Trial Outcomes & Findings for Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea (NCT NCT02156895)

Last Updated: 2024-03-08

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

111 participants

Primary outcome timeframe

From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)

Results posted on

2024-03-08

Participant Flow

Participants with advanced renal cell carcinoma (aRCC) prescribed with Inlyta (axitinib) for first time or who were already on Inlyta during study period as part of routine practice at Korean health care centers were observed. This study was to be conducted for 6 years from the approval date of 22 Aug 2012 to 21 Aug 2018. On May 2018, Ministry of Food and Drug Safety (MFDS) has granted 3 additional years for the study, for total of 9 years for the study period.

Participant milestones

Participant milestones
Measure	Inlyta Participants with aRCC after failure of one prior systemic therapy and who were prescribed with Inlyta 1 milligram (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.
Overall Study STARTED	111
Overall Study COMPLETED	111
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inlyta n=111 Participants 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.
Age, Continuous	64.92 Years STANDARD_DEVIATION 10.44 • n=111 Participants
Sex: Female, Male Female	21 Participants n=111 Participants
Sex: Female, Male Male	90 Participants n=111 Participants
Duration of Advanced Renal Cell Carcinoma (aRCC)	46.84 Months STANDARD_DEVIATION 55.21 • n=111 Participants
Number of Participants Categorized According to Cell Component of aRCC Clear cell	110 Participants n=111 Participants
Number of Participants Categorized According to Cell Component of aRCC Other	1 Participants n=111 Participants
Number of Participants According to Sites of Metastasis Liver	7 Participants n=111 Participants
Number of Participants According to Sites of Metastasis Lung	84 Participants n=111 Participants
Number of Participants According to Sites of Metastasis Bone	31 Participants n=111 Participants
Number of Participants According to Sites of Metastasis Brain	9 Participants n=111 Participants
Number of Participants According to Sites of Metastasis Skin	2 Participants n=111 Participants
Number of Participants According to Sites of Metastasis Lymph nodes	19 Participants n=111 Participants
Number of Participants According to Sites of Metastasis Other	23 Participants n=111 Participants
Number of Participants According to Sites of Metastasis None	2 Participants n=111 Participants
Number of Participants who Underwent Primary Lesion Surgery	77 Participants n=111 Participants
Number of Participants With Medical History	101 Participants n=111 Participants
Number of Participants With Renal Impairment	9 Participants n=111 Participants
Number of Participants With Hepatic Impairment	4 Participants n=111 Participants
Number of Participants With Allergic History	6 Participants n=111 Participants
Number of Participants who Received Chemotherapy Prior to Inlyta	111 Participants n=111 Participants
Number of Participants who Received Immunotherapy Prior to Inlyta	1 Participants n=111 Participants
Number of Participants who Received Radiation Therapy Prior to Inlyta	26 Participants n=111 Participants
Number of Participants who Received Concomitant Medication	109 Participants n=111 Participants

PRIMARY outcome

Timeframe: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)

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

Outcome measures

Outcome measures
Measure	Inlyta n=111 Participants 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.
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) AEs	92 Participants
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) ADRs	79 Participants
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) SAEs	14 Participants
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) SADRs	7 Participants

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Inlyta n=111 Participants 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.
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs Unexpected SADRs	0 Participants
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs Unexpected AEs	34 Participants
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs Unexpected ADRs	16 Participants
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs Unexpected SAEs	4 Participants

PRIMARY outcome

Population: 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.

Outcome measures

Outcome measures
Measure	Inlyta n=49 Participants 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.
Duration of Adverse Events	28 Days Interval 0.0 to 475.0

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Inlyta n=92 Participants 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.
Number of Participants With Adverse Events by Their Severity Grade 1	68 Participants
Number of Participants With Adverse Events by Their Severity Grade 2	54 Participants
Number of Participants With Adverse Events by Their Severity Grade 3	26 Participants
Number of Participants With Adverse Events by Their Severity Grade 4	1 Participants
Number of Participants With Adverse Events by Their Severity Grade 5	2 Participants

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Inlyta n=92 Participants 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.
Number of Participants With Adverse Events by Their Outcome Recovered	61 Participants
Number of Participants With Adverse Events by Their Outcome Recovered with sequelae	1 Participants
Number of Participants With Adverse Events by Their Outcome Recovering	38 Participants
Number of Participants With Adverse Events by Their Outcome Not recovered	23 Participants
Number of Participants With Adverse Events by Their Outcome Unknown	12 Participants

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Inlyta n=92 Participants 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.
Number of Participants With Adverse Events by Their Seriousness Criteria Results in death	2 Participants
Number of Participants With Adverse Events by Their Seriousness Criteria Is life-threatening	0 Participants
Number of Participants With Adverse Events by Their Seriousness Criteria Requires inpatient hospitalization or prolongation of hospitalization	14 Participants
Number of Participants With Adverse Events by Their Seriousness Criteria Results in persistent or significant disability/incapacity	0 Participants
Number of Participants With Adverse Events by Their Seriousness Criteria Results in congenital anomaly/birth defect	0 Participants
Number of Participants With Adverse Events by Their Seriousness Criteria Other important medical event	2 Participants

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Inlyta n=92 Participants 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.
Number of Participants With Adverse Events by Their Causality to Inlyta Certain	1 Participants
Number of Participants With Adverse Events by Their Causality to Inlyta Probable/likely	7 Participants
Number of Participants With Adverse Events by Their Causality to Inlyta Possible	77 Participants
Number of Participants With Adverse Events by Their Causality to Inlyta Unlikely	35 Participants
Number of Participants With Adverse Events by Their Causality to Inlyta Conditional/unclassified	2 Participants
Number of Participants With Adverse Events by Their Causality to Inlyta Unaccessible/unclassifiable	1 Participants

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Inlyta n=92 Participants 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.
Number of Participants With Adverse Events by Their Other Causality Disease under the study	4 Participants
Number of Participants With Adverse Events by Their Other Causality Other disease	10 Participants
Number of Participants With Adverse Events by Their Other Causality Concomitant treatment drug or non-drug	2 Participants
Number of Participants With Adverse Events by Their Other Causality Others	26 Participants

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Inlyta n=92 Participants 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.
Number of Participants With Adverse Events by Their Action Taken With Study Drug Discontinuation	19 Participants
Number of Participants With Adverse Events by Their Action Taken With Study Drug Dosage reduced	34 Participants
Number of Participants With Adverse Events by Their Action Taken With Study Drug No change	75 Participants
Number of Participants With Adverse Events by Their Action Taken With Study Drug Unknown	1 Participants
Number of Participants With Adverse Events by Their Action Taken With Study Drug Not applicable	8 Participants

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Inlyta n=92 Participants 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.
Number of Participants With Adverse Events According to Demographic Characteristics Age: >= 60 years and < 70 years	34 Participants
Number of Participants With Adverse Events According to Demographic Characteristics Classification: Inpatient	6 Participants
Number of Participants With Adverse Events According to Demographic Characteristics Sex: Male	71 Participants
Number of Participants With Adverse Events According to Demographic Characteristics Sex: Female	21 Participants
Number of Participants With Adverse Events According to Demographic Characteristics Age: < 60 years	28 Participants
Number of Participants With Adverse Events According to Demographic Characteristics Age: >= 70 years	30 Participants
Number of Participants With Adverse Events According to Demographic Characteristics Pediatric(< 19 years)	0 Participants
Number of Participants With Adverse Events According to Demographic Characteristics Geriatric(>= 65 years)	49 Participants
Number of Participants With Adverse Events According to Demographic Characteristics Classification: Outpatient	86 Participants

PRIMARY outcome

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).

Outcome measures

Outcome measures
Measure	Inlyta n=92 Participants 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.
Number of Participants With Adverse Events According to Other Baseline Characteristics Cell component of aRCC: Other	0 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Metastasis site: Liver	6 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Duration of aRCC: < 30 months	46 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Duration of aRCC: >= 30 months and < 60 months	22 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Duration of aRCC: >= 60 months	24 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Cell component of aRCC: Clear cell	92 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Metastasis: Yes	90 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Metastasis: No	2 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Metastasis site: Lung	67 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Metastasis site: Bone	25 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Metastasis site: Brain	9 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Metastasis site: Skin	2 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Metastasis site: Lymph nodes	19 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Metastasis site: Other	18 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Primary lesion surgery: Done	65 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Primary lesion surgery: Not done	27 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Medical history: Yes	85 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Medical history: No	7 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Renal impairment: Yes	8 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Renal impairment: No	84 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Hepatic impairment: Yes	4 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Hepatic impairment: No	88 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Allergic history: Yes	5 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Allergic history: No	87 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Prior chemotherapy: Yes	92 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Prior chemotherapy: No	0 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Prior immunotherapy: Yes	0 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Prior immunotherapy: No	92 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Prior radiation therapy: Yes	21 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Prior radiation therapy: No	69 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Concomitant medication: Yes	91 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Concomitant medication: No	1 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Duration of administration: < 90 days	20 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Duration of administration: >= 90 days and <180 days	23 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Duration of administration: >= 180 days	48 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Daily average dose: < 10 mg/day	32 Participants
Number of Participants With Adverse Events According to Other Baseline Characteristics Daily average dose: >= 10 mg/day	59 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Inlyta n=111 Participants 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.
Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis	92 Participants

PRIMARY outcome

Population: 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.

Outcome measures

Outcome measures
Measure	Inlyta n=62 Participants 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.
Number of Participants With AEs and ADRs - Special Participant Population Hepatic impairment - ADRs	3 Participants
Number of Participants With AEs and ADRs - Special Participant Population Geriatric - AEs	49 Participants
Number of Participants With AEs and ADRs - Special Participant Population Geriatric - ADRs	41 Participants
Number of Participants With AEs and ADRs - Special Participant Population Renal impairment - AEs	8 Participants
Number of Participants With AEs and ADRs - Special Participant Population Renal impairment - ADRs	6 Participants
Number of Participants With AEs and ADRs - Special Participant Population Hepatic impairment - AEs	4 Participants

PRIMARY outcome

Timeframe: From first dose of Inlyta up to first documented CR, PR, PD or SD, during observation period of the study of 9 years

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

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.

Outcome measures

Outcome measures
Measure	Inlyta n=111 Participants 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.
Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Complete response (CR)	4 Participants
Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Partial response (PR)	29 Participants
Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Progressive disease (PD)	15 Participants
Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Stable disease (SD)	51 Participants
Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Not done	12 Participants

PRIMARY outcome

Timeframe: From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years

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

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.

Outcome measures

Outcome measures
Measure	Inlyta n=111 Participants 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.
Number of Participants With Objective Response	33 Participants

PRIMARY outcome

Timeframe: From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years

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.

Outcome measures

Outcome measures
Measure	Inlyta n=33 Participants 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.
Number of Participants With Objective Response According to Demographic Characteristics Sex: Female	8 Participants
Number of Participants With Objective Response According to Demographic Characteristics Classification: Outpatient	33 Participants
Number of Participants With Objective Response According to Demographic Characteristics Classification: Inpatient	0 Participants
Number of Participants With Objective Response According to Demographic Characteristics Sex: Male	25 Participants
Number of Participants With Objective Response According to Demographic Characteristics Age: < 60 years	12 Participants
Number of Participants With Objective Response According to Demographic Characteristics Age: >= 60 years and < 70 years	13 Participants
Number of Participants With Objective Response According to Demographic Characteristics Age: >= 70 years	8 Participants
Number of Participants With Objective Response According to Demographic Characteristics Pediatric(< 19 years)	0 Participants
Number of Participants With Objective Response According to Demographic Characteristics Geriatric(>= 65 years)	17 Participants

PRIMARY outcome

Timeframe: From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years

Population: Efficacy analysis set included all participants who had been administered Inlyta at least once. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure. "Number Analyzed" refers to number of participants evaluable for the specified categories.

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.

Outcome measures

Outcome measures
Measure	Inlyta n=33 Participants 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.
Number of Participants With Objective Response According to Other Baseline Characteristics Cell component of aRCC: Clear cell	33 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Metastasis: No	1 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Metastasis site: Lung	26 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Metastasis site: Bone	5 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Metastasis site: Other	8 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Primary lesion surgery: Done	27 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Primary lesion surgery: Not done	6 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Medical history: No	6 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Hepatic impairment: Yes	1 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Hepatic impairment: No	32 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Allergic history: Yes	1 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Prior immunotherapy: No	33 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Prior radiation therapy: No	26 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Concomitant medication: No	0 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Duration of administration: < 90 days	3 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Medical history: Yes	27 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Duration of aRCC: < 30 months	16 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Duration of aRCC: >= 30 months and < 60 months	9 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Duration of aRCC: >= 60 months	8 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Cell component of aRCC: Other	0 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Metastasis: Yes	32 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Metastasis site: Liver	3 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Metastasis site: Brain	1 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Metastasis site: Skin	0 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Metastasis site: Lymph nodes	8 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Renal impairment: Yes	1 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Renal impairment: No	32 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Allergic history: No	32 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Prior chemotherapy: Yes	33 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Prior chemotherapy: No	0 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Prior immunotherapy: Yes	0 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Prior radiation therapy: Yes	6 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Concomitant medication: Yes	33 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Duration of administration: >= 90 days and <180 days	11 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Duration of administration: >= 180 days	19 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Daily average dose: < 10 mg/day	9 Participants
Number of Participants With Objective Response According to Other Baseline Characteristics Daily average dose: >= 10 mg/day	24 Participants

PRIMARY outcome

Timeframe: From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years

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

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.

Outcome measures

Outcome measures
Measure	Inlyta n=111 Participants 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.
Number of Participants With Objective Response - Multivariate Logistic Regression Analysis	33 Participants

PRIMARY outcome

Timeframe: From first dose of Inlyta up to first documented tumor progression or death, whichever occurred first, during observation period of the study of 9 years

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

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.

Outcome measures

Outcome measures
Measure	Inlyta n=111 Participants 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.
Progression Free Survival (PFS)	232.9 Days Standard Deviation 169.23

PRIMARY outcome

Timeframe: From first dose of Inlyta up to first documented disease progression or latest follow-up, during observation period of the study of 9 years

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

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.

Outcome measures

Outcome measures
Measure	Inlyta n=111 Participants 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.
Time to Progression (TTP)	232.9 Days Standard Deviation 169.23

Adverse Events

Inlyta

Serious events: 14 serious events

Other events: 92 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Inlyta n=111 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Diarrhoea	2.7% 3/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Asthenia	2.7% 3/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Death	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Pyrexia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Hepatobiliary disorders Cholecystitis acute	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Infections and infestations Cellulitis	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Metabolism and nutrition disorders Hyperkalaemia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Nervous system disorders Cerebral infarction	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.

Other adverse events

Other adverse events
Measure	Inlyta n=111 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Blood and lymphatic system disorders Thrombocytopenia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Cardiac disorders Angina unstable	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Cardiac disorders Palpitations	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Cardiac disorders Sinus bradycardia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Ear and labyrinth disorders Eustachian tube patulous	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Endocrine disorders Hypothyroidism	9.0% 10/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Abdominal pain	7.2% 8/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Abdominal pain upper	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Constipation	6.3% 7/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Diarrhoea	34.2% 38/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Duodenal ulcer	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Dyspepsia	4.5% 5/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Dysphagia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Nausea	6.3% 7/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Proctalgia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Proctitis	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Stomatitis	17.1% 19/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Toothache	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Gastrointestinal disorders Vomiting	4.5% 5/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Asthenia	9.0% 10/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Chest discomfort	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Chest pain	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Fatigue	9.0% 10/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Generalised oedema	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Mucosal inflammation	2.7% 3/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Oedema	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
General disorders Oedema peripheral	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Infections and infestations Ecthyma	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Infections and infestations Endometritis	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Infections and infestations Gingivitis	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Infections and infestations Herpes zoster	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Infections and infestations Oral candidiasis	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Infections and infestations Pneumonia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Infections and infestations Rhinitis	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Infections and infestations Urinary tract infection	2.7% 3/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Injury, poisoning and procedural complications Pelvic fracture	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Investigations Alanine aminotransferase increased	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Investigations Aspartate aminotransferase increased	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Investigations Blood pressure increased	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Investigations Liver function test increased	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Investigations Thyroid function test abnormal	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Investigations Weight decreased	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Investigations White blood cell count decreased	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Metabolism and nutrition disorders Decreased appetite	13.5% 15/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Metabolism and nutrition disorders Dyslipidaemia	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Metabolism and nutrition disorders Gout	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Metabolism and nutrition disorders Hyperglycaemia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Metabolism and nutrition disorders Hyperkalaemia	2.7% 3/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Metabolism and nutrition disorders Hypoalbuminaemia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Metabolism and nutrition disorders Hypophagia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Musculoskeletal and connective tissue disorders Back pain	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Musculoskeletal and connective tissue disorders Flank pain	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Musculoskeletal and connective tissue disorders Myalgia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Musculoskeletal and connective tissue disorders Pain in extremity	2.7% 3/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Musculoskeletal and connective tissue disorders Pathological fracture	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Nervous system disorders Cerebral infarction	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Nervous system disorders Diabetic neuropathy	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Nervous system disorders Dizziness	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Nervous system disorders Headache	3.6% 4/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Nervous system disorders Neuropathy peripheral	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Nervous system disorders Peripheral sensory neuropathy	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Nervous system disorders Tension headache	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Psychiatric disorders Depression	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Psychiatric disorders Insomnia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Renal and urinary disorders Chronic kidney disease	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Renal and urinary disorders Dysuria	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Renal and urinary disorders Haematuria	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Renal and urinary disorders Neurogenic bladder	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Renal and urinary disorders Nocturia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Renal and urinary disorders Proteinuria	3.6% 4/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Reproductive system and breast disorders Ejaculation failure	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Reproductive system and breast disorders Perineal pain	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Respiratory, thoracic and mediastinal disorders Cough	4.5% 5/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.4% 6/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.8% 2/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Respiratory, thoracic and mediastinal disorders Hiccups	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Acne	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Alopecia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Blister	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Erythema	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Hand dermatitis	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	11.7% 13/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Palmoplantar keratoderma	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Palmoplantar pustulosis	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Pruritus	2.7% 3/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Rash	2.7% 3/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Sebaceous hyperplasia	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Skin and subcutaneous tissue disorders Urticaria	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Vascular disorders Deep vein thrombosis	0.90% 1/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.
Vascular disorders Hypertension	20.7% 23/111 • From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years) 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.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER