Study of Pembrolizumab (MK-3475) vs Placebo for Participa... | NCT02504372

ID	Type	Description
EORTC-1416-LCG	Other Identifier	EORTC
163457	Registry Identifier	JAPIC-CTI
MK-3475-091	Other Identifier	MSD
KEYNOTE-091	Other Identifier	MSD
2023-509137-39-00	Registry Identifier	EU CT
U1111-1309-6051	Registry Identifier	UTN
2015-000575-27	EudraCT Number

Name	Class
ETOP	UNKNOWN
European Organisation for Research and Treatment of Cancer - EORTC	NETWORK

Label	Type	Description	Intervention Names
Pembrolizumab	Experimental	Participants receive pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year (expected maximum 18 doses).	Biological: Pembrolizumab
Placebo	Placebo Comparator	Participants receive placebo, IV, every 3 weeks, for one year (expected maximum 18 doses).	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	IV infusion	Pembrolizumab	MK-3475

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-Free Survival (DFS)	DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.	Up to approximately 84 months
DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%	DFS in PDL-1 strong positive participants with TPS ≥50% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.	Up to approximately 84 months

Secondary Outcomes

Measure	Description	Time Frame
DFS in PDL-1 Strong Positive Participants With TPS ≥1%	DFS in PDL-1 strong positive participants with TPS ≥1% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

Other Outcomes

Measure	Description	Time Frame
DFS at 68 Months	DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.	Up to approximately 68 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathological diagnosis of NSCLC confirmed at surgery, any histology. Participants with two synchronous primary non-small cell lung cancers are excluded from the study
Union for International Cancer Control (UICC) v7 Stage IB with T ≥ 4 cm, II-IIIA NSCLC after complete surgical resection with resection margins proved microscopically free of disease (R0). Carcinoma in situ can be present at the bronchial margin
Available tumor sample obtained at surgical resection for programmed cell death ligand-1 (PD-L1) Immunohistochemistry (IHC) expression assessment
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Adequate organ function performed within 10 days of treatment initiation
Female participants of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first infusion of study medication). If the urine test cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the participant to be eligible
Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity starting with the first infusion of study treatment through 120 days after the last infusion of study treatment
Female participants who are breast feeding must discontinue nursing prior to the first infusion of study medication and until 120 days after the last infusion study treatment
Male participants must agree to use an adequate method of contraception starting with the first infusion of study treatment through 120 days after the last infusion of study treatment
Absence of severe comorbidities that in the opinion of the Investigator might hamper the participation to the study and/or the treatment administration
No prior or planned neo-adjuvant or adjuvant radiotherapy and/or neo-adjuvant chemotherapy for the current malignancy is allowed

Exclusion Criteria:

Evidence of disease at clinical examination and/or baseline radiological assessment as documented by contrast enhanced chest/upper abdomen CT scan, brain CT/MRI and clinical examination
More than 4 cycles of adjuvant therapy
Prior treatment with anti-programmed cell death (anti-PD)-1, anti-PD ligand-1/2, anti-CD137, or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) modulators or any other immune-modulating agents
Live vaccine within 30 days prior to the first infusion of study treatment
Current participation or treatment with an investigational agent or use of an investigational device within 4 weeks of the first infusion of study treatment
History of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive). No known active Hepatitis B or C
Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 3 days prior to the first infusion of study treatment
History of interstitial lung disease or (non-infectious) pneumonitis that required oral or IV steroids (other than COPD exacerbation) or current pneumonitis
Active autoimmune disease that has required systemic treatment in past 2 years
History of a hematologic or primary solid tumor malignancy, unless in remission for at least 5 years with the exception of pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanomatous skin cancer or carcinoma in situ of the cervix
Previous allogeneic tissue/solid organ transplant
Active infection requiring therapy
Surgery- or chemotherapy-related toxicity (non-hematological) not resolved to Grade 1 with the exception of alopecia, fatigue, neuropathy and lack of appetite /nausea
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last infusion of study treatment
Participant will not be eligible if the participant is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective site Review Board approval is given allowing exception to this criterion for a specific participant

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

PubMed Identifier	Type	Citation	Retractions
36108662	Derived	O'Brien M, Paz-Ares L, Marreaud S, Dafni U, Oselin K, Havel L, Esteban E, Isla D, Martinez-Marti A, Faehling M, Tsuboi M, Lee JS, Nakagawa K, Yang J, Samkari A, Keller SM, Mauer M, Jha N, Stahel R, Besse B, Peters S; EORTC-1416-LCG/ETOP 8-15 - PEARLS/KEYNOTE-091 Investigators. Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB-IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial. Lancet Oncol. 2022 Oct;23(10):1274-1286. doi: 10.1016/S1470-2045(22)00518-6. Epub 2022 Sep 12.

Label	URL
Merck Clinical Trials Information	View source

ID	Title	Description
FG000	Pembrolizumab	Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
FG001	Placebo	Participants received placebo, IV, every 3 weeks, for one year.

