Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy |
Overall survival was defined as the time (in months) from second line sunitinib initiation to death. Participants were censored at their date of last follow-up. Kaplan-Meier method was used for analysis. |
From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
| Primary |
Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy |
TTD was defined as the time (in months) between initiation of second line sunitinib therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: disease progression was at least a 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 at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis. |
From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
| Primary |
Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy |
TTD was defined as the time (in months) between initiation of first line Immune-Oncologic therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per RECIST 1.1 criteria: disease progression was at least a 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 at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis. |
From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years) |
|
| Primary |
Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation |
Reasons for treatment discontinuation included disease progression, death, toxicity and other reasons including urosepsis, nausea, vomiting, diarrhea, comorbidity, and other unspecified. As per RECIST v1.1. criteria, disease progression was at least a 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 at least 1 new lesion. Unequivocal progression of existing non-target lesions. |
From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
| Primary |
Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy |
The objective response rate was defined as the percentage of participants with partial response (PR) and complete response (CR). As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. |
From the date of initiation of second line sunitinib to the date of PR and CR or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
| Primary |
Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy |
Progressive disease (PD) was defined as an increase in visible disease. According to RECIST 1.1; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. |
From the date of initiation of second line sunitinib to occurrence of disease progression, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
| Primary |
Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy |
Stable disease was defined as no change in size of visible disease. According to RECIST 1.1, stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease , taking as reference the smallest sum diameters while on study; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. |
From the date of initiation of second line sunitinib to the date stable disease or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
| Primary |
Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy |
|
From the discontinuation of immune-oncologic therapy to the initiation of sunitinib therapy (approximately up to 2 years) |
|
| Primary |
Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation |
Reasons for treatment discontinuation included disease progression, toxicity and other reasons including itchiness, mouth dryness, comorbidity, and other unspecified. As per RECIST 1.1 criteria: disease progression was at least a 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 at least 1 new lesion. Unequivocal progression of existing non-target lesions. |
From the date of initiation of first line Immune-Oncologic to discontinuation or follow-up (approximately up to 2 years) |
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