumab Versus Treat... | NCT03517449

ID	Type	Description	Link
2017-004387-35	EudraCT Number
MK3475-775	Other Identifier	Merck Protocol Number

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Label	Type	Description	Intervention Names
Lenvatinib 20 mg + Pembrolizumab 200 mg	Experimental	Participants will receive pembrolizumab 200 milligram (mg) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus lenvatinib 20 mg administered orally (PO) once daily (QD) during each 21-day cycle for up to 35 cycles.	Drug: Pembrolizumab Drug: Lenvatinib
Treatment of Physician's Choice	Active Comparator	Participants will receive either of the following treatments: doxorubicin 60 milligram per square meter (mg/m^2) administered by IV on Day 1 of each 21-day cycle for up to a maximum cumulative dose of 500 mg/m^2 OR paclitaxel 80 mg/m^2 administered by IV on a 28-day cycle: 3 weeks receiving paclitaxel once a week and 1 week not receiving paclitaxel.	Drug: Paclitaxel Drug: Doxorubicin

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Drug	200 mg administered by IV infusion on Day 1 of each 21-day cycle.	Lenvatinib 20 mg + Pembrolizumab 200 mg

Measure	Description	Time Frame
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants	PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.	Up to approximately 27 months
PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants	PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.	Up to approximately 27 months
Overall Survival (OS) in pMMR Participants	OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first.	Up to approximately 43 months

Measure	Description	Time Frame
Objective Response Rate (ORR) in pMMR Participants	ORR was defined as the percentage of participants who had best overall response of either complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Name	Affiliation	Role
Medical Director	Eisai Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Oncology Associates, PC- HAL		Phoenix	Arizona	85016	United States
University of California San Francisco

PubMed Identifier	Type	Citation	Retractions
42167105	Derived	Marth C, Lorusso D, Bidzinski M, Scollo P, Vardar MA, Oaknin A, Kaen DL, Nogueira-Rodrigues A, Miller DS, Hasegawa K, MacKay H, Moore RG, Santin AD, Yunokawa M, Romero I, Pignata S, Baron-Hay S, Kim YM, Amit A, Ghamande S, Danska-Bidzinska A, Tarnawski R, Wang PH, Yu Z, Slomovitz BM, Okpara CE, McKenzie J, Meng R, Orlowski R, Makker V. Lenvatinib plus pembrolizumab in participants with advanced or recurrent endometrial cancer: Study 309/KEYNOTE-775 and ENGOT-en9/LEAP-001 post-(neo)adjuvant therapy outcomes. Int J Gynecol Cancer. 2026 Apr 12;36(7):104693. doi: 10.1016/j.ijgc.2026.104693. Online ahead of print.
38302725

ID	Title	Description
FG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 30, 2022	Feb 26, 2026

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) Based on Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants

PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.

Analysis population consisted of ITT (intent to treat) population which included all randomized participants. Data is reported for pMMR participants.

Posted

Median

95% Confidence Interval

Months

Up to approximately 27 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
OG001	Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

Units	Counts
Participants	OG000346 OG001351

Title

Denominators

Categories

Title	Measurements
	OG0006.6± 5.6(5.6 to 7.4) OG0013.8± 3.6(3.6 to 5.0)

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		Log Rank		< 0.0001	One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region, and prior history of pelvic radiation.	Hazard Ratio (HR)	0.60			2-Sided	95	0.50	0.72			Regression, Cox method		Superiority

Primary

PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants

Analysis population consisted of ITT population which included all randomized participants.

Posted

Median

95% Confidence Interval

Months

Up to approximately 27 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
OG001	Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel

Primary

Overall Survival (OS) in pMMR Participants

OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first.

Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants.

Posted

Median

95% Confidence Interval

Months

Up to approximately 43 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
OG001	Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

Primary

OS in All-comer Participants

Analysis population consisted of ITT population which included all randomized participants.

Posted

Number

95% Confidence Interval

Months

Up to approximately 43 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
OG001	Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

Secondary

Objective Response Rate (ORR) in pMMR Participants

ORR was defined as the percentage of participants who had best overall response of either complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 80 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
OG001	Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

Secondary

ORR in All-comer Participants

Analysis population consisted of ITT population which included all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 80 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
OG001	Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

Secondary

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) in pMMR Participants

EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.

Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

95% Confidence Interval

Score on a scale

Baseline, Week 12

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study

Secondary

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) in All-comer Participants

Analysis population consisted of ITT population which included all randomized participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

95% Confidence Interval

Score on a scale

Baseline, Week 12

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study

Secondary

Number of Partricipants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (irAEs)

TEAEs were AEs that occurred (or worsened, if present at baseline) after the first dose of study drug through 28 days after the last dose. An AE was any untoward medical occurrence in a participant temporally associated with use of study treatment, whether or not related to the treatment. An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital anomaly/birth defect. An irAE was any unfavorable and unintended immune-related sign, symptom, or disease (new or worsening) temporally associated with study therapy, regardless of whether a causal relationship with the therapy could be determined.

The analysis population included all randomized participants who received at least 1 dose of study treatment.

Posted

Count of Participants

Participants

Up to approximately 77 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study

Secondary

Number of Participants Who Discontinued Study Treatment Due to a TEAE in pMMR Participants

TEAEs was defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Safety analysis population included all randomized participants who received at least 1 dose of study treatment. Data is reported for pMMR participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Posted

Count of Participants

Participants

Up to approximately 77 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
OG001	Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

Secondary

Number of Participants Who Discontinued Study Treatment Due to a TEAE in All-comer Participants

Safety analysis population included all randomized participants who received at least 1 dose of study treatment.

Posted

Count of Participants

Participants

Up to approximately 77 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
OG001	Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

Secondary

Time to Treatment Failure Due to Toxicity in pMMR Participants

Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date a participant discontinued study treatment due to TEAEs.

Posted

Geometric Mean

Standard Deviation

Months

Up to approximately 77 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
OG001	Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

Secondary

Time to Treatment Failure Due to Toxicity in All-comer Participants

Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date a participant discontinued study treatment due to TEAEs.

Safety analysis population included all randomized participants who received at least 1 dose of study treatment.

Posted

Geometric Mean

Standard Deviation

Months

Up to approximately 77 months

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
OG001	Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

Secondary

Plasma Concentration of Lenvatinib Versus Time in All-comer Participants

Pharmacokinetic (PK) samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted plasma concentration of lenvatinib was then derived from the PK model.

Analysis population included all participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm and have measurable plasma levels of lenvatinib. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific timepoints.

Posted

Mean

Standard Deviation

nanograms per milliliter (ng/mL)

Cycle 1 day 1 0.5-4 hours (h), 6-10 postdose; Cycle 1 day 15 predose; Cycle 1 day 15 2-12h postdose, Cycle 2 day 1 predose, 0.5-4h, 6-10 h (Each cycle is 21 days)

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study

Units	Counts

Secondary

Plasma Concentration of Lenvatinib Versus Time in pMMR Participants

PK samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted plasma concentration of lenvatinib was then derived from the PK model.

Analysis population included all participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm and have measurable plasma levels of lenvatinib. Data is reported for pMMR participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific timepoints.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1 day 1 0.5-4 hour (h), 6-10 postdose; Cycle 1 day 15 predose; Cycle 1 day 15 2-12h postdose, Cycle 2 day 1 predose, 0.5-4h, 6-10 h (Each cycle is 21 days)

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study

Units	Counts

Secondary

Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib

Sparse pharmacokinetic (PK) samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted CL/F for lenvatinib was then derived from the PK model. The data was collected and analyzed for lenvatinib plus pembrolizumab arm only.

The population pharmacokinetic analysis set includes all the participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm, and have measurable plasma levels of lenvatinib. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

liter per hour (L/h)

Cycle 1 Day 1: 0.5-10 hours post-dose; Cycle 1 Day 15: 0-12 hours post-dose; Cycle 2 Day 1: 0.5-10 hours post-dose (each cycle length=21 days)

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.

Units	Counts
Participants

Secondary

Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib

Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted AUC for lenvatinib was then derived from the PK model. The data was collected and analyzed for lenvatinib plus pembrolizumab arm only.

Posted

Mean

Standard Deviation

nanogram*hour per milliliter (ng*h/mL)

Cycle 1 Day 1: 0.5-10 hours post-dose; Cycle 1 Day 15: 0-12 hours post-dose; Cycle 2 Day 1: 0.5-10 hours post-dose (each cycle length=21 days)

ID	Title	Description
OG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0019 events9 affected388 at risk EG0020 events0 affected21 at risk EG0030 events0 affected6 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG00117 events16 affected388 at risk EG0020 events0 affected21 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0018 events8 affected388 at risk EG0020 events0 affected21 at risk EG003
Neutrophilia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Myocarditis	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Right ventricular dysfunction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0013 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Toxic cardiomyopathy	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Adrenocorticotropic hormone deficiency	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Iridocyclitis	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected406 at risk EG0011 events1 affected388 at risk EG0021 events1 affected21 at risk EG003
Colonic fistula	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00010 events10 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Duodenal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0005 events4 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Immune-mediated pancreatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Intestinal fistula	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Lower gastrointestinal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Malignant gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Mechanical ileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Rectal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0014 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0009 events9 affected406 at risk EG0014 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0005 events4 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG00010 events8 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0004 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Anaphylactic shock	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Abdominal sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Appendicitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Cystitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Device related infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Encephalitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastroenteritis Escherichia coli	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastroenteritis norovirus	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Infected fistula	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Influenza	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Pelvic abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Peritonitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0006 events6 affected406 at risk EG0014 events4 affected388 at risk EG0020 events0 affected21 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Psoas abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Retroperitoneal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0006 events6 affected406 at risk EG0015 events5 affected388 at risk EG0020 events0 affected21 at risk EG003
Septic shock	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Sialoadenitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Skin infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00016 events14 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Urosepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Vaginal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Wound infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
ECG signs of myocardial ischaemia	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Ejection fraction decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Lipase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0009 events9 affected406 at risk EG0010 events0 affected388 at risk EG0021 events1 affected21 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0012 events2 affected388 at risk EG0021 events1 affected21 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Encephalitis autoimmune	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Migraine	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Optic neuritis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Seizure	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Syncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Tremor	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Device dislocation	Product Issues	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Delirium	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Renal injury	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Urogenital fistula	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected406 at risk EG0015 events5 affected388 at risk EG0020 events0 affected21 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0003 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Umbilical haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Aortic thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG00017 events17 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Jugular vein thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Pelvic venous thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Vasculitis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Fistula of small intestine	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Ischaemic enteritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0010 events0 affected388 at risk EG0021 events1 affected21 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Catheter site inflammation	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Condition aggravated	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Death	General disorders	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Device related thrombosis	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
General physical health deterioration	General disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0011 events1 affected388 at risk EG0021 events1 affected21 at risk EG003
Generalised oedema	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hyperpyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Malaise	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Mucosal inflammation	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Perforated ulcer	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG0008 events8 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Liver injury	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Anal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Biliary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hepatitis A	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Omphalitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Acute myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Middle cerebral artery stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0009 events9 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Autoimmune nephritis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Renal disorder	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Lung opacity	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Assisted suicide	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0010 events0 affected388 at risk EG0021 events1 affected21 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG000171 events115 affected406 at risk EG001240 events181 affected388 at risk EG0021 events1 affected21 at risk EG0033 events1 affected6 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00072 events28 affected406 at risk EG00189 events50 affected388 at risk EG0023 events1 affected21 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00061 events26 affected406 at risk EG00145 events30 affected388 at risk EG0025 events2 affected21 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG000106 events38 affected406 at risk EG001213 events125 affected388 at risk EG0023 events1 affected21 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00066 events46 affected406 at risk EG00131 events26 affected388 at risk EG0020 events0 affected21 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG00050 events46 affected406 at risk EG0014 events4 affected388 at risk EG0021 events1 affected21 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG000299 events238 affected406 at risk EG0013 events3 affected388 at risk EG0025 events4 affected21 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000141 events96 affected406 at risk EG00158 events52 affected388 at risk EG0020 events0 affected21 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00075 events57 affected406 at risk EG00134 events28 affected388 at risk EG0023 events3 affected21 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000142 events116 affected406 at risk EG001119 events95 affected388 at risk EG0020 events0 affected21 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000686 events223 affected406 at risk EG001107 events76 affected388 at risk EG0025 events4 affected21 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00051 events43 affected406 at risk EG00116 events12 affected388 at risk EG0020 events0 affected21 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00037 events31 affected406 at risk EG00120 events20 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00026 events23 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00036 events31 affected406 at risk EG0018 events8 affected388 at risk EG0020 events0 affected21 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00030 events28 affected406 at risk EG0019 events7 affected388 at risk EG0020 events0 affected21 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000352 events212 affected406 at risk EG001302 events179 affected388 at risk EG0022 events1 affected21 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00097 events79 affected406 at risk EG00158 events46 affected388 at risk EG0021 events1 affected21 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000337 events149 affected406 at risk EG001122 events80 affected388 at risk EG0023 events2 affected21 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00019 events17 affected406 at risk EG00129 events24 affected388 at risk EG0020 events0 affected21 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG000171 events106 affected406 at risk EG00149 events39 affected388 at risk EG0022 events2 affected21 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG000160 events95 affected406 at risk EG00128 events22 affected388 at risk EG0021 events1 affected21 at risk EG003
Amylase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00060 events37 affected406 at risk EG0017 events5 affected388 at risk EG0020 events0 affected21 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG000160 events89 affected406 at risk EG00117 events16 affected388 at risk EG0021 events1 affected21 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00081 events55 affected406 at risk EG00119 events15 affected388 at risk EG0022 events1 affected21 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00030 events25 affected406 at risk EG00110 events7 affected388 at risk EG0020 events0 affected21 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00068 events40 affected406 at risk EG0019 events7 affected388 at risk EG0020 events0 affected21 at risk EG003
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00070 events49 affected406 at risk EG00110 events10 affected388 at risk EG0024 events2 affected21 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00061 events54 affected406 at risk EG0012 events1 affected388 at risk EG0021 events1 affected21 at risk EG003
