Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Axitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

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The objective of this study is to monitor the usage of INLYTA® in real practice, including the adverse events associated with INLYTA®.

Investigators can choose any patient who is within the scope of I/E criteria

Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea

POST MARKETING SURVEILLANCE STUDY TO OBSERVE SAFETY AND EFFICACY OF INLYTA (REGISTERED)

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Inlyta was assessed by the physician.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta. SADR was any SAE that is attributed to Inlyta. Relatedness to Inlyta was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Severity was graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 where, Grade 1: mild; Grade 2: moderate; Grade 3:severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. One participant may experience more than one event hence, one participant may be included in more than one category specified below.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Inlyta were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unaccessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. If the AEs were not related to Inlyta, physicians were required to indicate the most appropriate cause of AEs from the following: disease under the study, other disease, concomitant treatment drug or non-drug and others.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The action taken with study drug due to AEs included discontinuation, dosage reduced, no change, unknown and not applicable. One participant may experience more than one event hence, one participant may be included in more than one category specified below.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (\<) 60 years, greater than or equal to (\>=) 60 and \< 70 years and \>= 70 years; pediatric (\<19 years); geriatric (\>=65 years); classification: outpatient and inpatient were reported in the outcome measure.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following characteristics: duration of aRCC: \< 30 months, \>= 30 months and \< 60 months,\>= 60 months; cell component of aRCC : clear cell ,other; metastasis: yes,no; site of metastasis: liver, lung, bone, brain, skin, lymph nodes, other; primary lesion surgery: done and not done; medical history: yes and no; renal impairment: yes and no; hepatic impairment: yes and no; allergic history: yes and no; prior chemotherapy: yes and no; prior immunotherapy: yes and no; prior radiation therapy: yes and no; concomitant medication: yes and no; duration of administration: \< 90 days, \>=90 and \<180 days and \>= 180 days; daily average dose: \<10 and \>=10 milligrams per day (mg/day).

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta.

Tumor response based on RECIST 1.1 was defined as: complete response (CR): complete disappearance of all target and non-target lesions. All lymph nodes must be non-pathological in size (\<10 mm short axis); partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered a sign of progression; stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study and not done.

Objective response (OR) was defined as the achievement of partial or complete response to therapy based on RECIST 1.1. CR: complete disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

OR was defined as the number of participants who have a partial or complete response to therapy. CR: complete disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Number of participants with objective response categorized according to the following demographic characteristics was presented in this outcome measure: sex: male and female; age: \< 60 years, \>= 60 and \< 70 years, \>= 70 years; pediatric (\<19 years); geriatric (\>=65 years); classification: outpatient and inpatient.

OR was defined as the number of participants who have a partial or complete response to therapy. Number of participants with OR classified according to the following characteristics included duration of aRCC: \< 30 months, \>= 30 months and \< 60 months and \>= 60 months; cell component of aRCC : clear cell and other; metastasis: yes and no; site of metastasis: liver, lung, bone, brain, skin, lymph nodes and other; primary lesion surgery: done and not done; medical history: yes and no; renal impairment: yes and no; hepatic impairment: yes and no; allergic history: yes and no; prior chemotherapy: yes and no; prior immunotherapy: yes and no; prior radiation therapy: yes and no; concomitant medication: yes and no; duration of administration: \< 90 days, \>=90 and \<180 days and \>= 180 days; daily average dose: \<10 and \>=10 mg/day.

OR was defined as the achievement of partial or complete response to therapy based on RECIST 1.1. CR: complete disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

PFS was defined as the time from first dose of Inlyta to first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was determined from tumor assessment criteria(where data meet the criteria for progressive disease \[PD\]), or from death report on case report forms (CRFs). PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered a sign of progression.

TTP was defined as the time from the start of Inlyta treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. Disease progression was defined as \>20% increase in sum of longest diameter of target lesions compared to baseline.

Pfizer

An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety analysis set included all participants who had been administered Inlyta at least once and evaluated for safety related outcomes at least once.

Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 mg or 5 mg tablets for first time or who were already on Inlyta as part of routine practice at Korean health care centers were observed during this PMS study.

Inlyta

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Duration of aRCC was calculated as the start date of first administration of Inlyta minus date of initial diagnosis + 1 divided by 30.4375.

Duration of Advanced Renal Cell Carcinoma (aRCC)

Clear cell

Other

Cell component of aRCC were classified as clear cell and other.

Number of Participants Categorized According to Cell Component of aRCC

Liver

Lung

Bone

Brain

Skin

Lymph nodes

None

Number of participants according to the sites of metastasis including liver, lung, bone, brain, skin, lymph nodes, other and none were reported. Participants could have more than one site of metastasis.

Number of Participants According to Sites of Metastasis

Number of Participants who Underwent Primary Lesion Surgery

Number of participants with past or present disease (medical history) were reported in this study specific characteristic.

Number of Participants With Medical History

Number of Participants With Renal Impairment

Number of Participants With Hepatic Impairment

Number of Participants With Allergic History

Number of participants who received chemotherapy prior to Inlyta were reported.

Number of Participants who Received Chemotherapy Prior to Inlyta

Number of participants who received immunotherapy prior to Inlyta were reported.

Number of Participants who Received Immunotherapy Prior to Inlyta

Number of participants who received radiation therapy prior to Inlyta were reported.

Number of Participants who Received Radiation Therapy Prior to Inlyta

Number of participants who received concomitant medication were reported.

Number of Participants who Received Concomitant Medication

Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once.

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ADRs

SAEs

SADRs

Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)

Unexpected AEs

Unexpected ADRs

Unexpected SAEs

Unexpected SADRs

Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs

Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants without missing date or month of AE onset.

Duration of Adverse Events

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Number of Participants With Adverse Events by Their Severity

Recovered

Recovered with sequelae

Recovering

Not recovered

Unknown

Number of Participants With Adverse Events by Their Outcome

Results in death

Is life-threatening

Requires inpatient hospitalization or prolongation of hospitalization

Results in persistent or significant disability/incapacity

Results in congenital anomaly/birth defect

Other important medical event

Number of Participants With Adverse Events by Their Seriousness Criteria

Certain

Probable/likely

Possible

Unlikely

Conditional/unclassified

Unaccessible/unclassifiable

Number of Participants With Adverse Events by Their Causality to Inlyta

Disease under the study

Other disease

Concomitant treatment drug or non-drug

Others

Number of Participants With Adverse Events by Their Other Causality

Discontinuation

Dosage reduced

No change

Not applicable

Number of Participants With Adverse Events by Their Action Taken With Study Drug

Sex: Male

Sex: Female

Age: < 60 years

Age: >= 60 years and < 70 years

Age: >= 70 years

Pediatric(< 19 years)

Geriatric(>= 65 years)

Classification: Outpatient

Classification: Inpatient

Number of Participants With Adverse Events According to Demographic Characteristics

Duration of aRCC: < 30 months

Duration of aRCC: >= 30 months and < 60 months

Duration of aRCC: >= 60 months

Cell component of aRCC: Clear cell

Cell component of aRCC: Other

Metastasis: Yes

Metastasis: No

Metastasis site: Liver

Metastasis site: Lung

Metastasis site: Bone

Metastasis site: Brain

Metastasis site: Skin

Metastasis site: Lymph nodes

Metastasis site: Other

Primary lesion surgery: Done

Primary lesion surgery: Not done

Medical history: Yes

Medical history: No

Renal impairment: Yes

Renal impairment: No

Hepatic impairment: Yes

Hepatic impairment: No

Allergic history: Yes

Allergic history: No

Prior chemotherapy: Yes

Prior chemotherapy: No

Prior immunotherapy: Yes

Prior immunotherapy: No

Prior radiation therapy: Yes

Prior radiation therapy: No

Concomitant medication: Yes

Concomitant medication: No

Duration of administration: < 90 days

Duration of administration: >= 90 days and <180 days

Duration of administration: >= 180 days

Daily average dose: < 10 mg/day

Daily average dose: >= 10 mg/day

Safety analysis set included all participants who were administered Inlyta at least once and evaluated for safety related outcomes at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. "Number Analyzed" refers to number of participants evaluable for the specified categories.

Number of Participants With Adverse Events According to Other Baseline Characteristics

Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis

Geriatric - AEs

Geriatric - ADRs

Renal impairment - AEs

Renal impairment - ADRs

Hepatic impairment - AEs

Hepatic impairment - ADRs

Special participant population included geriatric participants (aged \>=65 years), participants with renal or hepatic impairment who were administered Inlyta at least once. "Number Analyzed" refers to number of participants evaluable for the specified categories.

Number of Participants With AEs and ADRs - Special Participant Population

Complete response (CR)

Partial response (PR)

Progressive disease (PD)

Stable disease (SD)

Not done

Efficacy analysis set included all participants who had been administered Inlyta at least once.

Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea	NCT02156895	Advanced Renal ...	Axitinib	18 Years -	Pfizer
Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea	NCT02156895	Advanced Renal ...	Axitinib	18 Years -	Pfizer

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