Temsirolimus Versus Sorafenib As Second-Line Therapy In P... | NCT00474786

NCT00474786

ID	Type	Description	Link
B1771003

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: Sorafenib
2	Experimental		Drug: temsirolimus (Torisel)

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib	Drug	Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS)	Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.	Baseline up to 24 Months

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) by Investigator Assessment	Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.	Baseline up to 24 Months
Percentage of Participants With Tumor Response

Other Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.	Baseline up to 24 months

Eligibility Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Duarte	California	91010	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28410911	Derived	de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
27238653	Derived

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Temsirolimus	Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Temsirolimus	Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
BG001	Sorafenib	Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the 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
	OG0004.28(4.01 to 5.43) OG0013.91(2.80 to 4.21)

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		0.1933	Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.	Cox Proportional Hazard	0.87			2-Sided	95	0.71	1.07			Hazard ratio less than (<) 1 means temsirolimus (TEMSR) is at lower risk.	No	Superiority or Other

Secondary

Progression Free Survival (PFS) by Investigator Assessment

Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.

ITT population

Posted

Median

95% Confidence Interval

months

Baseline up to 24 Months

ID	Title	Description
OG000	Temsirolimus	Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
OG001	Sorafenib	Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.

Units	Counts
Participants

Secondary

Percentage of Participants With Tumor Response

Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

ITT population

Posted

Number

95% Confidence Interval

percentage of participants

Baseline up to 24 Months

ID	Title	Description
OG000	Temsirolimus	Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
OG001	Sorafenib	Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.

Secondary

Overall Survival (OS)

Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.

ITT population

Posted

Median

95% Confidence Interval

months

Baseline to date of death from any cause (up to 24 months)

ID	Title	Description
OG000	Temsirolimus	Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
OG001	Sorafenib	Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.

Units	Counts
Participants

Secondary

Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment

PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.

ITT population

Posted

Number

percentage of participants

Weeks 12, 24, and 36

ID	Title	Description
OG000	Temsirolimus	Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
OG001	Sorafenib	Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.

Units	Counts
Participants

Secondary

Duration of Response (DR)

Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.

ITT population

Posted

Median

95% Confidence Interval

months

Baseline up to 24 Months

ID	Title	Description
OG000	Temsirolimus	Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
OG001	Sorafenib	Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.

Units	Counts
Participants

Other Pre-specified

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Safety population: all participants who received at least 1 dose of test article.

Posted

Number

participants

Baseline up to 24 months

ID	Title	Description
OG000	Temsirolimus	Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
OG001	Sorafenib	Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.

Units

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	Temsirolimus	Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.			104	249	243	249
EG001	Sorafenib	Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.			87	252	249	252

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG0005 affected249 at risk EG0014 affected252 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0013 affected252 at risk
Atrial flutter	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Cardiac arrest	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Cardiac tamponade	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0011 affected252 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0010 affected252 at risk
Myocardial infarction	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0014 affected252 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Palpitations	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Pericardial effusion	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Prinzmetal angina	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Hyperthyroidism	Endocrine disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Retinal artery occlusion	Eye disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0011 affected252 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0007 affected249 at risk EG0011 affected252 at risk
Ascites	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0003 affected249 at risk EG0011 affected252 at risk
Constipation	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0011 affected252 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0003 affected249 at risk EG0011 affected252 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0010 affected252 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Intestinal ulcer perforation	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Nausea	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Oesophageal hypomotility	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Vomiting	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0006 affected249 at risk EG0014 affected252 at risk
Asthenia	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0003 affected249 at risk EG0011 affected252 at risk
Chest pain	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0013 affected252 at risk
Fatigue	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0014 affected252 at risk
General physical health deterioration	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0008 affected249 at risk EG0019 affected252 at risk
Multi-organ failure	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Oedema peripheral	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0010 affected252 at risk
Pain	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0012 affected252 at risk
Performance status decreased	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Pyrexia	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0007 affected249 at risk EG0014 affected252 at risk
Sudden death	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0011 affected252 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Cholecystitis acute	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Cholestasis	Hepatobiliary disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Gallbladder obstruction	Hepatobiliary disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Anaphylactic reaction	Immune system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Drug hypersensitivity	Immune system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Abdominal infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Abscess intestinal	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Anal abscess	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Bronchitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Chest wall abscess	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Cholangitis suppurative	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Device related infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0010 affected252 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Hepatitis B	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Herpes zoster	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Infectious pleural effusion	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Lobar pneumonia	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0010 affected252 at risk
Lung infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Perirectal abscess	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Pharyngitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Pneumonia	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0007 affected249 at risk EG0017 affected252 at risk
Pneumonia influenzal	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Pneumonia legionella	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Respiratory tract infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Sepsis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0012 affected252 at risk
Septic shock	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Subcutaneous abscess	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Tooth abscess	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Urosepsis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Wound infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Radiation mucositis	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Alanine aminotransferase increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0012 affected252 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0013 affected252 at risk
Blood potassium increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Prostatic specific antigen increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Weight decreased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0012 affected252 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0007 affected249 at risk EG0016 affected252 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0013 affected252 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0011 affected252 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0013 affected252 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0010 affected252 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0013 affected252 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0011 affected252 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0013 affected252 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0012 affected252 at risk
Cerebral infarction	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0010 affected252 at risk
Cognitive disorder	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Convulsion	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Headache	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0011 affected252 at risk
Hypoaesthesia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Paraesthesia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Spinal cord compression	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0012 affected252 at risk
Syncope	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Completed suicide	Psychiatric disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0011 affected252 at risk
Confusional state	Psychiatric disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0013 affected252 at risk
Haematuria	Renal and urinary disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Renal failure	Renal and urinary disorders	MedDRA v15.1	Non-systematic Assessment	EG0004 affected249 at risk EG0011 affected252 at risk
Renal failure acute	Renal and urinary disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0011 affected252 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Urinary retention	Renal and urinary disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0010 affected252 at risk
Prostatic haemorrhage	Reproductive system and breast disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0007 affected249 at risk EG0018 affected252 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0010 affected252 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0010 affected252 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0007 affected249 at risk EG0015 affected252 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0007 affected249 at risk EG0010 affected252 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0003 affected249 at risk EG0010 affected252 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG0012 affected252 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0012 affected252 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Lung operation	Surgical and medical procedures	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Medical device implantation	Surgical and medical procedures	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Haematoma	Vascular disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected249 at risk EG0011 affected252 at risk
Haemorrhage	Vascular disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Hypertension	Vascular disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Hypotension	Vascular disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk
Thrombosis	Vascular disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected249 at risk EG0010 affected252 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG00083 affected249 at risk EG00134 affected252 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG00021 affected249 at risk EG0018 affected252 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG00023 affected249 at risk EG0015 affected252 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00074 affected249 at risk EG001156 affected252 at risk
Nausea	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00081 affected249 at risk EG00171 affected252 at risk
Constipation	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00057 affected249 at risk EG00155 affected252 at risk
Vomiting	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00053 affected249 at risk EG00145 affected252 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00033 affected249 at risk EG00141 affected252 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00054 affected249 at risk EG00118 affected252 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00014 affected249 at risk EG00125 affected252 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00015 affected249 at risk EG00118 affected252 at risk
Oral pain	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00013 affected249 at risk EG0015 affected252 at risk
Fatigue	General disorders	MedDRA v15.1	Non-systematic Assessment	EG00099 affected249 at risk EG00184 affected252 at risk
Asthenia	General disorders	MedDRA v15.1	Non-systematic Assessment	EG00063 affected249 at risk EG00163 affected252 at risk
Mucosal inflammation	General disorders	MedDRA v15.1	Non-systematic Assessment	EG00074 affected249 at risk EG00135 affected252 at risk
Pyrexia	General disorders	MedDRA v15.1	Non-systematic Assessment	EG00053 affected249 at risk EG00128 affected252 at risk
Oedema peripheral	General disorders	MedDRA v15.1	Non-systematic Assessment	EG00057 affected249 at risk EG00114 affected252 at risk
Chest pain	General disorders	MedDRA v15.1	Non-systematic Assessment	EG00023 affected249 at risk EG00125 affected252 at risk
Pain	General disorders	MedDRA v15.1	Non-systematic Assessment	EG00020 affected249 at risk EG00116 affected252 at risk
Oedema	General disorders	MedDRA v15.1	Non-systematic Assessment	EG00017 affected249 at risk EG0015 affected252 at risk
Chills	General disorders	MedDRA v15.1	Non-systematic Assessment	EG00015 affected249 at risk EG0016 affected252 at risk
Nasopharyngitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG00024 affected249 at risk EG00116 affected252 at risk
Weight decreased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG00035 affected249 at risk EG00151 affected252 at risk
Blood creatinine increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG00032 affected249 at risk EG0016 affected252 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG00022 affected249 at risk EG00115 affected252 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG00026 affected249 at risk EG00111 affected252 at risk
Alanine aminotransferase increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG00018 affected249 at risk EG00117 affected252 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG00016 affected249 at risk EG00113 affected252 at risk
Haemoglobin decreased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG00019 affected249 at risk EG0019 affected252 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG00076 affected249 at risk EG00194 affected252 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG00053 affected249 at risk EG00118 affected252 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG00051 affected249 at risk EG00116 affected252 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG00045 affected249 at risk EG00113 affected252 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG00028 affected249 at risk EG00130 affected252 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG00014 affected249 at risk EG00114 affected252 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG00010 affected249 at risk EG00117 affected252 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG00011 affected249 at risk EG00114 affected252 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG00015 affected249 at risk EG0019 affected252 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00050 affected249 at risk EG00136 affected252 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00046 affected249 at risk EG00129 affected252 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00031 affected249 at risk EG00138 affected252 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00024 affected249 at risk EG00120 affected252 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00018 affected249 at risk EG00122 affected252 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00020 affected249 at risk EG00117 affected252 at risk
Headache	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG00032 affected249 at risk EG00144 affected252 at risk
Dizziness	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG00020 affected249 at risk EG00120 affected252 at risk
Dysgeusia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG00022 affected249 at risk EG00110 affected252 at risk
Paraesthesia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG00014 affected249 at risk EG00110 affected252 at risk
Insomnia	Psychiatric disorders	MedDRA v15.1	Non-systematic Assessment	EG00015 affected249 at risk EG00116 affected252 at risk
Anxiety	Psychiatric disorders	MedDRA v15.1	Non-systematic Assessment	EG00013 affected249 at risk EG0017 affected252 at risk
Dysuria	Renal and urinary disorders	MedDRA v15.1	Non-systematic Assessment	EG00013 affected249 at risk EG0017 affected252 at risk
Pollakiuria	Renal and urinary disorders	MedDRA v15.1	Non-systematic Assessment	EG00013 affected249 at risk EG0013 affected252 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00085 affected249 at risk EG00157 affected252 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00067 affected249 at risk EG00140 affected252 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00051 affected249 at risk EG00113 affected252 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0005 affected249 at risk EG00138 affected252 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00023 affected249 at risk EG00115 affected252 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00015 affected249 at risk EG0017 affected252 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00019 affected249 at risk EG0010 affected252 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG00014 affected249 at risk EG0015 affected252 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG000104 affected249 at risk EG00187 affected252 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00011 affected249 at risk EG001131 affected252 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00063 affected249 at risk EG00164 affected252 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0005 affected249 at risk EG00178 affected252 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00040 affected249 at risk EG00136 affected252 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00015 affected249 at risk EG00129 affected252 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG00019 affected249 at risk EG0010 affected252 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected249 at risk EG00117 affected252 at risk
Hypertension	Vascular disorders	MedDRA v15.1	Non-systematic Assessment	EG0008 affected249 at risk EG00137 affected252 at risk

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002292	Carcinoma, Renal Cell
D009362	Neoplasm Metastasis

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009536	Niacinamide
D009539	Nicotinic Acids
D000147	Acids, Heterocyclic
D006571	Heterocyclic Compounds
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring