Carcinoma, Renal Cell, Advanced, Gastrointestinal Stroma Tumors, Lymphoma, Mantle-Cell
Conditions
Brief summary
The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use
Detailed description
Treatment of the metastatic renal cell carcinoma (mRCC) has experienced fundamental changes within a very short period of time. In the past few years, introduction of various new substances for the treatment of mRCC has therefore resulted in new scientific research questions. Temsirolimus and sunitinib are current standard therapies in the first-line treatment of mRCC. Inlyta® is a new substance that was developed for the treatment of mRCC after failure of sunitinib or cytokines. Since August 2009, Torisel® is available as another treatment option for patients with mantle cell lymphoma (MCL). In addition, Sutent® is used for patients with non-resectable / metastatic gastro-intestinal stroma tumors (GIST) after failure or intolerability of imatinib. The routine use of drugs in the usual clinical setting faces additional challenges that generally cannot be completely reflected by clinical trials. Therefore, the purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use. Therefore, the following information is of particular interest in the course of the investigation: * Efficacy (best response, overall survival, progression-free survival) * Tolerability of the therapy (assessed by the physician) * Safety profile (overall incidence of adverse events as well as side-effect rate) of subjects with mRCC, rMCL, and GIST under treatment with Torisel®, Sutent®, and/or Inlyta® * Profile, comorbidities, and characteristics of subjects treated with Torisel® Sutent®, and/or Inlyta® * The sequence of using the systemic therapies for RCC, MCL, and GIST * Patient survey on the quality of life of mRCC patients
Interventions
DRUGTemsirolimus
Non-interventional study. Treatment decision already made before inclusion into the registry.
DRUGSunitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
DRUGAxitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with proven tumor of RCC, MCL or GIST by histology. * Informed consent signed by patient.
Exclusion criteria
* Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | OS was defined as the time from initiation of treatment to death from any cause. In case a death was documented, but date of death was unknown, the date of death was substituted with the latest available date for the participant (last visit, last contact date, date of assessment). If no death was documented, participant was censored with the latest available contact date or assessment date within study. If these rules led to a missing duration or a negative duration, duration was set to maximum of (PFS,1 day). Progression free survival (PFS) was defined as time from initiation of treatment to documented disease progression or death from any cause. progression was defined as the enlargement of the measured sum by 20% or one or more new lesions. This outcome measure was analyzed using Kaplan-Meier method. |
| Progression Free Survival (PFS) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | PFS was defined as time from initiation of treatment to documented disease progression or death from any cause. The presence of a progression i.e. enlargement of the measured sum by 20% or one or more new lesions was confirmed, but (a) No date was documented: the date of last intake of study medication was used as date of progression, otherwise the date of the last visit with a documented non-progression was used as date of progression. (b) Dates within a visit and on final documentation were contradictory, the prior date was used. In case a death was documented within survival follow-up, but no progression was documented within regular study, the date of last visit plus 1 day was used as date of progression. In case no progression was documented, participant was censored with the latest available contact date or assessment date within study. In case these rules led to a missing duration or a negative duration, duration was set to 1 day. Kaplan-Meier method was used for analysis. |
| Number of Participants With Best Overall Response (BOR) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | BOR included Complete Remission (CR): complete disappearance of all lesions. Partial Remission (PR): Reduction of the measured total by at least 30%. Minor remission (MR): ≥10% decrease in the sum of longest diameters of target lesions but not a PR (\<30%). Stable Disease (SD): neither shrinkage for CR/PR nor increase for progressive disease (PD) taking as reference smallest sum of longest diameters (SLDs) since treatment start. PD: Enlargement of the measured sum by 20% or one or more new lesions. In this outcome measure, number of participants with best overall response were reported. |
| Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | In this outcome measure, number of participants were categorized according to physician's global assessment of effectiveness as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion. |
| Karnofsky Performance Status (KPS) Scale | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. |
| Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4) | Week 46 up to Week 55 post study inclusion | — |
| Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | 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) and missing was evaluated for MCL as planned. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | An adverse event (AE) was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. An SAE was any undesirable medical event that occurred in a participant received a medicinal product or dietary supplement (including infant formula) at any dose, and that resulted in death; was life-threatening; required an unforeseen hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial impairment of the ability to perform daily activities); resulted in a congenital malformation/birth defect. TEAEs were events between first dose of study drug and up to last documented follow-up visit that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and all non-serious adverse events. |
| Number of Participants Who Discontinued Treatment Due to Adverse Events | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | An AE was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. In this outcome measure number of participants who discontinued treatment due to adverse events were reported. |
| Number of Participants Categorized According to Physician's Global Tolerability Assessment | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | In this outcome measure, number of participants were categorized according to physician's global tolerability assessment as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion. |
| Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Week 46 up to Week 55 post study inclusion | — |
| Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c) | Week 46 up to Week 55 post study inclusion | — |
| Absolute Laboratory Values of Hematology Parameters: Hemoglobin | Week 46 up to Week 55 post study inclusion | — |
| Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Week 46 up to Week 55 post study inclusion | — |
| Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Week 46 up to Week 55 post study inclusion | — |
| Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | Week 46 up to Week 55 post study inclusion | — |
| Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin | Week 46 up to Week 55 post study inclusion | — |
| Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH) | Week 46 up to Week 55 post study inclusion | — |
Countries
Germany
Participant flow
Recruitment details
Data from eligible participants diagnosed with metastatic renal cell carcinoma (mRCC), relapsed or refractory mantle cell lymphoma (MCL) or gastrointestinal stromal tumors (GIST) and who were treated with temsirolimus, sunitinib and/or axitinib, as per routine clinical practice from January 2008 to December 2021 were observed in this prospective, non-interventional, STAR-TOR registry study.