Lipase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00086 events54 affected406 at risk EG0019 events8 affected388 at risk EG0023 events3 affected21 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG00028 events17 affected406 at risk EG00132 events24 affected388 at risk EG0020 events0 affected21 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG00039 events23 affected406 at risk EG001220 events95 affected388 at risk EG0020 events0 affected21 at risk EG003
Platelet count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG00096 events52 affected406 at risk EG00128 events23 affected388 at risk EG0020 events0 affected21 at risk EG003
Weight decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG000169 events147 affected406 at risk EG00124 events23 affected388 at risk EG0021 events1 affected21 at risk EG003
White blood cell count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG00029 events21 affected406 at risk EG001147 events63 affected388 at risk EG0022 events2 affected21 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG000253 events184 affected406 at risk EG00199 events83 affected388 at risk EG0025 events4 affected21 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00029 events22 affected406 at risk EG0017 events7 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00039 events27 affected406 at risk EG00111 events7 affected388 at risk EG0020 events0 affected21 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00080 events42 affected406 at risk EG00124 events19 affected388 at risk EG0022 events1 affected21 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG000102 events57 affected406 at risk EG00114 events12 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00056 events40 affected406 at risk EG00120 events18 affected388 at risk EG0025 events2 affected21 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG000148 events80 affected406 at risk EG00130 events27 affected388 at risk EG0023 events2 affected21 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00049 events38 affected406 at risk EG00116 events16 affected388 at risk EG0021 events1 affected21 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG000209 events137 affected406 at risk EG00133 events31 affected388 at risk EG0023 events2 affected21 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00076 events60 affected406 at risk EG00137 events30 affected388 at risk EG0025 events5 affected21 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00098 events72 affected406 at risk EG00125 events20 affected388 at risk EG0020 events0 affected21 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00073 events55 affected406 at risk EG00126 events22 affected388 at risk EG0021 events1 affected21 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00054 events46 affected406 at risk EG00129 events22 affected388 at risk EG0023 events2 affected21 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00046 events42 affected406 at risk EG00136 events29 affected388 at risk EG0020 events0 affected21 at risk EG003
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG000154 events107 affected406 at risk EG00136 events35 affected388 at risk EG0020 events0 affected21 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00026 events19 affected406 at risk EG00124 events23 affected388 at risk EG0020 events0 affected21 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG00038 events35 affected406 at risk EG00121 events20 affected388 at risk EG0020 events0 affected21 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG00028 events25 affected406 at risk EG00113 events11 affected388 at risk EG0020 events0 affected21 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG000275 events128 affected406 at risk EG00115 events13 affected388 at risk EG00210 events4 affected21 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00078 events63 affected406 at risk EG00155 events51 affected388 at risk EG0022 events2 affected21 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG000114 events95 affected406 at risk EG0014 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00055 events50 affected406 at risk EG00145 events43 affected388 at risk EG0023 events3 affected21 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00039 events34 affected406 at risk EG00113 events11 affected388 at risk EG0020 events0 affected21 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00031 events25 affected406 at risk EG00111 events9 affected388 at risk EG0021 events1 affected21 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00026 events25 affected406 at risk EG001120 events120 affected388 at risk EG0020 events0 affected21 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00037 events32 affected406 at risk EG00111 events11 affected388 at risk EG0020 events0 affected21 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00098 events86 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00059 events46 affected406 at risk EG00112 events12 affected388 at risk EG0022 events2 affected21 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00091 events66 affected406 at risk EG00113 events13 affected388 at risk EG0022 events2 affected21 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG000435 events255 affected406 at risk EG00128 events20 affected388 at risk EG0022 events1 affected21 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Diplopia	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Eye pruritus	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00010 events9 affected406 at risk EG0015 events5 affected388 at risk EG0021 events1 affected21 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0006 events4 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00025 events21 affected406 at risk EG0013 events3 affected388 at risk EG0020 events0 affected21 at risk EG003
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG000129 events99 affected406 at risk EG001124 events93 affected388 at risk EG0023 events2 affected21 at risk EG003
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG00016 events14 affected406 at risk EG0018 events7 affected388 at risk EG0021 events1 affected21 at risk EG003
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG000176 events138 affected406 at risk EG001146 events107 affected388 at risk EG0020 events0 affected21 at risk EG003
Malaise	General disorders	MedDRA 27.1	Systematic Assessment	EG00035 events25 affected406 at risk EG00129 events19 affected388 at risk EG0020 events0 affected21 at risk EG003
Mucosal inflammation	General disorders	MedDRA 27.1	Systematic Assessment	EG00073 events54 affected406 at risk EG00147 events38 affected388 at risk EG0020 events0 affected21 at risk EG003
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG00076 events57 affected406 at risk EG00140 events36 affected388 at risk EG0023 events3 affected21 at risk EG003
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG00099 events62 affected406 at risk EG00129 events26 affected388 at risk EG0022 events2 affected21 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00011 events11 affected406 at risk EG0010 events0 affected388 at risk EG0022 events2 affected21 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected406 at risk EG0015 events5 affected388 at risk EG0020 events0 affected21 at risk EG003
Cystitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00029 events24 affected406 at risk EG0018 events8 affected388 at risk EG0020 events0 affected21 at risk EG003
Fungal foot infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Influenza	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0008 events8 affected406 at risk EG0019 events8 affected388 at risk EG0020 events0 affected21 at risk EG003
Oral herpes	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0006 events4 affected406 at risk EG0017 events5 affected388 at risk EG0020 events0 affected21 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0015 events4 affected388 at risk EG0020 events0 affected21 at risk EG003
Tinea infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00027 events25 affected406 at risk EG00120 events17 affected388 at risk EG0022 events2 affected21 at risk EG003
Blood calcium decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Blood chloride decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00028 events23 affected406 at risk EG0012 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00030 events22 affected406 at risk EG00113 events12 affected388 at risk EG0021 events1 affected21 at risk EG003
Blood magnesium decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG00018 events8 affected406 at risk EG0017 events6 affected388 at risk EG0020 events0 affected21 at risk EG003
Blood phosphorus decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Blood sodium decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0009 events5 affected406 at risk EG0014 events4 affected388 at risk EG0020 events0 affected21 at risk EG003
Blood urea increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00011 events6 affected406 at risk EG0016 events4 affected388 at risk EG0020 events0 affected21 at risk EG003
International normalised ratio increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
White blood cell count increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0013 events2 affected388 at risk EG0020 events0 affected21 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00024 events21 affected406 at risk EG0013 events3 affected388 at risk EG0021 events1 affected21 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00026 events20 affected406 at risk EG0014 events4 affected388 at risk EG0023 events3 affected21 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00072 events60 affected406 at risk EG00135 events26 affected388 at risk EG0024 events2 affected21 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00029 events20 affected406 at risk EG00110 events7 affected388 at risk EG0022 events2 affected21 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00013 events11 affected406 at risk EG00110 events10 affected388 at risk EG0020 events0 affected21 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00023 events17 affected406 at risk EG0019 events8 affected388 at risk EG0020 events0 affected21 at risk EG003
Taste disorder	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0008 events7 affected406 at risk EG0016 events5 affected388 at risk EG0020 events0 affected21 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG00014 events14 affected406 at risk EG00111 events10 affected388 at risk EG0020 events0 affected21 at risk EG003
Initial insomnia	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Leukocyturia	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0009 events4 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG00026 events21 affected406 at risk EG00114 events12 affected388 at risk EG0020 events0 affected21 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected406 at risk EG0014 events4 affected388 at risk EG0020 events0 affected21 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected406 at risk EG0014 events4 affected388 at risk EG0021 events1 affected21 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0008 events7 affected406 at risk EG0014 events4 affected388 at risk EG0020 events0 affected21 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00010 events9 affected406 at risk EG0011 events1 affected388 at risk EG0020 events0 affected21 at risk EG003
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected406 at risk EG0010 events0 affected388 at risk EG0020 events0 affected21 at risk EG003
Hot flush	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0009 events8 affected406 at risk EG0018 events7 affected388 at risk EG0020 events0 affected21 at risk EG003

ID	Term
D016889	Endometrial 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
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
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates

ID	Title	Description
BG000	Lenvatinib 20 mg + Pembrolizumab 200 mg	Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
BG001	Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	First Course: Lenvatinib + Pembrolizumab	Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study	317	406	237	406	404	406
EG001	First Course: TPC Doxorubicin or Paclitaxel	Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.	362	388	121	388	379	388
EG002	Second Course: Lenvatinib + Pembrolizumab	Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) and lenvatinib (~2years) or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated a second course of pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto ~1 year)	8	21	4	21	20	21
EG003	TPC Crossover	Eligible participants who completed the first course of either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle and eligible participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated treatment with pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto ~1 year)	1	6	1	6	6	6

ID	Term
C582435	pembrolizumab
C531958	lenvatinib
D017239	Paclitaxel
D004317	Doxorubicin