Study of Pembrolizumab With Maintenance Olaparib or Maint... | NCT03976323

NCT03976323

Secondary IDs

ID	Type	Description
MK-7339-006	Other Identifier	MSD
KEYLYNK-006	Other Identifier	MSD
194895	Registry Identifier	JAPIC-CTI
2023-509774-40-00	Registry Identifier	EU CT
U1111-1300-7107	Registry Identifier	UTN
2018-004720-11	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib	Experimental	For the Induction Phase, participants receive 4 cycles (up to ~12 weeks [cycle = 3 weeks]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of each cycle (Cycles 1 through 4). If the participant has a complete/partial response or stable disease to induction therapy, the participant can enter the Maintenance Phase and receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. The participant can continue to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants can receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]).	Biological: Pembrolizumab Drug: Pemetrexed Drug: Carboplatin Drug: Cisplatin Drug: Olaparib
Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed	Active Comparator	For the Induction Phase, participants receive 4 cycles (up to ~12 weeks [cycle = 3 weeks]): pembrolizumab 200 mg IV on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin AUC 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of each cycle (Cycles 1 through 4). If the participant has a complete/partial response or stable disease to induction therapy, the participant can enter the Maintenance Phase and receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m^2 IV on Day 1 of each 3-week cycle. The participant can continue to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants can receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	IV infusion	Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS was analyzed by the non-parametric Kaplan-Meier (K-M) method. The protocol specified final analysis of PFS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Up to ~31 months
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause. OS was analyzed by the non-parametric K-M method. Participants without documented death at the time of analyses were censored at the date of last known to be alive. The protocol specified final analysis of OS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Up to ~51 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experience One or More Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported. The protocol specified final analysis will be presented for the first pembrolizumab course.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
Have stage IV nonsquamous NSCLC.
Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
Have measurable disease based on RECIST 1.1.
Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.

Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can start the induction phase. Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
Have a life expectancy of at least 3 months.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.
Have not received prior systemic treatment for their advanced/metastatic NSCLC.
Have adequate organ function.
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
Male participants must refrain from donating sperm, and female participants must refrain from donating eggs to others or freeze/store for her own use during the treatment period and for 180 days afterwards.

Exclusion Criteria:

Has predominantly squamous cell histology NSCLC.
Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
Has completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Oncology Bruno Cancer Center ( Site 0001)		Birmingham	Alabama	35205	United States
Northwest Alabama Cancer Center, PC ( Site 0002)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39521434	Result	Gray JE, Schenker M, Sendur MAN, Leonova V, Kowalski D, Kato T, Orlova R, Yang JC, Langleben A, Pilz A, Ungureanu A, Mak MP, De Angelis F, Aggarwal H, Zimmer Z, Zhao B, Shamoun M, Kim TM. The Phase 3 KEYLYNK-006 Study of Pembrolizumab Plus Olaparib Versus Pembrolizumab Plus Pemetrexed as Maintenance Therapy for Metastatic Nonsquamous NSCLC. J Thorac Oncol. 2025 Feb;20(2):219-232. doi: 10.1016/j.jtho.2024.10.026. Epub 2024 Nov 7.

Label	URL
Merck Clinical Trials Information	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase)	Participants received 4 cycles (up to ~12 weeks [cycle = 3 weeks]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of each cycle (Cycles 1 through 4).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 17, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase): All participants allocated to the pembrolizumab + Pemetrexed + Platinum Therapy arm in the Induction phase but not randomized into the maintenance phase; Pembrolizumab + Olaparib (Maintenance Phase): All participants randomized to the Pembrolizumab + Olaparib arm post Induction Phase; Pembrolizumab + Pemetrexed (Maintenance Phase): All participants randomized to the Pembrolizumab + Pemetrexed arm post Induction Phase.

Arm/Group Information

ID	Title	Description
BG000	Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase)	Participants received 4 cycles (up to ~12 weeks [cycle = 3 weeks]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of each cycle (Cycles 1 through 4).
BG001	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).
BG002	Pembrolizumab + Pemetrexed (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title	Denominators	Categories
	ParticipantsBG000331 ParticipantsBG001337 ParticipantsBG002335 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000331 ParticipantsBG001337 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000331 ParticipantsBG001337 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000331 ParticipantsBG001337 ParticipantsBG002

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline of Maintenance Phase

Participants were assessed for ECOG PS; Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature; Grade 2: Ambulatory & capable of all selfcare but unable to carry out any work activities, up & about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare, totally confined to bed or chair; Grade 5: Dead.

All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG001

Response at Baseline of Maintenance Phase

Response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) consisted of Complete Response (CR)/Partial Response (PR) or Stable Disease (SD). CR: Disappearance of all target lesions; PR: ≥30% decrease in the sum of diameters (SOD) of target lesions; SD: Neither sufficient shrinkage for PR nor sufficient increase for progressive disease (PD: ≥20% increase in the SOD of target lesions. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of ≥5 mm; appearance ≥1 new lesions is also PD).

All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG001

Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline of Maintenance Phase

Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a tumor proportion score (TPS) ≥50% were classified as PD-L1 strongly positive and participants with a TPS <50% were classified as not strongly positive.

All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG001

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)

PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS was analyzed by the non-parametric Kaplan-Meier (K-M) method. The protocol specified final analysis of PFS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

All randomized participants in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

Posted

Median

95% Confidence Interval

Months

Up to ~31 months

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).
OG001	Pembrolizumab + Pemetrexed (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Units	Counts
Participants	OG000337 OG001335

Title

Denominators

Categories

Title	Measurements
	OG0007.1(5.6 to 8.7) OG0018.3(6.9 to 11.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.8721	One-sided p-value based on log-rank test stratified by Eastern Cooperative Oncology Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.	Hazard Ratio (HR)	1.12			2-Sided	95	0.92	1.36			Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.		Superiority

Primary

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. OS was analyzed by the non-parametric K-M method. Participants without documented death at the time of analyses were censored at the date of last known to be alive. The protocol specified final analysis of OS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

All randomized participants in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

Posted

Median

95% Confidence Interval

Months

Up to ~51 months

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Secondary

Number of Participants Who Experience One or More Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported. The protocol specified final analysis will be presented for the first pembrolizumab course.

Not Posted

Dec 2026

Up to ~5 years

Participants

Secondary

Number of Participants Who Discontinue Study Treatment Due to an AE

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. The protocol specified final analysis will be presented for the first pembrolizumab course.

Not Posted

Dec 2026

Up to ~5 years

Participants

Secondary

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score

EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in GHS and QoL combined score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment and had at least 1 patient reported outcome (PRO) assessment available. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

Posted

Least Squares Mean

95% Confidence Interval

Scores on a scale

Baseline and Week 24

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Secondary

Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score

EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome was not done in the Induction Phase.

All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had data available for this EORTC QLQ-C30 outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase.

Posted

Median

95% Confidence Interval

Months

Up to ~24 months

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Secondary

Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score

EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding cough (Item 1): "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment and had at least 1 PRO assessment available. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

Posted

Least Squares Mean

95% Confidence Interval

Scores on a scale

Baseline and Week 24

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Secondary

TTD in EORTC QLQ-LC13 Cough (Item 1) Scale Score

EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding cough (Item 1): "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 1). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had data available for this EORTC QLQ-LC13 outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase.

Posted

Median

95% Confidence Interval

Months

Up to ~24 months

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Secondary

Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score

EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding chest pain (Item 10): "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

Posted

Least Squares Mean

95% Confidence Interval

Scores on a scale

Baseline and Week 24

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Secondary

TTD in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score

EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding chest pain (Item 10): "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in chest pain (Item 10). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had EORTC QLQ-LC13 data available for this outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase.

Posted

Median

95% Confidence Interval

Months

Up to ~24 months

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Secondary

Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question regarding dyspnea (Item 8): "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

Posted

Least Squares Mean

95% Confidence Interval

Scores on a scale

Baseline and Week 24

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Secondary

TTD in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question regarding dyspnea (Item 8): "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in dyspnea (Item 8). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

Posted

Median

95% Confidence Interval

Months

Up to ~24 months

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Secondary

Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 is computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score is presented. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

Posted

Least Squares Mean

95% Confidence Interval

Scores on a scale

Baseline and Week 24

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Secondary

TTD in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 is computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 1 to 5). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.

Posted

Median

95% Confidence Interval

Months

Up to ~24 months

ID	Title	Description
OG000	Pembrolizumab + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]). Qualified participants who completed up to ~35 cycles of pembrolizumab (up to ~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase)	Participants received 4 cycles (up to ~12 weeks [cycle = 3 weeks]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of each cycle (Cycles 1 through 4).	116	1,003	235	1,003	872	1,003
EG001	Pembrolizumab (First Course) + Olaparib (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]).	233	337	118	337	298	337
EG002	Pembrolizumab (First Course) + Pemetrexed (Maintenance Phase)	Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]).	233	335	125	332	289	332
EG003	Pembrolizumab (Second Course) + Olaparib (Maintenance Phase)	In the Maintenance Phase, qualified participants who received pembrolizumab (200 mg IV on Day 1 of each 3-week cycle) plus olaparib (300 mg orally twice daily until progressive disease or toxicity) and who completed up to ~35 cycles of pembrolizumab (up to ~2 years [cycle =3 weeks]) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).	0	7	0	7	2	7
EG004	Pembrolizumab (Second Course) + Pemetrexed (Maintenance Phase)	In the Maintenance Phase, qualified participants who received pembrolizumab (200 mg IV on Day 1 of each 3-week cycle) plus pemetrexed (500 mg/m^2 IV on Day 1 of each 3-week cycle until progressive disease or toxicity) and who completed up to ~35 cycles of pembrolizumab (up to ~2 years [cycle =3 weeks]) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to ~17 cycles (up to ~1 additional year).	2	13	1	13	9	13

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG00025 events24 affected1,003 at risk EG0019 events9 affected337 at risk EG0028 events8 affected332 at risk EG0030 events0 affected7 at risk EG0040 events0 affected13 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG00011 events11 affected1,003 at risk EG0012 events2 affected337 at risk EG0022 events2 affected332 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0008 events7 affected1,003 at risk EG0011 events1 affected337 at risk EG0022 events2 affected332 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG00014 events11 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG00022 events18 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0014 events4 affected337 at risk EG0022 events2 affected332 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0021 events1 affected332 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected1,003 at risk EG0011 events1 affected337 at risk EG0022 events2 affected332 at risk EG003
Myocarditis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected1,003 at risk EG0011 events1 affected337 at risk EG0022 events2 affected332 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0012 events2 affected337 at risk EG0022 events2 affected332 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Cataract	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0012 events2 affected337 at risk EG0022 events2 affected332 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected1,003 at risk EG0012 events2 affected337 at risk EG0021 events1 affected332 at risk EG003
Duodenal perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Gastrointestinal wall thickening	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Jejunal perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Noninfective sialoadenitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Proctitis ulcerative	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0021 events1 affected332 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected1,003 at risk EG0012 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Death	General disorders	MedDRA 24.1	Systematic Assessment	EG0008 events8 affected1,003 at risk EG0013 events3 affected337 at risk EG0025 events5 affected332 at risk EG003
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Gait disturbance	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
General physical health deterioration	General disorders	MedDRA 24.1	Systematic Assessment	EG0008 events8 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Hyperthermia	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Malaise	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events1 affected332 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0009 events9 affected1,003 at risk EG0012 events2 affected337 at risk EG0021 events1 affected332 at risk EG003
Serositis	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Sudden death	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0021 events1 affected332 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0013 events3 affected337 at risk EG0020 events0 affected332 at risk EG003
Hepatitis toxic	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Immune-mediated cholangitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0002 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0012 events2 affected337 at risk EG0020 events0 affected332 at risk EG003
Anal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Appendicitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0012 events2 affected337 at risk EG0020 events0 affected332 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Bronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0012 events2 affected337 at risk EG0020 events0 affected332 at risk EG003
Bronchopulmonary aspergillosis allergic	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0016 events6 affected337 at risk EG0022 events2 affected332 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0009 events9 affected1,003 at risk EG0016 events6 affected337 at risk EG00218 events17 affected332 at risk EG003
Cellulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Dengue fever	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Device related infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Empyema	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Encephalitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Erysipelas	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0024 events4 affected332 at risk EG003
Gangrene	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Giardiasis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Infectious pleural effusion	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Influenza	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Laryngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Pleural infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00023 events23 affected1,003 at risk EG00116 events14 affected337 at risk EG00211 events11 affected332 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0023 events3 affected332 at risk EG003
Pneumonia pseudomonal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Prostate infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Rectal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00011 events11 affected1,003 at risk EG0012 events2 affected337 at risk EG0021 events1 affected332 at risk EG003
Septic shock	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Serratia infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Severe acute respiratory syndrome	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Suspected COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Testicular abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Tuberculosis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0021 events1 affected332 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Urethritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0006 events5 affected1,003 at risk EG0012 events2 affected337 at risk EG0020 events0 affected332 at risk EG003
Urosepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Viral infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Wound infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0021 events1 affected332 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Incision site pain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0021 events1 affected332 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Blood creatinine increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events1 affected1,003 at risk EG0011 events1 affected337 at risk EG0021 events1 affected332 at risk EG003
Creatinine renal clearance decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events1 affected332 at risk EG003
Influenza A virus test positive	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Transaminases increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Weight decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected1,003 at risk EG0012 events2 affected337 at risk EG0021 events1 affected332 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Food intolerance	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events1 affected332 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0021 events1 affected332 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected1,003 at risk EG0012 events2 affected337 at risk EG0021 events1 affected332 at risk EG003
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Brain injury	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Brain oedema	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Cerebellar ataxia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Cerebral haematoma	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected1,003 at risk EG0012 events2 affected337 at risk EG0021 events1 affected332 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Dural arteriovenous fistula	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Immune-mediated encephalitis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0011 events1 affected337 at risk EG0021 events1 affected332 at risk EG003
Lethargy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Leukoencephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Speech disorder	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Superior sagittal sinus thrombosis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Syncope	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected1,003 at risk EG0011 events1 affected337 at risk EG0023 events3 affected332 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Vascular dementia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Device dislocation	Product Issues	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Delirium	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Panic attack	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected1,003 at risk EG0011 events1 affected337 at risk EG0023 events3 affected332 at risk EG003
Diabetic nephropathy	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Nephropathy	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0011 events1 affected337 at risk EG0021 events1 affected332 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Aphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0015 events3 affected337 at risk EG0026 events5 affected332 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0007 events7 affected1,003 at risk EG0013 events3 affected337 at risk EG0022 events2 affected332 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0012 events2 affected337 at risk EG0021 events1 affected332 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00012 events11 affected1,003 at risk EG0011 events1 affected337 at risk EG0025 events5 affected332 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0007 events7 affected1,003 at risk EG0017 events7 affected337 at risk EG00210 events10 affected332 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0012 events2 affected337 at risk EG0022 events2 affected332 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00010 events10 affected1,003 at risk EG0017 events7 affected337 at risk EG0020 events0 affected332 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0012 events2 affected337 at risk EG0020 events0 affected332 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Euthanasia	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Angiodysplasia	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Aortic aneurysm rupture	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Aortitis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Arterial thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0011 events1 affected337 at risk EG0020 events0 affected332 at risk EG003
Embolism	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Subclavian artery embolism	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Superficial vein thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Vascular occlusion	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG000432 events385 affected1,003 at risk EG001176 events122 affected337 at risk EG002199 events125 affected332 at risk EG0031 events1 affected7 at risk EG0042 events2 affected13 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG000208 events141 affected1,003 at risk EG00183 events48 affected337 at risk EG00241 events19 affected332 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG00022 events17 affected1,003 at risk EG00131 events19 affected337 at risk EG00224 events14 affected332 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG000371 events235 affected1,003 at risk EG001105 events57 affected337 at risk EG00260 events32 affected332 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG000156 events114 affected1,003 at risk EG00193 events57 affected337 at risk EG00260 events35 affected332 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG00027 events27 affected1,003 at risk EG00141 events35 affected337 at risk EG00220 events19 affected332 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0011 events1 affected337 at risk EG0027 events6 affected332 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG000199 events169 affected1,003 at risk EG00124 events21 affected337 at risk EG00252 events39 affected332 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG000121 events101 affected1,003 at risk EG00163 events39 affected337 at risk EG00257 events35 affected332 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG000485 events310 affected1,003 at risk EG001106 events81 affected337 at risk EG002167 events63 affected332 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG000110 events83 affected1,003 at risk EG00142 events28 affected337 at risk EG00235 events24 affected332 at risk EG003
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG000141 events107 affected1,003 at risk EG00142 events31 affected337 at risk EG00260 events38 affected332 at risk EG003
Chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG00028 events28 affected1,003 at risk EG00122 events22 affected337 at risk EG00224 events20 affected332 at risk EG003
Early satiety	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG000161 events140 affected1,003 at risk EG00172 events58 affected337 at risk EG00273 events54 affected332 at risk EG003
Influenza like illness	General disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected1,003 at risk EG0013 events2 affected337 at risk EG0025 events5 affected332 at risk EG003
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG00023 events23 affected1,003 at risk EG00111 events11 affected337 at risk EG00266 events49 affected332 at risk EG003
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG00062 events54 affected1,003 at risk EG00143 events36 affected337 at risk EG00248 events27 affected332 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0005 events4 affected1,003 at risk EG0011 events1 affected337 at risk EG0024 events4 affected332 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG00134 events29 affected337 at risk EG00228 events28 affected332 at risk EG003
Rhinitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected1,003 at risk EG0015 events2 affected337 at risk EG0022 events2 affected332 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG000122 events110 affected1,003 at risk EG00142 events31 affected337 at risk EG00297 events52 affected332 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00091 events81 affected1,003 at risk EG00138 events28 affected337 at risk EG00286 events55 affected332 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00035 events33 affected1,003 at risk EG00112 events10 affected337 at risk EG00219 events14 affected332 at risk EG003
Blood creatinine increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00037 events35 affected1,003 at risk EG00163 events46 affected337 at risk EG00267 events40 affected332 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00017 events17 affected1,003 at risk EG0016 events4 affected337 at risk EG00214 events10 affected332 at risk EG003
Weight decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG00030 events29 affected1,003 at risk EG00139 events31 affected337 at risk EG00220 events18 affected332 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG000190 events155 affected1,003 at risk EG00177 events52 affected337 at risk EG00279 events52 affected332 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00032 events32 affected1,003 at risk EG00117 events12 affected337 at risk EG00233 events25 affected332 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00028 events24 affected1,003 at risk EG00129 events15 affected337 at risk EG00230 events14 affected332 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00013 events12 affected1,003 at risk EG0019 events9 affected337 at risk EG00215 events12 affected332 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00033 events30 affected1,003 at risk EG00116 events11 affected337 at risk EG00224 events19 affected332 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00024 events21 affected1,003 at risk EG00114 events9 affected337 at risk EG00212 events10 affected332 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00034 events34 affected1,003 at risk EG00160 events47 affected337 at risk EG00243 events35 affected332 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00030 events28 affected1,003 at risk EG00132 events31 affected337 at risk EG00232 events26 affected332 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected1,003 at risk EG0010 events0 affected337 at risk EG0022 events2 affected332 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00015 events14 affected1,003 at risk EG00118 events15 affected337 at risk EG00222 events18 affected332 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00020 events18 affected1,003 at risk EG00122 events19 affected337 at risk EG00223 events20 affected332 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00036 events34 affected1,003 at risk EG00135 events31 affected337 at risk EG00230 events27 affected332 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00033 events26 affected1,003 at risk EG00120 events18 affected337 at risk EG00212 events8 affected332 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00041 events36 affected1,003 at risk EG00136 events29 affected337 at risk EG00234 events29 affected332 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0009 events9 affected1,003 at risk EG0018 events6 affected337 at risk EG00213 events12 affected332 at risk EG003
Affect lability	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected1,003 at risk EG0010 events0 affected337 at risk EG0020 events0 affected332 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00036 events36 affected1,003 at risk EG00141 events33 affected337 at risk EG00248 events38 affected332 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00055 events54 affected1,003 at risk EG00127 events26 affected337 at risk EG00248 events42 affected332 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0009 events9 affected1,003 at risk EG00114 events12 affected337 at risk EG00215 events10 affected332 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG00054 events52 affected1,003 at risk EG00138 events32 affected337 at risk EG00239 events29 affected332 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG00076 events75 affected1,003 at risk EG00137 events31 affected337 at risk EG00243 events37 affected332 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected1,003 at risk EG0010 events0 affected337 at risk EG0021 events1 affected332 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG00026 events24 affected1,003 at risk EG00114 events11 affected337 at risk EG00218 events17 affected332 at risk EG003

ID	Term
D002277	Carcinoma
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
C582435	pembrolizumab
D000068437	Pemetrexed
D016190	Carboplatin
D002945	Cisplatin
C531550	olaparib

Ancestor Terms

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic
D056831	Coordination Complexes
D009930	Organic Chemicals
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ParticipantsBG0031003

ParticipantsBG002335

ParticipantsBG003672

ParticipantsBG002335

ParticipantsBG003672

ParticipantsBG002335

ParticipantsBG003672

EG0040 events0 affected13 at risk

EG0041 events1 affected13 at risk

EG0040 events0 affected13 at risk

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms