Trial Outcomes & Findings for REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (NCT NCT03916458)

Last Updated: 2021-12-13

Results Overview

Time to complete remission of lesions was calculated as the difference between treatment start date and complete response (CR) confirmation date. As per response evaluation criteria in solid tumors (RECIST) version (v) 1.1, CR = disappearance of all known target and all non-target lesions and the absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 millimeter (mm). CR was confirmed with 2 consecutive computed tomography (CT) scans performed with at least 4 weeks between them during the follow-up of participants. Confirmation from the oncologist and radiologist was required at each site.

Recruitment status

COMPLETED

Target enrollment

62 participants

Primary outcome timeframe

From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Results posted on

2021-12-13

Participant Flow

Participants aged above or equal to 18 years, with metastatic renal cell carcinoma (mRCC), and who according to the usual evaluation criteria in daily clinical practice obtained a complete response with sunitinib as first-line treatment between 2007 and 30 October 2018, either alone or with subsequent local treatment, were observed retrospectively in this study for a period of 10 months approximately.

Participant milestones

Participant milestones
Measure	Sunitinib Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 milligrams (mg) capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Overall Study STARTED	62
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib n=62 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Age, Continuous	58.3 Years STANDARD_DEVIATION 11.8 • n=62 Participants
Number of Participants With Comorbidities Cardiovascular Disease	29 Participants n=62 Participants
Number of Participants With Comorbidities Liver Disorders	2 Participants n=62 Participants
Number of Participants With Comorbidities Renal Failure	5 Participants n=62 Participants
Number of Participants With Comorbidities Autoimmune Disease	0 Participants n=62 Participants
Number of Participants With Comorbidities Chronic Dermatological Disease	1 Participants n=62 Participants
Number of Participants With Comorbidities Obesity	11 Participants n=62 Participants
Number of Participants With Comorbidities Bowel Disease	1 Participants n=62 Participants
Number of Participants With Comorbidities Other Disease	28 Participants n=62 Participants
Participants With Number of Metastatic Sites 1	25 Participants n=62 Participants
Participants With Number of Metastatic Sites 2	13 Participants n=62 Participants
Participants With Number of Metastatic Sites 3	7 Participants n=62 Participants
Participants With Number of Metastatic Sites 4	2 Participants n=62 Participants
Participants With Number of Metastatic Sites 5	4 Participants n=62 Participants
Participants With Number of Metastatic Sites Greater than (>) 5	3 Participants n=62 Participants
Participants With Number of Metastatic Sites Data not available	8 Participants n=62 Participants
Number of Participants According to Type of Metastatic Sites Lung	42 Participants n=62 Participants
Number of Participants According to Type of Metastatic Sites Liver	6 Participants n=62 Participants
Number of Participants According to Type of Metastatic Sites Brain	2 Participants n=62 Participants
Number of Participants According to Type of Metastatic Sites Pancreas	5 Participants n=62 Participants
Number of Participants According to Type of Metastatic Sites Contralateral Kidney	2 Participants n=62 Participants
Number of Participants According to Type of Metastatic Sites Nodes	23 Participants n=62 Participants
Number of Participants According to Type of Metastatic Sites Bone	6 Participants n=62 Participants
Number of Participants According to Type of Metastatic Sites Muscles, Soft tissues, Vessels and Peritoneum	8 Participants n=62 Participants
Number of Participants According to Type of Metastatic Sites Endocrine Glands	6 Participants n=62 Participants
Number of Participants Classified According to Tumor Fuhrman Grade I	3 Participants n=62 Participants
Number of Participants Classified According to Tumor Fuhrman Grade II	23 Participants n=62 Participants
Number of Participants Classified According to Tumor Fuhrman Grade III	18 Participants n=62 Participants
Number of Participants Classified According to Tumor Fuhrman Grade IV	9 Participants n=62 Participants
Number of Participants Classified According to Tumor Fuhrman Grade II and IV	1 Participants n=62 Participants
Number of Participants Classified According to Tumor Fuhrman Grade Data not available	8 Participants n=62 Participants
Histological Type of Tumor Clear Cell	49 Participants n=62 Participants
Histological Type of Tumor Non-clear Cell	5 Participants n=62 Participants
Histological Type of Tumor Sarcomatoid	7 Participants n=62 Participants
Histological Type of Tumor Data not available	1 Participants n=62 Participants
Pre-treatment Necrosis Percentage	18.2 Percentage of Necrosis STANDARD_DEVIATION 30.4 • n=13 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Number of Participants With Previous Nephrectomy Status Yes	56 Participants n=62 Participants
Number of Participants With Previous Nephrectomy Status No	6 Participants n=62 Participants
Time Interval From Nephrectomy to Initiation of Sunitinib Treatment	15.3 Months n=56 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Number of Participants Classified According to Motzer Prognostic Criteria Favorable	11 Participants n=55 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Number of Participants Classified According to Motzer Prognostic Criteria Intermediate	42 Participants n=55 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Number of Participants Classified According to Motzer Prognostic Criteria Poor	2 Participants n=55 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0	38 Participants n=62 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 1	22 Participants n=62 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 2	1 Participants n=62 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Data not available	1 Participants n=62 Participants
Blood Hemoglobin Level	14.0 Gram per deciliter STANDARD_DEVIATION 3.1 • n=60 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Corrected Blood Calcium Level	9.4 Milligram per deciliter STANDARD_DEVIATION 0.9 • n=49 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Blood Lactate Dehydrogenase (LDH) Level	262.6 Units per liter STANDARD_DEVIATION 122.7 • n=51 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Platelets Level and Neutrophils Level Platelets	260.0 10^9 cells per liter STANDARD_DEVIATION 99.6 • n=60 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Platelets Level and Neutrophils Level Neutrophils	4.3 10^9 cells per liter STANDARD_DEVIATION 1.6 • n=58 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Number of Participants Classified According to Heng Prognostic Criteria Favorable	13 Participants n=57 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Number of Participants Classified According to Heng Prognostic Criteria Intermediate	40 Participants n=57 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.
Number of Participants Classified According to Heng Prognostic Criteria Poor	4 Participants n=57 Participants • Here, number analyzed signifies participants evaluable for this baseline measure.

PRIMARY outcome

Timeframe: From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. This outcome measure was evaluated in participants who achieved CR at respective CT scans.

Outcome measures

Outcome measures
Measure	Sunitinib n=62 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Time to Complete Remission of Lesions CR at 1st CT Scan	10.9 Months Interval 2.4 to 63.2
Time to Complete Remission of Lesions CR at 2nd CT Scan	15.7 Months Interval 5.6 to 67.2

PRIMARY outcome

Timeframe: From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

DOR was defined as the time from date on which the CR was identified until tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Sunitinib n=62 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Duration of Complete Remission (DOR) DOR, 1st CT Scan	64.1 Months Interval 6.3 to 145.2
Duration of Complete Remission (DOR) DOR, 2nd CT Scan	62.2 Months Interval 5.3 to 142.5

PRIMARY outcome

Timeframe: From CR confirmation date until progression/death or change of treatment due to unacceptable toxicity/last follow-up date, up to maximum of approximately 13 years (data collected, observed retrospectively for approximately 10 months)

PFS was calculated as the time from the date of CR confirmation (2nd CT scan) until the date of progression/death or change of treatment for unacceptable toxicity or censored on the date of the last follow-up. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Sunitinib n=62 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Progression Free Survival (PFS)	NA Months Median and full range could not be estimated because there were insufficient number of participants with event.

OTHER_PRE_SPECIFIED outcome

Timeframe: From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of \<80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease \<1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0 (dead) to 100 (normal, no complaint). High KPS score= participant better able to carry out daily activities.

Outcome measures

Outcome measures
Measure	Sunitinib n=57 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis Intermediate	11.7 Month Interval 2.4 to 63.2
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis Poor	6.1 Month Interval 2.8 to 13.5
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis Favorable	9.3 Month Interval 2.6 to 31.8

OTHER_PRE_SPECIFIED outcome

Timeframe: From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of \<80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease \<1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0(dead) to 100(normal, no complaint). High KPS score=participant better able to carry out daily activities.

Outcome measures

Outcome measures
Measure	Sunitinib n=56 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis at Least 2 Consecutive CT Scans Favorable	14.8 Months Interval 7.4 to 37.0
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis at Least 2 Consecutive CT Scans Intermediate	15.5 Months Interval 5.6 to 67.2
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis at Least 2 Consecutive CT Scans Poor	10.7 Months Interval 5.8 to 17.5

OTHER_PRE_SPECIFIED outcome

Timeframe: From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Time to achieve CR according to previous nephrectomy status were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site.

Outcome measures

Outcome measures
Measure	Sunitinib n=62 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Time to Achieve CR in Participants Classified According to Previous Nephrectomy Status Previous Nephrectomy: Yes	10.9 Months Interval 2.4 to 47.2
Time to Achieve CR in Participants Classified According to Previous Nephrectomy Status Previous Nephrectomy: No	16.6 Months Interval 6.8 to 63.2

OTHER_PRE_SPECIFIED outcome

Timeframe: From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Time to achieve CR according to type of histology as clear cell, non-clear cell and sarcomatoid were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site.

Outcome measures

Outcome measures
Measure	Sunitinib n=61 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Time to Achieve CR in Participants Classified According to Histology Type Clear cell	11.0 Months Interval 2.4 to 63.2
Time to Achieve CR in Participants Classified According to Histology Type Non-clear cell	8.3 Months Interval 2.6 to 18.3
Time to Achieve CR in Participants Classified According to Histology Type Sarcomatoid	9.9 Months Interval 2.8 to 47.2

OTHER_PRE_SPECIFIED outcome

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here, "number analyzed" signifies number of participants evaluable for specified rows.

Duration of response was defined as the time from date on which the CR was identified until the date of the CT scan conforming tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Sunitinib n=62 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Duration of Response Based on Type of Treatment Received Sunitinib Monotherapy	69.8 Months Interval 12.5 to 145.2
Duration of Response Based on Type of Treatment Received Sunitinib + subsequent local treatment	58.4 Months Interval 6.3 to 110.1

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Outcome measures

Outcome measures
Measure	Sunitinib n=62 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Number of Participants With Dose Interruption	47 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Local treatments were the following: traditional surgery, radiotherapy, or stereotactic body radiation therapy (SBRT), to achieve the total macroscopic disappearance of the disease along with CR, according to the opinion of the physician responsible for the participant.

Outcome measures

Outcome measures
Measure	Sunitinib n=62 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Number of Participants Who Received Subsequent Local Treatment	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Number of participants who discontinued sunitinib treatment due to toxicity were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Sunitinib n=34 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Number of Participants Who Discontinued Sunitinib Treatment Due to Toxicity	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Number of participants with Grade 3 or higher toxicity as per common terminology criteria for adverse events (CTCAE) version 4 were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death.

Outcome measures

Outcome measures
Measure	Sunitinib n=51 Participants Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Number of Participants With Grade 3 or Higher Toxicity to Sunitinib	28 Participants

Adverse Events

Sunitinib

Serious events: 9 serious events

Other events: 51 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib n=62 participants at risk Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Endocrine disorders Hypothyroidism	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
General disorders Asthenia	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
General disorders Mucosal inflammation	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Infections and infestations Bronchitis	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Infections and infestations Salmonelosis	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Renal and urinary disorders Acute kidney injury	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Rash	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Vascular disorders Hypertension	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Vascular disorders Hypotension	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.

Other adverse events

Other adverse events
Measure	Sunitinib n=62 participants at risk Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
Blood and lymphatic system disorders Anaemia	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Blood and lymphatic system disorders Neutropenia	12.9% 8/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Blood and lymphatic system disorders Pancytopenia	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Blood and lymphatic system disorders Thrombocytopenia	4.8% 3/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Cardiac disorders Cardiotoxicity	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Endocrine disorders Hyperthyroidism	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Endocrine disorders Hypothyroidism	16.1% 10/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Eye disorders Eyelid oedema	9.7% 6/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Gastrointestinal disorders Abdominal pain	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Gastrointestinal disorders Constipation	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Gastrointestinal disorders Diarrhoea	35.5% 22/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Gastrointestinal disorders Dyspepsia	6.5% 4/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Gastrointestinal disorders Nausea	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Gastrointestinal disorders Odynophagia	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Gastrointestinal disorders Stomatitis	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Gastrointestinal disorders Vomiting	4.8% 3/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Gastrointestinal disorders Gastrointestinal toxicity NOS	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
General disorders Asthenia	48.4% 30/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
General disorders Mucosal inflammation	33.9% 21/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
General disorders Oedema	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
General disorders Oedema peripheral	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Hepatobiliary disorders Cholecystitis	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Hepatobiliary disorders Hyperbilirubinaemia	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Infections and infestations Conjunctivitis	4.8% 3/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Infections and infestations Upper respiratory tract infection	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Infections and infestations Skin bacterial infection	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Investigations Ejection fraction decreased	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Investigations Transaminases increased	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Metabolism and nutrition disorders Decreased appetite	6.5% 4/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Metabolism and nutrition disorders Fluid retention	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Metabolism and nutrition disorders Hypercholesterolaemia	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Metabolism and nutrition disorders Hyperlipidaemia	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Metabolism and nutrition disorders Hyertriglyceridaemia	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Nervous system disorders Dysgeusia	14.5% 9/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Nervous system disorders Headache	4.8% 3/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Nervous system disorders Syncope	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Renal and urinary disorders Urinary incontinence	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Renal and urinary disorders Nephrotic syndrome	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Renal and urinary disorders Proteinuria	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Renal and urinary disorders Renal failure	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Reproductive system and breast disorders Vaginal haemorrhage	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.8% 3/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Albinism	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Alopecia	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Dermatitis	3.2% 2/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Hair colour changes	4.8% 3/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Nail pigmentation	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Onycholysis	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	40.3% 25/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Rash	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Skin discolouration	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Skin reaction	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Skin toxicity	6.5% 4/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Skin ulcer	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Xeroderma	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Skin and subcutaneous tissue disorders Yellow skin	8.1% 5/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Vascular disorders Hypertension	32.3% 20/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Vascular disorders Hypotension	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.
Vascular disorders Thrombosis	1.6% 1/62 • Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented here are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated. The data collected and observed retrospectively in this study.

Additional Information

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Results disclosure agreements

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

Restriction type: OTHER