A Trial of Pembrolizumab in Combination With Chemotherapy... | NCT03631784

ID	Type	Description	Link
MK-3475-799	Other Identifier	MSD Protocol Number
2018-000714-37	EudraCT Number

Label	Type	Description	Intervention Names
Cohort A	Experimental	Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.	Drug: Pembrolizumab 200 mg Drug: Paclitaxel 45 mg/m^2 Drug: Carboplatin AUC6 Radiation: Thoracic Radiation Therapy (TRT) Drug: Paclitaxel 200 mg/m^2 Drug: Carboplatin AUC2
Cohort B	Experimental	Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.	Drug: Pembrolizumab 200 mg Drug: Cisplatin 75 mg/m^2 Drug: Pemetrexed 500 mg/m^2 Radiation: Thoracic Radiation Therapy (TRT)

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab 200 mg	Drug	Pembrolizumab 200 mg intravenous (IV) infusion on Days 1 of each 3-week cycle for up to 17 cycles	Cohort A Cohort B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis	Pneumonitis included the MedDRA preferred terms for radiation pneumonitis are acute interstitial pneumonitis, autoimmune lung disease, interstitial lung disease, pneumonitis, idiopathic pneumonia syndrome, organizing pneumonia, and immune-mediated pneumonitis. As per common terminology criteria for Adverse Events, version 4.0, pneumonitis was graded as follows: Grade (Gr) 1- asymptomatic, clinical or diagnostic observations only; intervention not indicated; Gr 2- symptomatic, medical intervention indicated, limiting instrumental activities of daily living (ADL); Gr 3- severe symptoms; limiting self-care activities of daily living (ADL), oxygen indicated; Gr 4- life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation); Gr 5- death.	Up to approximately 3 years
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	ORR was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified RECIST 1.1 by blinded independent central review (BICR).	Up to approximately 3 years

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	PFS was defined as the time from the first dose of study treatment to the date of the first documentation of disease progression, as determined by BICR per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum, and/or unequivocal progression of existing non-target lesions, and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male/female participants, who are at least 18 years of age on the day of signing informed consent with previously untreated, unresectable, pathologically confirmed NSCLC and Stage IIIA, IIIB or IIIC NSCLC by American Joint Committee on Cancer Version 8.
No evidence of metastatic disease by whole body positron emission tomography/computed tomography (PET/ CT) scan, diagnostic quality CT scan, and brain imaging.
Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
Have provided tumor tissue sample (core, incisional, or excisional biopsy).
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Have adequate pulmonary function test (PFT)
Have adequate organ function
A male participant must agree to use contraception through the end of treatment and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and if participant is a woman of childbearing potential (WOCBP), agrees to follow the contraceptive guidance as provided in the protocol through the end of treatment.

Exclusion Criteria:

A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation
Has small cell lung cancer.
Has had documented weight loss >10% in the preceding 3 months.
Participants whose radiation treatment plans are likely to encompass a volume of whole lung receiving >20 Gy in total (V20) of more than 31% of lung volume.
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus or for breast cancer.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent (programmed cell death protein 1 [PD-1] and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 [PD-L2]) or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Has received a live vaccine within 30 days prior to the first dose of study drug.
Has had an allogenic tissue/solid organ transplant.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
Has severe hypersensitivity (Grade 3 or higher) to pembrolizumab and/or any of its excipients.
Has a known severe hypersensitivity (Grade 3 or higher) to any of the study chemotherapy agents and/or to any of their excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Has a known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study through the end of treatment.

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

Facility	Status	City	State	ZIP	Country	Contacts
St Joseph Heritage Healthcare ( Site 1403)		Santa Rosa	California	95403	United States
North Shore University Health System ( Site 1413)

PubMed Identifier	Type	Citation	Retractions
34086039	Result	Jabbour SK, Lee KH, Frost N, Breder V, Kowalski DM, Pollock T, Levchenko E, Reguart N, Martinez-Marti A, Houghton B, Paoli JB, Safina S, Park K, Komiya T, Sanford A, Boolell V, Liu H, Samkari A, Keller SM, Reck M. Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. JAMA Oncol. 2021 Jun 4;7(9):1-9. doi: 10.1001/jamaoncol.2021.2301. Online ahead of print.

Label	URL
Merck Clinical Trials Information	View source

ID	Title	Description
FG000	Pembrolizumab + cCRT + Paclitaxel + Carboplatin	Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

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	Dec 5, 2022

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

Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis

Pneumonitis included the MedDRA preferred terms for radiation pneumonitis are acute interstitial pneumonitis, autoimmune lung disease, interstitial lung disease, pneumonitis, idiopathic pneumonia syndrome, organizing pneumonia, and immune-mediated pneumonitis. As per common terminology criteria for Adverse Events, version 4.0, pneumonitis was graded as follows: Grade (Gr) 1- asymptomatic, clinical or diagnostic observations only; intervention not indicated; Gr 2- symptomatic, medical intervention indicated, limiting instrumental activities of daily living (ADL); Gr 3- severe symptoms; limiting self-care activities of daily living (ADL), oxygen indicated; Gr 4- life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation); Gr 5- death.

