Study to Compare AMG 510 "Proposed INN Sotorasib" With Do... | NCT04303780

NCT04303780

ID	Type	Description	Link
2023-508214-42-00	Other Identifier	CTIS (EU)

Status Module

Label	Type	Description	Intervention Names
AMG 510	Experimental		Drug: AMG 510
Docetaxel	Active Comparator		Drug: Docetaxel

Name	Type	Description	Arm Group Labels	Other Names
AMG 510	Drug	21 day cycles	AMG 510
Docetaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.	Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pacific Cancer Medical Center Inc		Anaheim	California	92801	United States
City of Hope National Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39303400	Background	Waterhouse DM, Rothschild S, Dooms C, Mennecier B, Bozorgmehr F, Majem M, van den Heuvel MH, Linardou H, Chul Cho B, Roberts-Thomson R, Tanaka K, Blais N, Schvartsman G, Holmskov Hansen K, Chmielewska I, Forster MD, Giannopoulou C, Stollenwerk B, Obiozor CC, Wang Y, Novello S. Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation. Lung Cancer. 2024 Oct;196:107921. doi: 10.1016/j.lungcan.2024.107921. Epub 2024 Aug 6.
39846981

Label	URL
AmgenTrials clinical trials website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AMG 510	Participants with previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with centrally confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation received 960 mg of AMG 510 orally via tablets once a day (QD) in each 21 day cycle.
FG001

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	Jan 6, 2022	Apr 17, 2023

Arm/Group Information

ID	Title	Description
BG000	AMG 510	Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 960 mg of AMG 510 orally via tablets QD in each 21 day cycle.
BG001	Docetaxel	Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
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
	BG00063.4± 9.9 BG00163.6± 9.1 BG00263.5± 9.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00062 BG00179 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0005 BG0019 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)

PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.

Measured in the Full Analysis Set (FAS), which included all randomized participants.

Posted

Median

95% Confidence Interval

months

Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months

ID	Title	Description
OG000	AMG 510	Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 960 mg of AMG 510 orally via tablets QD in each 21 day cycle.
OG001	Docetaxel	Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).

Units	Counts
Participants	OG000171 OG001174

Title

Denominators

Categories

Title	Measurements
	OG0005.62(4.27 to 7.75) OG0014.47(3.02 to 5.68)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.002		Hazard Ratio (HR)	0.663			2-Sided	95	0.509	0.864					Equivalence	A hazard ratio <1.0 indicates a lower average event rate and a longer PFS for AMG 510 relative to docetaxel. P-value was calculated using a stratified log-rank test.

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	Docetaxel	Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).	78	174	67	151	129	151
EG001	AMG 510	Participants with previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with centrally confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation received 960 mg of AMG 510 orally via tablets once a day (QD) in each 21 day cycle.	109	171	91	169	151	169
EG002	Docetaxel, Then Switched to AMG 510	Participants who were randomized to originally receive docetaxel, who were determined to have radiological progression according to RECIST v1.1 by the investigator and progressive disease confirmed by independent central imaging review, and switched to receive AMG 510. Alternatively, participants could switch from docetaxel to receive AMG 510 if an early efficacy of the study is noted by the data monitoring committee.	17	46	26	46	35	46

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0005 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0007 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Angina pectoris	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Cardiac arrest	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Cardiac failure	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Coronary artery disease	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Myocardial infarction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Myocarditis	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Pericarditis	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Adrenal cortex necrosis	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Retinal detachment	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0013 affected169 at risk EG0021 affected46 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Colitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0015 affected169 at risk EG0020 affected46 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Ileus	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0012 affected169 at risk EG0022 affected46 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0012 affected169 at risk EG0020 affected46 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Chest pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0013 affected169 at risk EG0020 affected46 at risk
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
General physical health deterioration	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Malaise	General disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Oedema peripheral	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0013 affected169 at risk EG0020 affected46 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0021 affected46 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0012 affected169 at risk EG0020 affected46 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0012 affected169 at risk EG0020 affected46 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Appendicitis perforated	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Atypical pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0012 affected169 at risk EG0020 affected46 at risk
Cellulitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Diverticulitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0012 affected169 at risk EG0020 affected46 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Osteomyelitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Peritonitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG00010 affected151 at risk EG0011 affected169 at risk EG0022 affected46 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Pneumonia legionella	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Skin infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0021 affected46 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0012 affected169 at risk EG0021 affected46 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Blood bilirubin increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
General physical condition abnormal	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Liver function test increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Neutrophil count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0021 affected46 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Food intolerance	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0022 affected46 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0012 affected169 at risk EG0021 affected46 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0012 affected169 at risk EG0021 affected46 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0012 affected169 at risk EG0021 affected46 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0005 affected151 at risk EG00118 affected169 at risk EG0029 affected46 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0012 affected169 at risk EG0021 affected46 at risk
Non-small cell lung cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Tumour hyperprogression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0012 affected169 at risk EG0020 affected46 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Aphasia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Cerebellar syndrome	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Cerebral infarction	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Hemiparesis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Loss of consciousness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Paraplegia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Sciatica	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Seizure	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Spinal cord compression	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Delirium	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0021 affected46 at risk
Haematuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Renal failure	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Renal injury	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0021 affected46 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Bronchostenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0012 affected169 at risk EG0020 affected46 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 affected151 at risk EG0012 affected169 at risk EG0022 affected46 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Paraneoplastic pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0021 affected46 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0012 affected169 at risk EG0020 affected46 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG0011 affected169 at risk EG0021 affected46 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Mucocutaneous rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Hypotension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Intermittent claudication	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG0010 affected169 at risk EG0020 affected46 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected151 at risk EG0011 affected169 at risk EG0021 affected46 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG00030 affected151 at risk EG00128 affected169 at risk EG0025 affected46 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG00014 affected151 at risk EG0013 affected169 at risk EG0022 affected46 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0009 affected151 at risk EG00120 affected169 at risk EG0023 affected46 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0005 affected151 at risk EG00111 affected169 at risk EG0023 affected46 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG00029 affected151 at risk EG00122 affected169 at risk EG0023 affected46 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG00037 affected151 at risk EG00170 affected169 at risk EG00214 affected46 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG00036 affected151 at risk EG00143 affected169 at risk EG0026 affected46 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG00019 affected151 at risk EG0013 affected169 at risk EG0020 affected46 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG00015 affected151 at risk EG00122 affected169 at risk EG0022 affected46 at risk
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG00021 affected151 at risk EG00116 affected169 at risk EG0024 affected46 at risk
Chest pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected151 at risk EG00112 affected169 at risk EG0022 affected46 at risk
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG00043 affected151 at risk EG00127 affected169 at risk EG0026 affected46 at risk
Malaise	General disorders	MedDRA 25.0	Systematic Assessment	EG0009 affected151 at risk EG0014 affected169 at risk EG0020 affected46 at risk
Mucosal inflammation	General disorders	MedDRA 25.0	Systematic Assessment	EG00011 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Oedema	General disorders	MedDRA 25.0	Systematic Assessment	EG0008 affected151 at risk EG0013 affected169 at risk EG0020 affected46 at risk
Oedema peripheral	General disorders	MedDRA 25.0	Systematic Assessment	EG00019 affected151 at risk EG0014 affected169 at risk EG0022 affected46 at risk
Pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0009 affected151 at risk EG0016 affected169 at risk EG0022 affected46 at risk
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG00018 affected151 at risk EG0018 affected169 at risk EG0021 affected46 at risk
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0005 affected151 at risk EG0012 affected169 at risk EG0025 affected46 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG00117 affected169 at risk EG0024 affected46 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected151 at risk EG00117 affected169 at risk EG0023 affected46 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0003 affected151 at risk EG00113 affected169 at risk EG0023 affected46 at risk
Weight decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0007 affected151 at risk EG0019 affected169 at risk EG0022 affected46 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG00029 affected151 at risk EG00139 affected169 at risk EG0025 affected46 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0008 affected151 at risk EG0014 affected169 at risk EG0020 affected46 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0004 affected151 at risk EG00112 affected169 at risk EG0023 affected46 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0008 affected151 at risk EG0015 affected169 at risk EG0020 affected46 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG00021 affected151 at risk EG00126 affected169 at risk EG0024 affected46 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG00016 affected151 at risk EG00123 affected169 at risk EG0024 affected46 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected151 at risk EG0019 affected169 at risk EG0020 affected46 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0008 affected151 at risk EG0012 affected169 at risk EG0020 affected46 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG00015 affected151 at risk EG0018 affected169 at risk EG0021 affected46 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0008 affected151 at risk EG00111 affected169 at risk EG0022 affected46 at risk
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0007 affected151 at risk EG00110 affected169 at risk EG0023 affected46 at risk
Dysgeusia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG00014 affected151 at risk EG0014 affected169 at risk EG0020 affected46 at risk
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG00013 affected151 at risk EG00112 affected169 at risk EG0022 affected46 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG00016 affected151 at risk EG0011 affected169 at risk EG0020 affected46 at risk
Insomnia	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0008 affected151 at risk EG0019 affected169 at risk EG0022 affected46 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG00025 affected151 at risk EG00122 affected169 at risk EG0024 affected46 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG00025 affected151 at risk EG00130 affected169 at risk EG0025 affected46 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG00035 affected151 at risk EG0013 affected169 at risk EG0020 affected46 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0007 affected151 at risk EG00115 affected169 at risk EG0022 affected46 at risk

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes