Advanced Renal Cell Carcinoma
Conditions
Keywords
Korean PMS of Axitinib, Metastatic RCC ; 2nd line only
Brief summary
The objective of this study is to monitor the usage of INLYTA® in real practice, including the adverse events associated with INLYTA®.
Detailed description
Investigators can choose any patient who is within the scope of I/E criteria
Interventions
DRUGAxitinib
based on Axitinib approval
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed as advanced RCC after failure of one prior systemic therapy.
Exclusion criteria
* Any patient who does not agree that Pfizer or companies working on behalf of Pfizer can use his/her information. * Patients with hypersensitivity to axitinib or to any other component of INLYTA® . * Patients under 18. * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | 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 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. |
| Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | 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 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. |
| Duration of Adverse Events | 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) | — |
| Number of Participants With Adverse Events by Their Severity | 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 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. |
| Number of Participants With Adverse Events by Their Outcome | 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 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. |
| Number of Participants With Adverse Events by Their Seriousness Criteria | 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 was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. |
| Number of Participants With Adverse Events by Their Causality to Inlyta | 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 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. |
| Number of Participants With Adverse Events by Their Other Causality | 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 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. |
| Number of Participants With Adverse Events by Their Action Taken With Study Drug | 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 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. |
| Number of Participants With Adverse Events According to Demographic Characteristics | 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 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. |
| Number of Participants With Adverse Events According to Other Baseline Characteristics | 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 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). |
| Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis | 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 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 and ADRs - Special Participant Population | 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 was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta. |
| Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | From first dose of Inlyta up to first documented CR, PR, PD or SD, during observation period of the study of 9 years | 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. |
| Number of Participants With Objective Response | From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years | 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. |
| Number of Participants With Objective Response According to Demographic Characteristics | 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. |
| Number of Participants With Objective Response According to Other Baseline Characteristics | 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. 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. |
| Number of Participants With Objective Response - Multivariate Logistic Regression Analysis | 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 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. |
| Progression Free Survival (PFS) | 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 | 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. |
| Time to Progression (TTP) | From first dose of Inlyta up to first documented disease progression or latest follow-up, during observation period of the study of 9 years | 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. |
Countries
South Korea
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Inlyta 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. | 111 |
| Total | 111 |
Baseline characteristics
| Characteristic | Inlyta | — |
|---|---|---|
| Age, Continuous | 64.92 Years STANDARD_DEVIATION 10.44 | — |
| Duration of Advanced Renal Cell Carcinoma (aRCC) | 46.84 Months STANDARD_DEVIATION 55.21 | — |
| Number of Participants According to Sites of Metastasis Bone | 31 Participants | — |
| Number of Participants According to Sites of Metastasis Brain | 9 Participants | — |
| Number of Participants According to Sites of Metastasis Liver | 7 Participants | — |
| Number of Participants According to Sites of Metastasis Lung | 84 Participants | — |
| Number of Participants According to Sites of Metastasis Lymph nodes | 19 Participants | — |
| Number of Participants According to Sites of Metastasis None | 2 Participants | — |
| Number of Participants According to Sites of Metastasis Other | 23 Participants | — |
| Number of Participants According to Sites of Metastasis Skin | 2 Participants | — |
| Number of Participants Categorized According to Cell Component of aRCC Clear cell | 110 Participants | — |
| Number of Participants Categorized According to Cell Component of aRCC Other | 1 Participants | — |
| Number of Participants who Received Chemotherapy Prior to Inlyta | 111 Participants | — |
| Number of Participants who Received Concomitant Medication | 109 Participants | — |
| Number of Participants who Received Immunotherapy Prior to Inlyta | 1 Participants | — |
| Number of Participants who Received Radiation Therapy Prior to Inlyta | 26 Participants | — |
| Number of Participants who Underwent Primary Lesion Surgery | 77 Participants | — |
| Number of Participants With Allergic History | 6 Participants | — |
| Number of Participants With Hepatic Impairment | 4 Participants | — |
| Number of Participants With Medical History | 101 Participants | — |
| Number of Participants With Renal Impairment | 9 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 90 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 111 |
| other Total, other adverse events | 92 / 111 |
| serious Total, serious adverse events | 14 / 111 |
Outcome results
Primary
Duration of Adverse Events
Time frame: 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. Here, Overall Number of Participants Analyzed signifies number of participants without missing date or month of AE onset.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inlyta | Duration of Adverse Events | 28 Days |
Primary
Number of Participants With Adverse Events According to Demographic Characteristics
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.
Time frame: 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. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Adverse Events According to Demographic Characteristics | Sex: Male | 71 Participants |
| Inlyta | Number of Participants With Adverse Events According to Demographic Characteristics | Sex: Female | 21 Participants |
| Inlyta | Number of Participants With Adverse Events According to Demographic Characteristics | Age: < 60 years | 28 Participants |
| Inlyta | Number of Participants With Adverse Events According to Demographic Characteristics | Age: >= 60 years and < 70 years | 34 Participants |
| Inlyta | Number of Participants With Adverse Events According to Demographic Characteristics | Age: >= 70 years | 30 Participants |
| Inlyta | Number of Participants With Adverse Events According to Demographic Characteristics | Pediatric(< 19 years) | 0 Participants |
| Inlyta | Number of Participants With Adverse Events According to Demographic Characteristics | Geriatric(>= 65 years) | 49 Participants |
| Inlyta | Number of Participants With Adverse Events According to Demographic Characteristics | Classification: Outpatient | 86 Participants |
| Inlyta | Number of Participants With Adverse Events According to Demographic Characteristics | Classification: Inpatient | 6 Participants |
Primary
Number of Participants With Adverse Events According to Other Baseline Characteristics
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).
Time frame: 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. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. Number Analyzed refers to number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of aRCC: < 30 months | 46 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of aRCC: >= 30 months and < 60 months | 22 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of aRCC: >= 60 months | 24 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Cell component of aRCC: Clear cell | 92 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Cell component of aRCC: Other | 0 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Metastasis: Yes | 90 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Metastasis: No | 2 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Metastasis site: Liver | 6 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Metastasis site: Lung | 67 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Metastasis site: Bone | 25 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Metastasis site: Brain | 9 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Metastasis site: Skin | 2 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Metastasis site: Lymph nodes | 19 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Metastasis site: Other | 18 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Primary lesion surgery: Done | 65 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Primary lesion surgery: Not done | 27 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Medical history: Yes | 85 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Medical history: No | 7 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Renal impairment: Yes | 8 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Renal impairment: No | 84 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Hepatic impairment: Yes | 4 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Hepatic impairment: No | 88 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Allergic history: Yes | 5 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Allergic history: No | 87 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Prior chemotherapy: Yes | 92 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Prior chemotherapy: No | 0 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Prior immunotherapy: Yes | 0 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Prior immunotherapy: No | 92 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Prior radiation therapy: Yes | 21 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Prior radiation therapy: No | 69 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Concomitant medication: Yes | 91 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Concomitant medication: No | 1 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of administration: < 90 days | 20 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of administration: >= 90 days and <180 days | 23 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of administration: >= 180 days | 48 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Daily average dose: < 10 mg/day | 32 Participants |
| Inlyta | Number of Participants With Adverse Events According to Other Baseline Characteristics | Daily average dose: >= 10 mg/day | 59 Participants |
Primary
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | AEs | 92 Participants |
| Inlyta | Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | ADRs | 79 Participants |
| Inlyta | Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | SAEs | 14 Participants |
| Inlyta | 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
Number of Participants With Adverse Events by Their Action Taken With Study Drug
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.
Time frame: 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. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Adverse Events by Their Action Taken With Study Drug | Discontinuation | 19 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Action Taken With Study Drug | Dosage reduced | 34 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Action Taken With Study Drug | No change | 75 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Action Taken With Study Drug | Unknown | 1 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Action Taken With Study Drug | Not applicable | 8 Participants |
Primary
Number of Participants With Adverse Events by Their Causality to Inlyta
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.
Time frame: 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. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Adverse Events by Their Causality to Inlyta | Certain | 1 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Causality to Inlyta | Probable/likely | 7 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Causality to Inlyta | Possible | 77 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Causality to Inlyta | Unlikely | 35 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Causality to Inlyta | Conditional/unclassified | 2 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Causality to Inlyta | Unaccessible/unclassifiable | 1 Participants |
Primary
Number of Participants With Adverse Events by Their Other Causality
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.
Time frame: 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. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Adverse Events by Their Other Causality | Disease under the study | 4 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Other Causality | Other disease | 10 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Other Causality | Concomitant treatment drug or non-drug | 2 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Other Causality | Others | 26 Participants |
Primary
Number of Participants With Adverse Events by Their 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.
Time frame: 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. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Adverse Events by Their Outcome | Recovered | 61 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Outcome | Recovered with sequelae | 1 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Outcome | Recovering | 38 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Outcome | Not recovered | 23 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Outcome | Unknown | 12 Participants |
Primary
Number of Participants With Adverse Events by Their Seriousness Criteria
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event.
Time frame: 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. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Adverse Events by Their Seriousness Criteria | Results in death | 2 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Seriousness Criteria | Is life-threatening | 0 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Seriousness Criteria | Requires inpatient hospitalization or prolongation of hospitalization | 14 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Seriousness Criteria | Results in persistent or significant disability/incapacity | 0 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Seriousness Criteria | Results in congenital anomaly/birth defect | 0 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Seriousness Criteria | Other important medical event | 2 Participants |
Primary
Number of Participants With Adverse Events by Their Severity
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.
Time frame: 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. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Adverse Events by Their Severity | Grade 1 | 68 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Severity | Grade 2 | 54 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Severity | Grade 3 | 26 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Severity | Grade 4 | 1 Participants |
| Inlyta | Number of Participants With Adverse Events by Their Severity | Grade 5 | 2 Participants |
Primary
Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inlyta | Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis | 92 Participants |
p-value: 0.124495% CI: [0.97, 1.24]Regression, Logistic
Primary
Number of Participants With AEs and ADRs - Special Participant Population
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Inlyta in a participant who received Inlyta.
Time frame: 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: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With AEs and ADRs - Special Participant Population | Geriatric - AEs | 49 Participants |
| Inlyta | Number of Participants With AEs and ADRs - Special Participant Population | Geriatric - ADRs | 41 Participants |
| Inlyta | Number of Participants With AEs and ADRs - Special Participant Population | Renal impairment - AEs | 8 Participants |
| Inlyta | Number of Participants With AEs and ADRs - Special Participant Population | Renal impairment - ADRs | 6 Participants |
| Inlyta | Number of Participants With AEs and ADRs - Special Participant Population | Hepatic impairment - AEs | 4 Participants |
| Inlyta | Number of Participants With AEs and ADRs - Special Participant Population | Hepatic impairment - ADRs | 3 Participants |
Primary
Number of Participants With Objective Response
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inlyta | Number of Participants With Objective Response | 33 Participants |
Primary
Number of Participants With Objective Response According to Demographic Characteristics
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.
Time frame: 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 evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Objective Response According to Demographic Characteristics | Sex: Male | 25 Participants |
| Inlyta | Number of Participants With Objective Response According to Demographic Characteristics | Sex: Female | 8 Participants |
| Inlyta | Number of Participants With Objective Response According to Demographic Characteristics | Age: < 60 years | 12 Participants |
| Inlyta | Number of Participants With Objective Response According to Demographic Characteristics | Age: >= 60 years and < 70 years | 13 Participants |
| Inlyta | Number of Participants With Objective Response According to Demographic Characteristics | Age: >= 70 years | 8 Participants |
| Inlyta | Number of Participants With Objective Response According to Demographic Characteristics | Pediatric(< 19 years) | 0 Participants |
| Inlyta | Number of Participants With Objective Response According to Demographic Characteristics | Geriatric(>= 65 years) | 17 Participants |
| Inlyta | Number of Participants With Objective Response According to Demographic Characteristics | Classification: Outpatient | 33 Participants |
| Inlyta | Number of Participants With Objective Response According to Demographic Characteristics | Classification: Inpatient | 0 Participants |
Primary
Number of Participants With Objective Response According to Other Baseline Characteristics
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Duration of aRCC: < 30 months | 16 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Duration of aRCC: >= 30 months and < 60 months | 9 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Duration of aRCC: >= 60 months | 8 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Cell component of aRCC: Clear cell | 33 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Cell component of aRCC: Other | 0 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Metastasis: Yes | 32 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Metastasis: No | 1 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Metastasis site: Liver | 3 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Metastasis site: Lung | 26 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Metastasis site: Bone | 5 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Metastasis site: Brain | 1 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Metastasis site: Skin | 0 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Metastasis site: Lymph nodes | 8 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Metastasis site: Other | 8 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Primary lesion surgery: Done | 27 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Primary lesion surgery: Not done | 6 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Medical history: Yes | 27 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Medical history: No | 6 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Renal impairment: Yes | 1 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Renal impairment: No | 32 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Hepatic impairment: Yes | 1 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Hepatic impairment: No | 32 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Allergic history: Yes | 1 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Allergic history: No | 32 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Prior chemotherapy: Yes | 33 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Prior chemotherapy: No | 0 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Prior immunotherapy: Yes | 0 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Prior immunotherapy: No | 33 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Prior radiation therapy: Yes | 6 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Prior radiation therapy: No | 26 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Concomitant medication: Yes | 33 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Concomitant medication: No | 0 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Duration of administration: < 90 days | 3 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Duration of administration: >= 90 days and <180 days | 11 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Duration of administration: >= 180 days | 19 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Daily average dose: < 10 mg/day | 9 Participants |
| Inlyta | Number of Participants With Objective Response According to Other Baseline Characteristics | Daily average dose: >= 10 mg/day | 24 Participants |
Primary
Number of Participants With Objective Response - Multivariate Logistic Regression Analysis
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inlyta | Number of Participants With Objective Response - Multivariate Logistic Regression Analysis | 33 Participants |
p-value: 0.010995% CI: [1.02, 1.2]Regression, Logistic
Primary
Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Complete response (CR) | 4 Participants |
| Inlyta | Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Partial response (PR) | 29 Participants |
| Inlyta | Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Progressive disease (PD) | 15 Participants |
| Inlyta | Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Stable disease (SD) | 51 Participants |
| Inlyta | Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Not done | 12 Participants |
Primary
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inlyta | Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | Unexpected AEs | 34 Participants |
| Inlyta | Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | Unexpected ADRs | 16 Participants |
| Inlyta | Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | Unexpected SAEs | 4 Participants |
| Inlyta | Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | Unexpected SADRs | 0 Participants |
Primary
Progression Free Survival (PFS)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inlyta | Progression Free Survival (PFS) | 232.9 Days | Standard Deviation 169.23 |
Primary
Time to Progression (TTP)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inlyta | Time to Progression (TTP) | 232.9 Days | Standard Deviation 169.23 |