The analysis population consisted of all participants who received at least one dose of study drug.

Posted

Number

90% Confidence Interval

Percentage of Participants

Up to approximately 3 years

ID	Title	Description
OG000	Pembrolizumab + cCRT + Paclitaxel + Carboplatin	Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
OG001	Pembrolizumab + cCRT + Pemetrexed + Cisplatin	Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

Units	Counts
Participants	OG000112 OG001102

Title

Denominators

Categories

Title	Measurements
	OG0008.0(4.3 to 13.6) OG0016.9(3.3 to 12.5)

Primary

Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

ORR was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified RECIST 1.1 by blinded independent central review (BICR).

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

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 3 years

ID	Title	Description
OG000	Pembrolizumab + cCRT + Paclitaxel + Carboplatin	Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
OG001	Pembrolizumab + cCRT + Pemetrexed + Cisplatin	Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

Secondary

Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

PFS was defined as the time from the first dose of study treatment to the date of the first documentation of disease progression, as determined by BICR per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum, and/or unequivocal progression of existing non-target lesions, and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.

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

Posted

Median

95% Confidence Interval

Months

Up to approximately 5 1/2 years

ID	Title	Description
OG000	Pembrolizumab + cCRT + Paclitaxel + Carboplatin	Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
OG001

Secondary

Overall Survival (OS)

OS is defined as the time from enrollment to death due to any cause. OS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.

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

Posted

Median

95% Confidence Interval

Months

Up to approximately 5 1/2 years

ID	Title	Description
OG000	Pembrolizumab + cCRT + Paclitaxel + Carboplatin	Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
OG001	Pembrolizumab + cCRT + Pemetrexed + Cisplatin	Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed.

The analysis population consisted of all participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to approximately 1 1/2 years

ID	Title	Description
OG000	Pembrolizumab + cCRT + Paclitaxel + Carboplatin	Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
OG001	Pembrolizumab + cCRT + Pemetrexed + Cisplatin	Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

Secondary

Number of Participants Who Discontinued From Study Treatment Due to an AE

The analysis population consisted of all participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to approximately 1 year

ID	Title	Description
OG000	Pembrolizumab + cCRT + Paclitaxel + Carboplatin	Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
OG001	Pembrolizumab + cCRT + Pemetrexed + Cisplatin

