Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC

Time frame: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study.

Time frame: At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study.

Time frame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

In this outcome measure, data for participants with their best response as complete response (CR) and partial response (PR), stable disease (SD) or progressive-disease (PD) to the first line treatment with TKI, was compared between long responders and refractory participants. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: CR = disappearance of all target lesions. PR = greater than equal to (\>=) 30% decrease in sum of target lesions taking as reference baseline sum diameters. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of \>=1 new lesions. SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters during treatment.

Time frame: First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

In this outcome measure, data for participants with different metastatic sites as lymph nodes, central nervous system (CNS), hepatic, pulmonary, bone and another site of metastasis at diagnosis of advance or mRCC before axitinib treatment initiation, was compared between long responders and refractory participants.

Time frame: At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study.

In this outcome measure, data for participants who had renal cells with different type of histology as 100% clear cells, 100% non-clear cells, majority component of clear cells and majority component of non-clear cells was compared between long responders and refractory participants.

Time frame: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

Duration of first line treatment with TKI was stratified into 0-3 months, 3-6 months, 6-9 months, 9-12 months and \>12 months and compared between long responders and refractory participants.

Time frame: First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, \>=2: at initiation of axitinib), was compared between long responders and refractory participants.

Time frame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, \>=2: before first line treatment initiation), was compared between long responders and refractory participants.

Time frame: Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, \>=2: on axitinib discontinuation), was compared between long responders and refractory participants.

Time frame: On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

IMDC risk group stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 poor prognostic factors. Poor-risk group: participants had 3 to 6 poor prognostic factors. Poor prognostic factors included KPS score of \<80 at the initiation of treatment, time from diagnosis to metastasis treatment of \<12 months, anemia, hypercalcemia (corrected calcium \>10 mg/dL), neutrophilia and thrombocythemia. In this outcome measure, IMDC risk group (favorable, intermediate, poor: at initiation of axitinib) was compared between long responders and refractory participants.

Time frame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

IMDC risk group stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 poor prognostic factors. Poor-risk group: participants had 3 to 6 poor prognostic factors. Poor prognostic factors included KPS score of \<80 at the initiation of treatment, time from diagnosis to metastasis treatment of \<12 months, anemia, hypercalcemia (corrected calcium \>10 mg/dL), neutrophilia and thrombocythemia. In this outcome measure, IMDC risk group (favorable, intermediate, poor: on discontinuation of axitinib) was compared between long responders and refractory participants.

Time frame: On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

In this outcome measure, data for different laboratory parameters at initiation of first line treatment: LDH level \>1.5\*ULN, haemoglobin (Hgb) levels \<=LLN, corrected Ca levels \>10 mg/dL, neutrophil levels \>ULN, platelet levels \>ULN and neutrophil-to-lymphocyte ratio of \<=3 was compared between long responders and refractory participants.

Time frame: At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study.

MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a KPS of \<80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum LDH \>1.5\*ULN, corrected serum calcium level \>10.0 mg/dL and hemoglobin \< LLN.

Time frame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a Karnofsky performance status (KPS) of less than (\<) 80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum lactate dehydrogenase (LDH) \>1.5\*upper limit of normal (ULN), corrected serum calcium level \>10.0 milligram per deciliter (mg/dL) and hemoglobin \< lower limit of normal (LLN).

Time frame: Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a KPS of \<80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum LDH \>1.5\*ULN, corrected serum calcium level \>10.0 mg/dL and hemoglobin \< LLN.

Time frame: On discontinuation of axitinib treatment, within axitinib therapy during treatment of maximum 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

Nephrectomy is a surgical removal of kidney. Data for participants was categorized as yes and no to depict their nephrectomy status before axitinib treatment initiation and comparison was done between long responders and refractory participants.

Time frame: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study.

In this outcome measure, data for smoking habit of participants was compared between long responders and refractory participants.

Time frame: At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

CBR was defined as the frequency of participants with CR, PR or SD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = \>= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of \>=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment.

Time frame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. This outcome measure as per protocol was intended to be analyzed only in long responders group.

Duration of treatment with axitinib was the time from date of start of axitinib treatment to date of end of axitinib treatment or of latest follow-up if not suspended.

Time frame: Day 1 of axitinib treatment to end of treatment or date of latest follow-up if not suspended for maximum axitinib therapy duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. As per protocol, no comparison was planned between long responders and refractory participants.

Time frame: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. Here, Overall Number of Participants signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.

Time frame: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. Here, Overall Number of Participants signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.

Time frame: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. Here, Overall Number of Participants signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both SAEs and non-SAEs.

Time frame: For first line treatment: maximum of 6.6 years approximately; for axitinib treatment: maximum of 5.4 years approximately; for post-axitinib subsequent treatments: maximum of 2.9 years approximately (data collected and observed retrospectively for 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. As per protocol, no comparison was planned between long responders and refractory participants.

In this outcome measure, data for number of participants with best response to axitinib as second line of treatment and subsequent treatment was collected. Best response is CR and PR, SD or PD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = \>= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of \>=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment. Subsequent treatment referred to further treatment after second line of treatment.

Time frame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. This outcome measure as per protocol was intended to be analyzed only in long responders group.

Best response is CR and PR, SD or PD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = \>= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of \>=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment.

Time frame: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. Here, Overall Number of Participants signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.

In this outcome measure, participants who stopped subsequent treatments after axitinib discontinuation due to any reasons like PD, toxicity and others are reported.

Time frame: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. This outcome measure as per protocol was intended to be analyzed only in long responders group. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

ORR was defined as the number of participants with CR or PR. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = \>= 30% decrease in sum of target lesions taking as reference baseline sum diameters.

Time frame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. This outcome measure as per protocol was intended to be analyzed only in long responders group.

OS was defined as the time from the date of start of axitinib treatment to the date of death due to any cause. If there was no death, the case was censored as OS at latest follow-up.

Time frame: Day 1 of axitinib dose to death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.

OS was defined as the time from the date of randomization to treatment up to the date of death due to any cause.

Time frame: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. This outcome measure as per protocol was intended to be analyzed only in long responders group. Here, Overall Number of Participants signifies participants evaluable for this outcome measure.

OS was defined as the time from the date of start of second line of treatment and subsequent treatment till the date of death due to any cause. If there was no death, the case was censored as OS at latest follow-up.

Time frame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to death due to any cause/date of latest follow-up if censored upto max. of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.

Percentage of participants whose axitinib dose was reduced 5 mg dose at least 1 time in 12 hours (twice daily) are reported in this outcome measure.

Time frame: For maximum axitinib treatment duration of 5.4 years, approximately (data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. Here, Overall Number of Participants signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.

Percentage of participants whose axitinib dose was titrated and increased to more than 5mg dose at least 1 time in 12 hours (twice daily), are reported in this outcome measure.

Time frame: For maximum axitinib treatment duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)

Population: FAS population was analyzed. Here, Overall Number of Participants signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.

PFS was defined as the time from the start of axitinib as second line of treatment and subsequent treatment to disease progression or death by any cause. If there was no progression or death, the case was censored as PFS at date of latest follow-up. As per RECIST 1.1, PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of \>=1 new lesions.

Time frame: From first dose of axitinib as second line and from first dose of axitinib as subsequent lines to PD/death by any cause/date of latest follow-up if censored up to a max. axitinib therapy of 5.4 yrs. approx. (data collected, observed retrospectively 1 yr.)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.

PFS was defined as the time from the start of axitinib treatment to disease progression or death by any cause. If there was no progression or death, the case was censored as PFS at date of latest follow-up. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of \>=1 new lesions.

Time frame: Day 1 of axitinib dose to disease progression or death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.

TTP was defined as the time from the start of second line of treatment and subsequent treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of \>=1 new lesions.

Time frame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to PD/date of latest follow-up if censored up to max. treatment duration of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.

TTP was defined as the time from the start of axitinib treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. As per RECIST 1.1, PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of \>=1 new lesions.

Time frame: Day 1 of axitinib dose to disease progression or date of latest follow-up in case of censored up to a maximum (max.)axitinib therapy duration of 5.4 years(yrs.)approximately(approx.)(from the data collected, observed retrospectively during 1 year [yr.])

Population: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.