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	Sep 23, 2022

ID	Title	Description
BG000	Pembrolizumab	Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
BG001	Placebo	Participants received placebo, IV, every 3 weeks, for one year.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000590 BG001587 BG0021177

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG00053.8(46.2 to 67.0) OG00143.0(35.0 to 51.6)

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						Hazard Ratio (HR)	0.81			2-Sided	95	0.68	0.96			HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.		Other

Primary

DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%

DFS in PDL-1 strong positive participants with TPS ≥50% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

All randomized PDL-1 strong positive participants with TPS ≥50%. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

Posted

Median

95% Confidence Interval

Months

Up to approximately 84 months

ID	Title	Description
OG000	Pembrolizumab	Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
OG001	Placebo	Participants received placebo, IV, every 3 weeks, for one year.

Units	Counts
Participants

Secondary

DFS in PDL-1 Strong Positive Participants With TPS ≥1%

DFS in PDL-1 strong positive participants with TPS ≥1% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

All randomized PDL-1 strong positive participants with TPS ≥1%. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

Posted

Median

95% Confidence Interval

Months

Up to approximately 84 months

ID	Title	Description
OG000	Pembrolizumab	Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
OG001	Placebo	Participants received placebo, IV, every 3 weeks, for one year.

Units	Counts
Participants

Secondary

Overall Survival (OS)

OS was defined as the time from randomization to the date of death.

Not Posted

Feb 2028

Up to approximately 132 months

Participants

Secondary

OS in PDL-1 Strong Positive Participants With TPS ≥50%

OS in PDL-1 Strong Positive Participants with TPS ≥50% was defined as the time from randomization to the date of death.

Not Posted

Feb 2028

Up to approximately 132 months

Participants

Secondary

OS in PDL-1 Strong Positive Participants With TPS ≥1%

OS in PDL-1 Strong Positive Participants with TPS ≥1% was defined as the time from randomization to the date of death.

Not Posted

Feb 2028

Up to approximately 132 months

Participants

Secondary

Lung Cancer Specific Survival (LCSS)

LCSS was defined as the time from randomization to the date of death (due to lung cancer specifically).

Not Posted

Feb 2028

Up to approximately 132 months

Participants

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. The number of participants who experienced an AE were reported.

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

Posted

Count of Participants

Participants

Up to approximately 22 months

ID	Title	Description
OG000	Pembrolizumab	Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
OG001	Placebo	Participants received placebo, IV, every 3 weeks, for one year.

Units	Counts
Participants

Secondary

Number of Participants Who Discontinued Study Treatment Due to an AE

Posted

Count of Participants

Participants

Up to approximately 19 months

ID	Title	Description
OG000	Pembrolizumab	Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
OG001	Placebo	Participants received placebo, IV, every 3 weeks, for one year.

Units	Counts
Participants

Other Pre-specified

DFS at 68 Months

All randomized participants. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

Posted

Median

95% Confidence Interval

Months

Up to approximately 68 months

ID	Title	Description
OG000	Pembrolizumab	Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
OG001	Placebo	Participants received placebo, IV, every 3 weeks, for one year.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Angina pectoris	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0010 events0 affected581 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0011 events1 affected581 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Cardiac arrest	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Coronary artery disease	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Myocardial infarction	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected580 at risk EG0013 events3 affected581 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Myocarditis	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0007 events5 affected580 at risk EG0010 events0 affected581 at risk
Pericardial effusion	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0010 events0 affected581 at risk
Glucocorticoid deficiency	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected580 at risk EG0010 events0 affected581 at risk
Hypophysitis	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected580 at risk EG0010 events0 affected581 at risk
Hypothyroidism	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected580 at risk EG0010 events0 affected581 at risk
Cataract	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Colitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0005 events4 affected580 at risk EG0014 events2 affected581 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00011 events7 affected580 at risk EG0011 events1 affected581 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Melaena	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0011 events1 affected581 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0014 events2 affected581 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events1 affected581 at risk
Asthenia	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0011 events1 affected581 at risk
Cardiac death	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Death	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
General physical health deterioration	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0010 events0 affected581 at risk
Performance status decreased	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0013 events3 affected581 at risk
Sudden death	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0010 events0 affected581 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected580 at risk EG0011 events1 affected581 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected580 at risk EG0010 events0 affected581 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events1 affected581 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0004 events1 affected580 at risk EG0010 events0 affected581 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected580 at risk EG0010 events0 affected581 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected580 at risk EG0010 events0 affected581 at risk
Jaundice	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Anaphylactic shock	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Hypersensitivity	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Sarcoidosis	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Appendicitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0011 events1 affected581 at risk
Atypical pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Bronchitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0004 events3 affected580 at risk EG0011 events1 affected581 at risk
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0011 events1 affected581 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Diverticulitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events1 affected581 at risk
Erysipelas	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Gastroenteritis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0010 events0 affected581 at risk
Large intestine infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected580 at risk EG0012 events2 affected581 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Penile infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00015 events13 affected580 at risk EG00111 events9 affected581 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0012 events1 affected581 at risk
Post procedural pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events1 affected581 at risk
Pyelonephritis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events1 affected580 at risk EG0010 events0 affected581 at risk
Sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0004 events3 affected580 at risk EG0013 events3 affected581 at risk
Septic shock	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Skin infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected580 at risk EG0012 events2 affected581 at risk
Urosepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Vascular device infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events2 affected581 at risk
Viral infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0011 events1 affected581 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected580 at risk EG0010 events0 affected581 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0010 events0 affected581 at risk
Incision site discharge	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Poisoning	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events2 affected581 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0011 events1 affected581 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Blood creatinine increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Troponin T increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0013 events1 affected581 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0012 events1 affected581 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0010 events0 affected581 at risk
Back disorder	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0011 events1 affected581 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Sarcopenia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0011 events1 affected581 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events1 affected581 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events2 affected581 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events2 affected581 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0013 events1 affected581 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events1 affected581 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events1 affected581 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Tracheal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Ataxia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Brain stem stroke	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Cerebral infarction	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0011 events1 affected581 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Dizziness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Dysaesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Dysarthria	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Intensive care unit acquired weakness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Retrograde amnesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Superior sagittal sinus thrombosis	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Syncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Device dislocation	Product Issues	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Completed suicide	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Confusional state	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0013 events1 affected581 at risk
Neurosis	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0010 events0 affected581 at risk
Azotaemia	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Renal failure	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Urinary retention	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0008 events5 affected580 at risk EG0012 events1 affected581 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected580 at risk EG0014 events4 affected581 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0005 events3 affected580 at risk EG0010 events0 affected581 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00015 events12 affected580 at risk EG0014 events4 affected581 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected580 at risk EG0011 events1 affected581 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected580 at risk EG0010 events0 affected581 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Scar pain	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected580 at risk EG0010 events0 affected581 at risk
Aortic aneurysm	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0012 events1 affected581 at risk
Arterial thrombosis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk
Giant cell arteritis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Hypertensive crisis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected580 at risk EG0010 events0 affected581 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected580 at risk EG0011 events1 affected581 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hyperthyroidism	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG00065 events62 affected580 at risk EG00118 events17 affected581 at risk
Hypothyroidism	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG000148 events120 affected580 at risk EG00129 events27 affected581 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00038 events35 affected580 at risk EG00153 events41 affected581 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG000179 events104 affected580 at risk EG001160 events82 affected581 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00064 events52 affected580 at risk EG00148 events37 affected581 at risk
Asthenia	General disorders	MedDRA 25.1	Systematic Assessment	EG00066 events44 affected580 at risk EG00139 events32 affected581 at risk
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG000131 events96 affected580 at risk EG001118 events89 affected581 at risk
Influenza like illness	General disorders	MedDRA 25.1	Systematic Assessment	EG00039 events34 affected580 at risk EG00136 events32 affected581 at risk
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG00034 events31 affected580 at risk EG00148 events32 affected581 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00065 events50 affected580 at risk EG00144 events32 affected581 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00063 events52 affected580 at risk EG00168 events55 affected581 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG00075 events46 affected580 at risk EG00142 events34 affected581 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG00061 events41 affected580 at risk EG00140 events31 affected581 at risk
Blood creatinine increased	Investigations	MedDRA 25.1	Systematic Assessment	EG00060 events38 affected580 at risk EG00152 events32 affected581 at risk
Weight decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG00059 events39 affected580 at risk EG00136 events25 affected581 at risk
Weight increased	Investigations	MedDRA 25.1	Systematic Assessment	EG000260 events132 affected580 at risk EG001314 events168 affected581 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG00049 events41 affected580 at risk EG00128 events26 affected581 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG000152 events107 affected580 at risk EG00199 events72 affected581 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG00051 events45 affected580 at risk EG00157 events46 affected581 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG00047 events37 affected580 at risk EG00116 events15 affected581 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG00020 events18 affected580 at risk EG00138 events31 affected581 at risk
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG00067 events45 affected580 at risk EG00160 events46 affected581 at risk
Paraesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG00019 events18 affected580 at risk EG00139 events32 affected581 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG000101 events87 affected580 at risk EG001130 events98 affected581 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00087 events66 affected580 at risk EG00191 events72 affected581 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00052 events32 affected580 at risk EG00120 events15 affected581 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00046 events37 affected580 at risk EG00118 events15 affected581 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG00034 events31 affected580 at risk EG00125 events21 affected581 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG000167 events125 affected580 at risk EG001115 events74 affected581 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG00069 events49 affected580 at risk EG00137 events29 affected581 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG00062 events43 affected580 at risk EG00127 events20 affected581 at risk
Hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG000160 events67 affected580 at risk EG001184 events74 affected581 at risk

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pembrolizumab	Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	136	590	142	580	510	580
EG001	Placebo	Participants received placebo, IV, every 3 weeks, for one year.	154	587	90	581	458	581