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0013 events3 affected102 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected112 at risk EG0010 events0 affected102 at risk
Haematotoxicity	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0011 events1 affected102 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Myocarditis	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Pericardial effusion	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected112 at risk EG0010 events0 affected102 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Hypophysitis	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected112 at risk EG0010 events0 affected102 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Gastritis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected112 at risk EG0011 events1 affected102 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Oesophageal perforation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected112 at risk EG0010 events0 affected102 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0011 events1 affected102 at risk
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected112 at risk EG0012 events2 affected102 at risk
Death	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Device related thrombosis	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected112 at risk EG0010 events0 affected102 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0019 events7 affected102 at risk
Sudden death	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected112 at risk EG0010 events0 affected102 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Anal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Biliary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0011 events1 affected102 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0012 events2 affected102 at risk
Catheter site infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0011 events1 affected102 at risk
Cystitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Device related infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Encephalitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected112 at risk EG0010 events0 affected102 at risk
Orchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0012 events2 affected102 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00015 events14 affected112 at risk EG00111 events9 affected102 at risk
Pneumonia necrotising	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Pyelonephritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected112 at risk EG0010 events0 affected102 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected112 at risk EG0010 events0 affected102 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected112 at risk EG0011 events1 affected102 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Neutrophil count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Platelet count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0011 events1 affected102 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0012 events2 affected102 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Hypertrophic osteoarthropathy	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0012 events1 affected102 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0011 events1 affected102 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0012 events2 affected102 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Prerenal failure	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0011 events1 affected102 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected112 at risk EG0015 events5 affected102 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0011 events1 affected102 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0014 events4 affected102 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0012 events2 affected102 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected112 at risk EG0010 events0 affected102 at risk
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk
Embolism	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected102 at risk
Thrombophlebitis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected102 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00053 events44 affected112 at risk EG00140 events33 affected102 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00029 events15 affected112 at risk EG00111 events8 affected102 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00013 events11 affected112 at risk EG00116 events12 affected102 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00050 events32 affected112 at risk EG00129 events23 affected102 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00022 events17 affected112 at risk EG0013 events3 affected102 at risk
Tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0009 events8 affected112 at risk EG0013 events3 affected102 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected112 at risk EG00113 events11 affected102 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected112 at risk EG0013 events3 affected102 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0009 events9 affected112 at risk EG0019 events8 affected102 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG00019 events18 affected112 at risk EG00116 events15 affected102 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected112 at risk EG0017 events6 affected102 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected112 at risk EG0017 events7 affected102 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00028 events24 affected112 at risk EG00132 events27 affected102 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00037 events27 affected112 at risk EG00127 events22 affected102 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00017 events15 affected112 at risk EG0019 events7 affected102 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00031 events27 affected112 at risk EG00116 events16 affected102 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected112 at risk EG0016 events6 affected102 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00036 events28 affected112 at risk EG00177 events53 affected102 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00014 events11 affected112 at risk EG0015 events5 affected102 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00020 events17 affected112 at risk EG00125 events24 affected102 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0008 events7 affected112 at risk EG0017 events6 affected102 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00011 events10 affected112 at risk EG00123 events20 affected102 at risk
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG00026 events20 affected112 at risk EG00160 events41 affected102 at risk
Chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected112 at risk EG00112 events10 affected102 at risk
Chills	General disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected112 at risk EG0013 events3 affected102 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG00049 events39 affected112 at risk EG00138 events33 affected102 at risk
Mucosal inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected112 at risk EG00110 events10 affected102 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG00030 events22 affected112 at risk EG00114 events13 affected102 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00014 events12 affected112 at risk EG0015 events5 affected102 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0009 events8 affected112 at risk EG0015 events5 affected102 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0008 events7 affected112 at risk EG0012 events2 affected102 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG00013 events13 affected112 at risk EG00115 events14 affected102 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG00018 events18 affected112 at risk EG00112 events12 affected102 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected112 at risk EG0018 events8 affected102 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0009 events8 affected112 at risk EG0019 events8 affected102 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected112 at risk EG0016 events4 affected102 at risk
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected112 at risk EG00117 events13 affected102 at risk
Blood urea increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected112 at risk EG0019 events7 affected102 at risk
Lymphocyte count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00016 events11 affected112 at risk EG00112 events8 affected102 at risk
Neutrophil count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00023 events19 affected112 at risk EG00115 events13 affected102 at risk
Platelet count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00018 events16 affected112 at risk EG00115 events9 affected102 at risk
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00016 events16 affected112 at risk EG00114 events14 affected102 at risk
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00017 events11 affected112 at risk EG00119 events11 affected102 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00029 events24 affected112 at risk EG00134 events30 affected102 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected112 at risk EG0017 events6 affected102 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00013 events9 affected112 at risk EG00111 events6 affected102 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0008 events6 affected112 at risk EG0012 events2 affected102 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00010 events9 affected112 at risk EG0018 events6 affected102 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00015 events10 affected112 at risk EG0015 events3 affected102 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00022 events17 affected112 at risk EG00113 events11 affected102 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0008 events6 affected112 at risk EG0017 events5 affected102 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0008 events6 affected112 at risk EG0013 events3 affected102 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00014 events11 affected112 at risk EG0019 events8 affected102 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00011 events9 affected112 at risk EG00111 events9 affected102 at risk
Dysgeusia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00011 events10 affected112 at risk EG0018 events8 affected102 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0009 events9 affected112 at risk EG00118 events13 affected102 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00015 events15 affected112 at risk EG0015 events5 affected102 at risk
Paraesthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected112 at risk EG0014 events4 affected102 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00013 events12 affected112 at risk EG0011 events1 affected102 at risk
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG00021 events18 affected112 at risk EG0018 events7 affected102 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00036 events31 affected112 at risk EG00137 events29 affected102 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00028 events24 affected112 at risk EG00119 events18 affected102 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected112 at risk EG0018 events8 affected102 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected112 at risk EG0012 events2 affected102 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00019 events16 affected112 at risk EG00119 events17 affected102 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected112 at risk EG0019 events9 affected102 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00035 events35 affected112 at risk EG0016 events6 affected102 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00019 events15 affected112 at risk EG00118 events16 affected102 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00027 events22 affected112 at risk EG00116 events14 affected102 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected112 at risk EG0012 events2 affected102 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected112 at risk EG0017 events5 affected102 at risk
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG00011 events11 affected112 at risk EG0017 events6 affected102 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	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
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

ID	Title	Description
BG000	Pembrolizumab + cCRT + Paclitaxel + Carboplatin	Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
BG001	Pembrolizumab + cCRT + Pemetrexed + Cisplatin	Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pembrolizumab + cCRT + Paclitaxel + Carboplatin	Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.	72	112	66	112	106	112
EG001	Pembrolizumab + cCRT + Pemetrexed + Cisplatin	Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.	49	104	46	102	100	102

ID	Term
C582435	pembrolizumab
D017239	Paclitaxel
D002945	Cisplatin
D000068437	Pemetrexed