Participants by arm
| Arm | Count |
|---|---|
| Participants With mRCC, MCL or GIST Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason. | 1,520 |
| Total | 1,520 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 81 |
| Overall Study | Premature discontinuation of documentation | 136 |
| Overall Study | Premature discontinuation of therapy | 1,013 |
| Overall Study | Type of study end not documented | 1 |
Baseline characteristics
| Characteristic | Participants With mRCC, MCL or GIST | — |
|---|---|---|
| Age, Customized GIST - Sunitinib 40 - <50 years | 1 Participants | — |
| Age, Customized GIST - Sunitinib 50 - <60 years | 3 Participants | — |
| Age, Customized GIST - Sunitinib 60 - <70 years | 7 Participants | — |
| Age, Customized GIST - Sunitinib 70 - <80 years | 12 Participants | — |
| Age, Customized GIST - Sunitinib 80 - <90 years | 2 Participants | — |
| Age, Customized GIST - Sunitinib 90 - <100 years | 0 Participants | — |
| Age, Customized GIST - Sunitinib Less than (<) 40 years | 1 Participants | — |
| Age, Customized GIST - Sunitinib Missing | 0 Participants | — |
| Age, Customized MCL - Temsirolimus 40 - <50 years | 0 Participants | — |
| Age, Customized MCL - Temsirolimus 50 - <60 years | 3 Participants | — |
| Age, Customized MCL - Temsirolimus 60 - <70 years | 11 Participants | — |
| Age, Customized MCL - Temsirolimus 70 - <80 years | 33 Participants | — |
| Age, Customized MCL - Temsirolimus 80 - <90 years | 11 Participants | — |
| Age, Customized MCL - Temsirolimus 90 - <100 years | 1 Participants | — |
| Age, Customized MCL - Temsirolimus Less than (<) 40 years | 0 Participants | — |
| Age, Customized MCL - Temsirolimus Missing | 0 Participants | — |
| Age, Customized mRCC - Axitinib 40 - <50 years | 5 Participants | — |
| Age, Customized mRCC - Axitinib 50 - <60 years | 47 Participants | — |
| Age, Customized mRCC - Axitinib 60 - <70 years | 67 Participants | — |
| Age, Customized mRCC - Axitinib 70 - <80 years | 92 Participants | — |
| Age, Customized mRCC - Axitinib 80 - <90 years | 23 Participants | — |
| Age, Customized mRCC - Axitinib 90 - <100 years | 0 Participants | — |
| Age, Customized mRCC - Axitinib Less than (<) 40 years | 3 Participants | — |
| Age, Customized mRCC - Axitinib Missing | 0 Participants | — |
| Age, Customized mRCC - Sunitinib 40 - <50 years | 29 Participants | — |
| Age, Customized mRCC - Sunitinib 50 - <60 years | 128 Participants | — |
| Age, Customized mRCC - Sunitinib 60 - <70 years | 222 Participants | — |
| Age, Customized mRCC - Sunitinib 70 - <80 years | 252 Participants | — |
| Age, Customized mRCC - Sunitinib 80 - <90 years | 66 Participants | — |
| Age, Customized mRCC - Sunitinib 90 - <100 years | 0 Participants | — |
| Age, Customized mRCC - Sunitinib Less than (<) 40 years | 5 Participants | — |
| Age, Customized mRCC - Sunitinib Missing | 0 Participants | — |
| Age, Customized mRCC - Temsirolimus 40 - <50 years | 34 Participants | — |
| Age, Customized mRCC - Temsirolimus 50 - <60 years | 106 Participants | — |
| Age, Customized mRCC - Temsirolimus 60 - <70 years | 188 Participants | — |
| Age, Customized mRCC - Temsirolimus 70 - <80 years | 238 Participants | — |
| Age, Customized mRCC - Temsirolimus 80 - <90 years | 36 Participants | — |
| Age, Customized mRCC - Temsirolimus 90 - <100 years | 0 Participants | — |
| Age, Customized mRCC - Temsirolimus Less than (<) 40 years | 2 Participants | — |
| Age, Customized mRCC - Temsirolimus Missing | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized GIST - Sunitinib Female | 8 Participants | — |
| Sex/Gender, Customized GIST - Sunitinib Male | 17 Participants | — |
| Sex/Gender, Customized GIST - Sunitinib Missing | 1 Participants | — |
| Sex/Gender, Customized MCL - Temsirolimus Female | 18 Participants | — |
| Sex/Gender, Customized MCL - Temsirolimus Male | 41 Participants | — |
| Sex/Gender, Customized MCL - Temsirolimus Missing | 0 Participants | — |
| Sex/Gender, Customized mRCC - Axitinib Female | 71 Participants | — |
| Sex/Gender, Customized mRCC - Axitinib Male | 163 Participants | — |
| Sex/Gender, Customized mRCC - Axitinib Missing | 3 Participants | — |
| Sex/Gender, Customized mRCC - Sunitinib Female | 187 Participants | — |
| Sex/Gender, Customized mRCC - Sunitinib Male | 510 Participants | — |
| Sex/Gender, Customized mRCC - Sunitinib Missing | 5 Participants | — |
| Sex/Gender, Customized mRCC - Temsirolimus Female | 191 Participants | — |
| Sex/Gender, Customized mRCC - Temsirolimus Male | 410 Participants | — |
| Sex/Gender, Customized mRCC - Temsirolimus Missing | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 440 / 605 | 420 / 702 | 163 / 237 | 40 / 59 | 16 / 26 |
| other Total, other adverse events | 342 / 605 | 485 / 702 | 148 / 237 | 45 / 59 | 18 / 26 |
| serious Total, serious adverse events | 269 / 605 | 284 / 702 | 111 / 237 | 26 / 59 | 11 / 26 |
Outcome results
Primary
Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH)
Time frame: Week 46 up to Week 55 post study inclusion
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | LDH | 224.8 Units per liter | Standard Deviation 88.2 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | ALP | 95.8 Units per liter | Standard Deviation 53.5 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | AST | 23.1 Units per liter | Standard Deviation 8.2 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | ALT | 20.2 Units per liter | Standard Deviation 8.3 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | LDH | 245.1 Units per liter | Standard Deviation 67.2 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | ALP | 77.9 Units per liter | Standard Deviation 30.6 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | ALT | 25.9 Units per liter | Standard Deviation 17.5 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | AST | 29.6 Units per liter | Standard Deviation 12.8 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | ALP | 91.8 Units per liter | Standard Deviation 43.2 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | AST | 44.3 Units per liter | Standard Deviation 84.3 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | ALT | 34.7 Units per liter | Standard Deviation 71.8 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | LDH | 235.8 Units per liter | Standard Deviation 126.9 |
| MCL - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | AST | 28.0 Units per liter | — |
| MCL - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | ALP | 130.0 Units per liter | — |
| MCL - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | ALT | 24.0 Units per liter | — |
| MCL - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | LDH | 256.0 Units per liter | — |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | AST | 24.6 Units per liter | Standard Deviation 6.4 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | ALT | 22.9 Units per liter | Standard Deviation 7.5 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | LDH | 227.8 Units per liter | Standard Deviation 45.6 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) | ALP | 79.3 Units per liter | Standard Deviation 50.7 |
Primary
Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin
Time frame: Week 46 up to Week 55 post study inclusion
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for albumin in MCL arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin | 31.1 Grams per liter | Standard Deviation 17.1 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin | 33.6 Grams per liter | Standard Deviation 14.4 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin | 31.6 Grams per liter | Standard Deviation 14.8 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin | 42.0 Grams per liter | — |
Primary
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose
Time frame: Week 46 up to Week 55 post study inclusion
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Glucose | 54.7 Millimoles per liter | Standard Deviation 62.6 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Triglycerides | 3.2 Millimoles per liter | Standard Deviation 3.4 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Potassium | 4.3 Millimoles per liter | Standard Deviation 0.6 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Sodium | 136.0 Millimoles per liter | Standard Deviation 19.1 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Calcium | 2.3 Millimoles per liter | Standard Deviation 0.4 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Magnesium | 1.2 Millimoles per liter | Standard Deviation 0.7 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Cholesterol | 6.0 Millimoles per liter | Standard Deviation 1.9 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Phosphate | 1.4 Millimoles per liter | Standard Deviation 0.9 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Triglycerides | 2.4 Millimoles per liter | Standard Deviation 1.1 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Magnesium | 0.8 Millimoles per liter | Standard Deviation 0.3 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Sodium | 139.1 Millimoles per liter | Standard Deviation 3.6 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Calcium | 2.3 Millimoles per liter | Standard Deviation 0.3 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Phosphate | 1.1 Millimoles per liter | Standard Deviation 0.5 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Potassium | 4.5 Millimoles per liter | Standard Deviation 0.6 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Glucose | 39.4 Millimoles per liter | Standard Deviation 52.4 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Cholesterol | 5.1 Millimoles per liter | Standard Deviation 1.3 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Phosphate | 1.4 Millimoles per liter | Standard Deviation 0.9 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Calcium | 2.6 Millimoles per liter | Standard Deviation 1.1 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Sodium | 138.1 Millimoles per liter | Standard Deviation 4 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Potassium | 4.4 Millimoles per liter | Standard Deviation 0.6 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Magnesium | 0.7 Millimoles per liter | Standard Deviation 0.1 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Cholesterol | 6.6 Millimoles per liter | Standard Deviation 1.3 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Triglycerides | 3.5 Millimoles per liter | Standard Deviation 2.5 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Glucose | 71.4 Millimoles per liter | Standard Deviation 78.4 |
| MCL - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Sodium | 138.0 Millimoles per liter | — |
| MCL - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Calcium | 2.4 Millimoles per liter | Standard Deviation 0.1 |
| MCL - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Potassium | 3.6 Millimoles per liter | Standard Deviation 0 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Glucose | 77.2 Millimoles per liter | Standard Deviation 143.2 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Triglycerides | 5.2 Millimoles per liter | Standard Deviation 3.4 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Phosphate | 0.9 Millimoles per liter | Standard Deviation 0.2 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Calcium | 2.3 Millimoles per liter | Standard Deviation 0.1 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Magnesium | 0.9 Millimoles per liter | — |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Potassium | 4.1 Millimoles per liter | Standard Deviation 0.9 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Cholesterol | 5.9 Millimoles per liter | Standard Deviation 2.1 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose | Sodium | 139.0 Millimoles per liter | Standard Deviation 2.7 |
Primary
Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin
Time frame: Week 46 up to Week 55 post study inclusion
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Creatinine | 1.4 Milligrams per deciliter | Standard Deviation 0.5 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Total bilirubin | 0.9 Milligrams per deciliter | Standard Deviation 1.7 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Creatinine | 1.4 Milligrams per deciliter | Standard Deviation 0.8 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Total bilirubin | 0.7 Milligrams per deciliter | Standard Deviation 1.1 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Creatinine | 1.3 Milligrams per deciliter | Standard Deviation 0.5 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Total bilirubin | 0.5 Milligrams per deciliter | Standard Deviation 0.3 |
| MCL - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Total bilirubin | 0.3 Milligrams per deciliter | — |
| MCL - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Creatinine | 0.7 Milligrams per deciliter | Standard Deviation 0 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Creatinine | 1.1 Milligrams per deciliter | Standard Deviation 0.3 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin | Total bilirubin | 0.4 Milligrams per deciliter | Standard Deviation 0.1 |
Primary
Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH)
Time frame: Week 46 up to Week 55 post study inclusion
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for TSH in MCL arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH) | 1.5 Milliunits per liter | Standard Deviation 1.4 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH) | 3.5 Milliunits per liter | Standard Deviation 3.4 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH) | 3.4 Milliunits per liter | Standard Deviation 2.4 |
| GIST - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH) | 1.6 Milliunits per liter | Standard Deviation 1.1 |
Primary
Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4)
Time frame: Week 46 up to Week 55 post study inclusion
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for fT3 and fT4 in MCL and GIST arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4) | fT3 | 3.5 Picomoles per liter | — |
| mRCC - Temsirolimus | Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4) | fT4 | 15.4 Picomoles per liter | — |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4) | fT3 | 3.7 Picomoles per liter | Standard Deviation 1 |
| mRCC - Sunitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4) | fT4 | 14.8 Picomoles per liter | Standard Deviation 4.8 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4) | fT3 | 3.8 Picomoles per liter | Standard Deviation 1.3 |
| mRCC - Axitinib | Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4) | fT4 | 13.7 Picomoles per liter | Standard Deviation 6.1 |
Primary
Absolute Laboratory Values of Hematology Parameters: Hemoglobin
Time frame: Week 46 up to Week 55 post study inclusion
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mRCC - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Hemoglobin | 11.2 Grams per deciliter | Standard Deviation 1.6 |
| mRCC - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Hemoglobin | 12.2 Grams per deciliter | Standard Deviation 2 |
| mRCC - Axitinib | Absolute Laboratory Values of Hematology Parameters: Hemoglobin | 14.4 Grams per deciliter | Standard Deviation 1.7 |
| MCL - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Hemoglobin | 12.6 Grams per deciliter | Standard Deviation 0.8 |
| GIST - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Hemoglobin | 11.9 Grams per deciliter | Standard Deviation 1.2 |
Primary
Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c)
Time frame: Week 46 up to Week 55 post study inclusion
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for HbA1c in MCL arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mRCC - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c) | 7.9 Percentage of HbA1c | Standard Deviation 1.2 |
| mRCC - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c) | 5.8 Percentage of HbA1c | Standard Deviation 0.8 |
| mRCC - Axitinib | Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c) | 5.9 Percentage of HbA1c | Standard Deviation 0.9 |
| GIST - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c) | 7.5 Percentage of HbA1c | Standard Deviation 3.2 |
Primary
Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit
Time frame: Week 46 up to Week 55 post study inclusion
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mRCC - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Eosinophils | 2.6 Percentage of blood cells in blood | Standard Deviation 1.9 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Basophils | 0.4 Percentage of blood cells in blood | Standard Deviation 0.4 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Hematocrit | 33.8 Percentage of blood cells in blood | Standard Deviation 3.5 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Lymphocytes | 18.8 Percentage of blood cells in blood | Standard Deviation 8.5 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Monocytes | 8.9 Percentage of blood cells in blood | Standard Deviation 3.7 |
| mRCC - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Neutrophils | 67.1 Percentage of blood cells in blood | Standard Deviation 13.2 |
| mRCC - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Monocytes | 8.7 Percentage of blood cells in blood | Standard Deviation 3.3 |
| mRCC - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Eosinophils | 2.9 Percentage of blood cells in blood | Standard Deviation 2.3 |
| mRCC - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Hematocrit | 37.0 Percentage of blood cells in blood | Standard Deviation 5.2 |
| mRCC - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Lymphocytes | 31.1 Percentage of blood cells in blood | Standard Deviation 12 |
| mRCC - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Neutrophils | 56.0 Percentage of blood cells in blood | Standard Deviation 14 |
| mRCC - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Basophils | 0.4 Percentage of blood cells in blood | Standard Deviation 0.3 |
| mRCC - Axitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Hematocrit | 42.7 Percentage of blood cells in blood | Standard Deviation 5.2 |
| mRCC - Axitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Neutrophils | 64.4 Percentage of blood cells in blood | Standard Deviation 10.8 |
| mRCC - Axitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Lymphocytes | 23.7 Percentage of blood cells in blood | Standard Deviation 9.1 |
| mRCC - Axitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Monocytes | 8.4 Percentage of blood cells in blood | Standard Deviation 2.3 |
| mRCC - Axitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Eosinophils | 3.0 Percentage of blood cells in blood | Standard Deviation 1.4 |
| mRCC - Axitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Basophils | 0.5 Percentage of blood cells in blood | Standard Deviation 0.4 |
| MCL - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Eosinophils | 4.3 Percentage of blood cells in blood | Standard Deviation 2.8 |
| MCL - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Monocytes | 14.2 Percentage of blood cells in blood | Standard Deviation 6.9 |
| MCL - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Neutrophils | 58.7 Percentage of blood cells in blood | Standard Deviation 1 |
| MCL - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Basophils | 0.4 Percentage of blood cells in blood | Standard Deviation 0.1 |
| MCL - Temsirolimus | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Lymphocytes | 22.5 Percentage of blood cells in blood | Standard Deviation 8.6 |
| GIST - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Monocytes | 8.8 Percentage of blood cells in blood | Standard Deviation 2.9 |
| GIST - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Eosinophils | 2.1 Percentage of blood cells in blood | Standard Deviation 2.5 |
| GIST - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Basophils | 0.2 Percentage of blood cells in blood | Standard Deviation 0.1 |
| GIST - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Lymphocytes | 28.9 Percentage of blood cells in blood | Standard Deviation 12.6 |
| GIST - Sunitinib | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Neutrophils | 58.7 Percentage of blood cells in blood | Standard Deviation 13.7 |
Primary
Karnofsky Performance Status (KPS) Scale
Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.
Time frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Population: EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed for MCL.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mRCC - Temsirolimus | Karnofsky Performance Status (KPS) Scale | 71.9 Units on a scale | Standard Deviation 15.4 |
| mRCC - Sunitinib | Karnofsky Performance Status (KPS) Scale | 78.8 Units on a scale | Standard Deviation 14.1 |
| mRCC - Axitinib | Karnofsky Performance Status (KPS) Scale | 77.9 Units on a scale | Standard Deviation 13.2 |
| MCL - Temsirolimus | Karnofsky Performance Status (KPS) Scale | 77.8 Units on a scale | Standard Deviation 8.8 |
Primary
Number of Participants Categorized According to Physician's Global Assessment of Effectiveness
In this outcome measure, number of participants were categorized according to physician's global assessment of effectiveness as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion.
Time frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Population: EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mRCC - Temsirolimus | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Insufficient | 159 Participants |
| mRCC - Temsirolimus | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Very good | 35 Participants |
| mRCC - Temsirolimus | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Missing | 25 Participants |
| mRCC - Temsirolimus | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Good | 176 Participants |
| mRCC - Temsirolimus | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Moderate | 110 Participants |
| mRCC - Sunitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Insufficient | 150 Participants |
| mRCC - Sunitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Moderate | 112 Participants |
| mRCC - Sunitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Good | 227 Participants |
| mRCC - Sunitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Missing | 29 Participants |
| mRCC - Sunitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Very good | 57 Participants |
| mRCC - Axitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Moderate | 43 Participants |
| mRCC - Axitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Very good | 6 Participants |
| mRCC - Axitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Good | 78 Participants |
| mRCC - Axitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Insufficient | 60 Participants |
| mRCC - Axitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Missing | 8 Participants |
| MCL - Temsirolimus | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Missing | 2 Participants |
| MCL - Temsirolimus | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Very good | 2 Participants |
| MCL - Temsirolimus | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Insufficient | 12 Participants |
| MCL - Temsirolimus | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Moderate | 12 Participants |
| MCL - Temsirolimus | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Good | 20 Participants |
| GIST - Sunitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Moderate | 3 Participants |
| GIST - Sunitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Insufficient | 8 Participants |
| GIST - Sunitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Very good | 0 Participants |
| GIST - Sunitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Missing | 2 Participants |
| GIST - Sunitinib | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | Good | 10 Participants |
Primary
Number of Participants Categorized According to Physician's Global Tolerability Assessment
In this outcome measure, number of participants were categorized according to physician's global tolerability assessment as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion.
Time frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mRCC - Temsirolimus | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Insufficient | 34 Participants |
| mRCC - Temsirolimus | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Very good | 93 Participants |
| mRCC - Temsirolimus | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Missing | 4 Participants |
| mRCC - Temsirolimus | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Good | 306 Participants |
| mRCC - Temsirolimus | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Moderate | 68 Participants |
| mRCC - Sunitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Insufficient | 40 Participants |
| mRCC - Sunitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Moderate | 107 Participants |
| mRCC - Sunitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Good | 370 Participants |
| mRCC - Sunitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Missing | 10 Participants |
| mRCC - Sunitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Very good | 49 Participants |
| mRCC - Axitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Moderate | 31 Participants |
| mRCC - Axitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Very good | 21 Participants |
| mRCC - Axitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Good | 123 Participants |
| mRCC - Axitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Insufficient | 18 Participants |
| mRCC - Axitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Missing | 2 Participants |
| MCL - Temsirolimus | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Missing | 2 Participants |
| MCL - Temsirolimus | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Very good | 5 Participants |
| MCL - Temsirolimus | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Insufficient | 4 Participants |
| MCL - Temsirolimus | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Moderate | 13 Participants |
| MCL - Temsirolimus | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Good | 25 Participants |
| GIST - Sunitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Moderate | 3 Participants |
| GIST - Sunitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Insufficient | 0 Participants |
| GIST - Sunitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Very good | 3 Participants |
| GIST - Sunitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Missing | 2 Participants |
| GIST - Sunitinib | Number of Participants Categorized According to Physician's Global Tolerability Assessment | Good | 16 Participants |
Primary
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma
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) and missing was evaluated for MCL as planned.
Time frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Population: EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mRCC - Temsirolimus | Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma | ECOG: 0 | 5 Participants |
| mRCC - Temsirolimus | Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma | ECOG: 1 | 24 Participants |
| mRCC - Temsirolimus | Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma | ECOG: 2 | 13 Participants |
| mRCC - Temsirolimus | Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma | Missing | 6 Participants |
Primary
Number of Participants Who Discontinued Treatment Due to Adverse Events
An AE was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. In this outcome measure number of participants who discontinued treatment due to adverse events were reported.
Time frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mRCC - Temsirolimus | Number of Participants Who Discontinued Treatment Due to Adverse Events | 108 Participants |
| mRCC - Sunitinib | Number of Participants Who Discontinued Treatment Due to Adverse Events | 142 Participants |
| mRCC - Axitinib | Number of Participants Who Discontinued Treatment Due to Adverse Events | 60 Participants |
| MCL - Temsirolimus | Number of Participants Who Discontinued Treatment Due to Adverse Events | 17 Participants |
| GIST - Sunitinib | Number of Participants Who Discontinued Treatment Due to Adverse Events | 5 Participants |
Primary
Number of Participants With Best Overall Response (BOR)
BOR included Complete Remission (CR): complete disappearance of all lesions. Partial Remission (PR): Reduction of the measured total by at least 30%. Minor remission (MR): ≥10% decrease in the sum of longest diameters of target lesions but not a PR (\<30%). Stable Disease (SD): neither shrinkage for CR/PR nor increase for progressive disease (PD) taking as reference smallest sum of longest diameters (SLDs) since treatment start. PD: Enlargement of the measured sum by 20% or one or more new lesions. In this outcome measure, number of participants with best overall response were reported.
Time frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Population: EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, 'Number Analyzed' signifies those participants who were evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mRCC - Temsirolimus | Number of Participants With Best Overall Response (BOR) | CR | 5 Participants |
| mRCC - Temsirolimus | Number of Participants With Best Overall Response (BOR) | Missing | 8 Participants |
| mRCC - Temsirolimus | Number of Participants With Best Overall Response (BOR) | Response could not be assessed | 88 Participants |
| mRCC - Temsirolimus | Number of Participants With Best Overall Response (BOR) | MR | 0 Participants |
| mRCC - Temsirolimus | Number of Participants With Best Overall Response (BOR) | PR | 70 Participants |
| mRCC - Temsirolimus | Number of Participants With Best Overall Response (BOR) | SD | 237 Participants |
| mRCC - Temsirolimus | Number of Participants With Best Overall Response (BOR) | PD | 169 Participants |
| mRCC - Sunitinib | Number of Participants With Best Overall Response (BOR) | PD | 146 Participants |
| mRCC - Sunitinib | Number of Participants With Best Overall Response (BOR) | SD | 221 Participants |
| mRCC - Sunitinib | Number of Participants With Best Overall Response (BOR) | PR | 166 Participants |
| mRCC - Sunitinib | Number of Participants With Best Overall Response (BOR) | CR | 40 Participants |
| mRCC - Sunitinib | Number of Participants With Best Overall Response (BOR) | Response could not be assessed | 59 Participants |
| mRCC - Sunitinib | Number of Participants With Best Overall Response (BOR) | MR | 0 Participants |
| mRCC - Sunitinib | Number of Participants With Best Overall Response (BOR) | Missing | 19 Participants |
| mRCC - Axitinib | Number of Participants With Best Overall Response (BOR) | SD | 75 Participants |
| mRCC - Axitinib | Number of Participants With Best Overall Response (BOR) | CR | 3 Participants |
| mRCC - Axitinib | Number of Participants With Best Overall Response (BOR) | PR | 39 Participants |
| mRCC - Axitinib | Number of Participants With Best Overall Response (BOR) | MR | 0 Participants |
| mRCC - Axitinib | Number of Participants With Best Overall Response (BOR) | PD | 58 Participants |
| mRCC - Axitinib | Number of Participants With Best Overall Response (BOR) | Response could not be assessed | 39 Participants |
| mRCC - Axitinib | Number of Participants With Best Overall Response (BOR) | Missing | 7 Participants |
| MCL - Temsirolimus | Number of Participants With Best Overall Response (BOR) | MR | 3 Participants |
| MCL - Temsirolimus | Number of Participants With Best Overall Response (BOR) | PD | 17 Participants |
| MCL - Temsirolimus | Number of Participants With Best Overall Response (BOR) | PR | 14 Participants |
| MCL - Temsirolimus | Number of Participants With Best Overall Response (BOR) | Missing | 0 Participants |
| MCL - Temsirolimus | Number of Participants With Best Overall Response (BOR) | Response could not be assessed | 10 Participants |
| MCL - Temsirolimus | Number of Participants With Best Overall Response (BOR) | CR | 1 Participants |
| MCL - Temsirolimus | Number of Participants With Best Overall Response (BOR) | SD | 10 Participants |
| GIST - Sunitinib | Number of Participants With Best Overall Response (BOR) | MR | 0 Participants |
| GIST - Sunitinib | Number of Participants With Best Overall Response (BOR) | Missing | 0 Participants |
| GIST - Sunitinib | Number of Participants With Best Overall Response (BOR) | Response could not be assessed | 1 Participants |
| GIST - Sunitinib | Number of Participants With Best Overall Response (BOR) | PD | 6 Participants |
| GIST - Sunitinib | Number of Participants With Best Overall Response (BOR) | PR | 6 Participants |
| GIST - Sunitinib | Number of Participants With Best Overall Response (BOR) | CR | 0 Participants |
| GIST - Sunitinib | Number of Participants With Best Overall Response (BOR) | SD | 11 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. An SAE was any undesirable medical event that occurred in a participant received a medicinal product or dietary supplement (including infant formula) at any dose, and that resulted in death; was life-threatening; required an unforeseen hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial impairment of the ability to perform daily activities); resulted in a congenital malformation/birth defect. TEAEs were events between first dose of study drug and up to last documented follow-up visit that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and all non-serious adverse events.
Time frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Population: Safety analysis set (SAS) comprised of all prospectively documented participants with histologically proven diagnosis of either mRCC, MCL or GIST and at least 1 documented administration of temsirolimus, sunitinib or axitinib or any non-Pfizer treatment. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mRCC - Temsirolimus | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 269 Participants |
| mRCC - Temsirolimus | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 460 Participants |
| mRCC - Sunitinib | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 585 Participants |
| mRCC - Sunitinib | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 284 Participants |
| mRCC - Axitinib | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 111 Participants |
| mRCC - Axitinib | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 187 Participants |
| MCL - Temsirolimus | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 53 Participants |
| MCL - Temsirolimus | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 26 Participants |
| GIST - Sunitinib | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 11 Participants |
| GIST - Sunitinib | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 20 Participants |
Primary
Overall Survival (OS)
OS was defined as the time from initiation of treatment to death from any cause. In case a death was documented, but date of death was unknown, the date of death was substituted with the latest available date for the participant (last visit, last contact date, date of assessment). If no death was documented, participant was censored with the latest available contact date or assessment date within study. If these rules led to a missing duration or a negative duration, duration was set to maximum of (PFS,1 day). Progression free survival (PFS) was defined as time from initiation of treatment to documented disease progression or death from any cause. progression was defined as the enlargement of the measured sum by 20% or one or more new lesions. This outcome measure was analyzed using Kaplan-Meier method.
Time frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Population: Effectiveness analysis set (EAS): all participants included in study with at least 1 information on: date of death, progression, assessment of response to therapy by physician or assessment to either effectiveness or tolerability of therapy by physician. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| mRCC - Temsirolimus | Overall Survival (OS) | 11.04 Months |
| mRCC - Sunitinib | Overall Survival (OS) | 25.36 Months |
| mRCC - Axitinib | Overall Survival (OS) | 18.37 Months |
| MCL - Temsirolimus | Overall Survival (OS) | 15.11 Months |
| GIST - Sunitinib | Overall Survival (OS) | 16.30 Months |
Primary
Progression Free Survival (PFS)
PFS was defined as time from initiation of treatment to documented disease progression or death from any cause. The presence of a progression i.e. enlargement of the measured sum by 20% or one or more new lesions was confirmed, but (a) No date was documented: the date of last intake of study medication was used as date of progression, otherwise the date of the last visit with a documented non-progression was used as date of progression. (b) Dates within a visit and on final documentation were contradictory, the prior date was used. In case a death was documented within survival follow-up, but no progression was documented within regular study, the date of last visit plus 1 day was used as date of progression. In case no progression was documented, participant was censored with the latest available contact date or assessment date within study. In case these rules led to a missing duration or a negative duration, duration was set to 1 day. Kaplan-Meier method was used for analysis.
Time frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Population: EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| mRCC - Temsirolimus | Progression Free Survival (PFS) | 3.91 Months |
| mRCC - Sunitinib | Progression Free Survival (PFS) | 6.93 Months |
| mRCC - Axitinib | Progression Free Survival (PFS) | 5.75 Months |
| MCL - Temsirolimus | Progression Free Survival (PFS) | 3.68 Months |
| GIST - Sunitinib | Progression Free Survival (PFS) | 10.32 Months |