M7824 With cCRT in Unresectable Stage III Non-small Cell... | NCT03840902

NCT03840902

ID	Type	Description	Link
2018-003265-34	EudraCT Number

Status Module

Name	Class
Merck KGaA, Darmstadt, Germany	INDUSTRY

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cCRT plus M7824 followed by M7824	Experimental	Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.	Drug: M7824 Drug: Etoposide Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin Radiation: Intensity Modulated Radiation Therapy (IMRT)
cCRT plus placebo followed by durvalumab	Active Comparator	Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with placebo matched to M7824 followed by durvalumab.	Drug: Placebo Drug: Durvalumab Drug: Etoposide Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin Radiation: Intensity Modulated Radiation Therapy (IMRT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
M7824	Drug	Participants received intravenous infusion of 1200 milligram (mg) M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator	PFS was defined as the time from randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was analyzed by using the Kaplan-Meier method.	Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events	Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily have a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention.

Eligibility Module

Name	Affiliation	Role
Medical Responsible	Merck KGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of California Irvine Medical Center		Orange	California	92868	United States
UCLA Hematology Oncology - Main Site - 2020 Santa Monica

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36177913	Derived	Huang Y, Zhao JJ, Soon YY, Wong A, Aminkeng F, Ang Y, Asokumaran Y, Low JL, Lee M, Choo JRE, Chan G, Kee A, Tay SH, Goh BC, Soo RA. Real-world experience of consolidation durvalumab after concurrent chemoradiotherapy in stage III non-small cell lung cancer. Thorac Cancer. 2022 Nov;13(22):3152-3161. doi: 10.1111/1759-7714.14667. Epub 2022 Sep 30.

Label	URL
Trial Awareness and Transparency website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 22, 2021	Dec 5, 2023

Arm/Group Information

ID	Title	Description
BG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
BG001	cCRT Plus Placebo Followed by Durvalumab	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00064.7± 9.35 BG00164.9± 8.94 BG00264.8± 9.12

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00020 BG00116 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0005 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

PFS was defined as the time from randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was analyzed by using the Kaplan-Meier method.

Full Analysis Set (FAS) included all participants who were randomized to study treatment.

Posted

Median

Full Range

months

Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 months

ID	Title	Description
OG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
OG001	cCRT Plus Placebo Followed by Durvalumab	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

Units	Counts
Participants	OG00075 OG00178

Title

Denominators

Categories

Title	Measurements
	OG0003.7(1.9 to 5.6) OG0013.7(1.8 to 3.9)

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events

Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily have a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention.

Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention.

Posted

Count of Participants

Participants

Time from randomization up to data cut off (assessed up to 27 months)

ID	Title	Description
OG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

Secondary

Overall Survival (OS)

Overall Survival was defined as the time from randomization to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.

FAS included all participants who were randomized to study treatment.

Posted

Median

Full Range

months

Time from randomization to the date of death due to any cause, assessed up to 27 months

ID	Title	Description
OG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

Secondary

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

ORR was defined as the percentage of participants who had achieved complete response (CR) or partial response (PR) as the best overall response according to RECIST v1.1as adjudicated by the Investigator. CR: Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions.

FAS included all participants who were randomized to study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Time from randomization up to data cut off (assessed up to 27 months)

ID	Title	Description
OG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

Secondary

Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

DOR was defined as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates.

Due to early termination of the study, the data for this outcome measure was not collected.

Posted

Time from first documentation of objective response to the date of first documentation of PD or death due to any cause, assessed approximately up to 27 months

ID	Title	Description
OG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

Secondary

Immediate Observed Serum Concentration at End of Infusion (Ceoi) of M7824

Ceoi is the serum concentration observed immediately at the end of infusion. This was taken directly from the observed M7824 concentration-time data.

Based on recommendations by an external Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study. Subsequently, the data for this outcome measure was not collected and analyzed.

Posted

Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343

ID	Title	Description
OG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

Secondary

Serum Concentration Immediately Before Next Dosing (Ctrough) of M7824

Ctrough was the serum concentration observed immediately before next dosing.

Posted

Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343

ID	Title	Description
OG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

Secondary

Number of Participants With Positive Antidrug Antibodies (ADA)

Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.

Posted

Time from randomization up to data cut off (assessed up to 27 months)

ID	Title	Description
OG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	cCRT Plus M7824 Followed by M7824	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.	13	75	43	74	68	74
EG001	cCRT Plus Placebo Followed by Durvalumab	Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray [Gy]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.	5	78	31	77	72	77

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected74 at risk EG0010 events0 affected77 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events1 affected77 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Myocardial infarction	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Pericardial effusion	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Gastrointestinal vascular malformation haemorrhagic	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0011 events1 affected77 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0016 events3 affected77 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0006 events5 affected74 at risk EG0010 events0 affected77 at risk
Asthenia	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Death	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Disease progression	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Mucosal inflammation	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected77 at risk
Pyrexia	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0013 events2 affected77 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Contrast media allergy	Immune system disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Bacteraemia	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected77 at risk
Cystitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Device related infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0005 events3 affected74 at risk EG0014 events4 affected77 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Sepsis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0011 events1 affected77 at risk
Septic shock	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0003 events2 affected74 at risk EG0010 events0 affected77 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected77 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Radiation mucositis	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0007 events3 affected74 at risk EG0012 events2 affected77 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0012 events2 affected77 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Neutrophil count decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Cerebral infarction	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Thoracic outlet syndrome	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0013 events2 affected77 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0008 events5 affected74 at risk EG0019 events6 affected77 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0010 events0 affected77 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0011 events1 affected77 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Hypotension	Vascular disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG00049 events38 affected74 at risk EG00153 events32 affected77 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG00013 events9 affected74 at risk EG00112 events10 affected77 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected74 at risk EG0013 events3 affected77 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG00027 events20 affected74 at risk EG00118 events15 affected77 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0012 events1 affected77 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG00016 events11 affected74 at risk EG0018 events7 affected77 at risk
Angina pectoris	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events2 affected74 at risk EG0010 events0 affected77 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0011 events1 affected77 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Palpitations	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Pericardial effusion	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0012 events2 affected77 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Tachycardia	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0012 events2 affected77 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected74 at risk EG0017 events7 affected77 at risk
Hypopituitarism	Endocrine disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Hypothyroidism	Endocrine disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0016 events6 affected77 at risk
Thyroiditis	Endocrine disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0013 events3 affected77 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0012 events2 affected77 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0010 events0 affected77 at risk
Abdominal rigidity	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Ascites	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0011 events1 affected77 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG00026 events23 affected74 at risk EG00143 events34 affected77 at risk
Dental caries	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG00014 events12 affected74 at risk EG00113 events12 affected77 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0010 events0 affected77 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0005 events5 affected74 at risk EG0014 events4 affected77 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG00010 events9 affected74 at risk EG0015 events5 affected77 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0012 events2 affected77 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0015 events5 affected77 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG00029 events26 affected74 at risk EG00135 events29 affected77 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0006 events5 affected74 at risk EG0017 events6 affected77 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG00015 events15 affected74 at risk EG00125 events24 affected77 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0010 events0 affected77 at risk
Retching	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0009 events9 affected74 at risk EG0013 events3 affected77 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG00012 events9 affected74 at risk EG0017 events6 affected77 at risk
Asthenia	General disorders	MedDRA 24.0	Non-systematic Assessment	EG00019 events13 affected74 at risk EG0016 events6 affected77 at risk
Catheter site pruritus	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Chest discomfort	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Chest pain	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Chills	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0014 events4 affected77 at risk
Fatigue	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0005 events5 affected74 at risk EG00115 events14 affected77 at risk
Feeling hot	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Gait disturbance	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Generalised oedema	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Hyperthermia	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Infusion site extravasation	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Infusion site reaction	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Malaise	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0006 events5 affected74 at risk EG0016 events6 affected77 at risk
Mucosal haemorrhage	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Mucosal inflammation	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0006 events5 affected74 at risk EG0013 events2 affected77 at risk
Oedema peripheral	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Pain	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Pyrexia	General disorders	MedDRA 24.0	Non-systematic Assessment	EG00022 events18 affected74 at risk EG00111 events10 affected77 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Hypersensitivity	Immune system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Bacteraemia	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Bronchitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Cystitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events1 affected77 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Device related infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Empyema	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Folliculitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0004 events2 affected74 at risk EG0010 events0 affected77 at risk
Fungal skin infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Gastroenteritis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Gingivitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Herpes zoster	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Influenza	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Molluscum contagiosum	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected77 at risk
Oesophageal infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Onychomycosis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Oral candidiasis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Oral fungal infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Peri-implantitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Periodontitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0009 events8 affected74 at risk EG0013 events3 affected77 at risk
Post-acute COVID-19 syndrome	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Respiratory tract infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0012 events2 affected77 at risk
Sinusitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected77 at risk
Tinea infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Tooth abscess	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Tracheitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG00010 events6 affected74 at risk EG0013 events3 affected77 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0013 events3 affected77 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Radiation fibrosis	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Radiation fibrosis - lung	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected77 at risk
Radiation mucositis	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected77 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG00013 events13 affected74 at risk EG00115 events13 affected77 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0007 events7 affected74 at risk EG00112 events9 affected77 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0005 events5 affected74 at risk EG00110 events10 affected77 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG00010 events6 affected74 at risk EG00111 events9 affected77 at risk
Alpha hydroxybutyrate dehydrogenase increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Amylase increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG00011 events5 affected74 at risk EG0013 events1 affected77 at risk
Anti-transglutaminase antibody increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0007 events6 affected74 at risk EG00111 events7 affected77 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0013 events2 affected77 at risk
Blood bilirubin increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0004 events3 affected74 at risk EG0015 events3 affected77 at risk
Blood cholesterol increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0014 events4 affected77 at risk
Blood creatine increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0008 events4 affected74 at risk EG0012 events2 affected77 at risk
Blood creatinine increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected74 at risk EG0014 events3 affected77 at risk
Blood glucose increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0003 events2 affected74 at risk EG0010 events0 affected77 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected77 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Blood triglycerides increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Blood urea increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0005 events2 affected74 at risk EG0019 events5 affected77 at risk
Brain natriuretic peptide increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
C-reactive protein increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 events1 affected74 at risk EG0012 events2 affected77 at risk
Fibrin D dimer increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0007 events5 affected74 at risk EG00113 events7 affected77 at risk
Gastric pH decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected77 at risk
Hepatic enzyme increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Lipase increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0009 events8 affected74 at risk EG0011 events1 affected77 at risk
Lung diffusion test decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Lymphocyte count decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG00016 events11 affected74 at risk EG00123 events13 affected77 at risk
Neutrophil count decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG00028 events17 affected74 at risk EG00136 events20 affected77 at risk
Platelet count decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG00016 events11 affected74 at risk EG00121 events13 affected77 at risk
Procalcitonin increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Protein total decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Prothrombin time prolonged	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected77 at risk
Pulmonary function test decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0012 events2 affected77 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Total bile acids increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Transaminases increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Weight decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0009 events8 affected74 at risk EG0018 events8 affected77 at risk
Weight increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected77 at risk
White blood cell count decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG00037 events24 affected74 at risk EG00159 events29 affected77 at risk
White blood cell count increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG00020 events17 affected74 at risk EG00117 events16 affected77 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0012 events2 affected77 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0013 events2 affected77 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0007 events6 affected74 at risk EG0017 events5 affected77 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected77 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0017 events4 affected77 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events3 affected74 at risk EG0016 events3 affected77 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG00016 events10 affected74 at risk EG0016 events5 affected77 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected74 at risk EG0013 events2 affected77 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0016 events4 affected77 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected74 at risk EG0013 events3 affected77 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0005 events4 affected74 at risk EG0013 events3 affected77 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG00013 events6 affected74 at risk EG00115 events9 affected77 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0005 events5 affected74 at risk EG0010 events0 affected77 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected77 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0007 events7 affected74 at risk EG0013 events3 affected77 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0006 events6 affected74 at risk EG0014 events4 affected77 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0011 events1 affected77 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected77 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0010 events0 affected77 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0005 events4 affected74 at risk EG0010 events0 affected77 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Cerebral microhaemorrhage	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0015 events5 affected77 at risk
Dizziness exertional	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Dizziness postural	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Dysgeusia	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0011 events1 affected77 at risk
Headache	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0015 events4 affected77 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0011 events1 affected77 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Somnolence	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Syncope	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0012 events2 affected77 at risk
Tremor	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Device malfunction	Product Issues	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Anxiety	Psychiatric disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Delirium	Psychiatric disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Depression	Psychiatric disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Insomnia	Psychiatric disorders	MedDRA 24.0	Non-systematic Assessment	EG00010 events9 affected74 at risk EG00111 events9 affected77 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Dysuria	Renal and urinary disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Haematuria	Renal and urinary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0012 events1 affected77 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Proteinuria	Renal and urinary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Renal failure	Renal and urinary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Erection increased	Reproductive system and breast disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG00015 events15 affected74 at risk EG00116 events14 affected77 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events3 affected74 at risk EG0017 events7 affected77 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected77 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG00016 events13 affected74 at risk EG0012 events2 affected77 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0009 events7 affected74 at risk EG0013 events3 affected77 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0009 events6 affected74 at risk EG0016 events6 affected77 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events2 affected74 at risk EG0010 events0 affected77 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0013 events3 affected77 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected77 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected74 at risk EG00112 events10 affected77 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0006 events4 affected74 at risk EG0013 events2 affected77 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0012 events2 affected77 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0006 events6 affected74 at risk EG0017 events7 affected77 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected77 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0015 events4 affected77 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0012 events2 affected77 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0010 events0 affected77 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0007 events5 affected74 at risk EG0011 events1 affected77 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Lichenoid keratosis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG00018 events13 affected74 at risk EG0018 events8 affected77 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected77 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG00025 events19 affected74 at risk EG0017 events6 affected77 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected74 at risk EG0011 events1 affected77 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Hypertension	Vascular disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 events3 affected74 at risk EG0012 events2 affected77 at risk
Hypotension	Vascular disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected74 at risk EG0015 events4 affected77 at risk
Intermittent claudication	Vascular disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected77 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected77 at risk
Phlebitis	Vascular disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk
Phlebitis superficial	Vascular disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected77 at risk

Ancestor Terms

ID	Term
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic
D056831	Coordination Complexes
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D004224	Diterpenes
D013729	Terpenes
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D020266	Radiotherapy, Conformal
D011881	Radiotherapy, Computer-Assisted
D011878	Radiotherapy
D013812	Therapeutics

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
C000613593	durvalumab
D005047	Etoposide
D000068437	Pemetrexed
D016190	Carboplatin
D017239	Paclitaxel
D002945	Cisplatin
D050397	Radiotherapy, Intensity-Modulated