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| ID | Type | Description | Link |
|---|---|---|---|
| INHIBITOR | Other Identifier | Alias Study Number |
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The principal objective of the study is to evaluate the efficacy and safety of temsirolimus use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.
There is not sampling method
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients that received treatment with Temsirolimus | Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temsirolimus (Non-Interventional Study) | Other | There is not any intervention in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma. | From initiation of treatment up to disease progression (up to 80 months) |
| Percentage of Participants With Objective Response | Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.) | From initiation of treatment up to disease progression (up to 80 months) |
| Duration of Response (DOR) | Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2. |
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Inclusion Criteria:
Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
Exclusion Criteria:
Patients that do not have a minimum (pre-specified) of data in their clinical record.
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Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña | A Coruña | A Coruña | 15006 | Spain | ||
| Hospital de La Santa Creu I Sant Pau |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 243 participants were enrolled in the study, out of which 242 participants received treatment in reporting group "RCC: Temsirolimus", "MCL: Temsirolimus" or "MCL: Temsirolimus + Rituximab"
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| ID | Title | Description |
|---|---|---|
| FG000 | RCC: Temsirolimus | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. |
| FG001 | MCL: Temsirolimus |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From initiation of treatment up to disease progression (up to 80 months) |
| Overall Survival (OS) | Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive. | From initiation of treatment untill death (up to 80 months) |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs). | Baseline to the 28 calendar days after the last administration of study drug (upto 80 months) |
| Barcelona |
| Barcelona |
| 08025 |
| Spain |
| Hospital Vall D'Hebron | Barcelona | Barcelona | 08035 | Spain |
| Hospital del Mar | Barcelona | Barcelona | 8940 | Spain |
| Hospital de Cabueñes | Cabueñes | Gijon | 33394 | Spain |
| Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera | A Coruña | La Coruña | 15006 | Spain |
| Hospital Clinico Universitario | Santiago de Compostela | La Coruña | 15706 | Spain |
| Complejo Hospitalario Materno-Infantil Insular de Las Palmas | Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital de Madrid Norte - Sanchinarro | Madrid | Madrid | 28050 | Spain |
| Hospital de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital Provincial de Castellon | Castellon | Valencia | 12002 | Spain |
| Complejo AAsistencial de Avilla | Ávila | 05004 | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. |
| FG002 | MCL: Temsirolimus + Rituximab | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline population included all participants with RCC or MCL who received atleast 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | RCC: Temsirolimus | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. |
| BG001 | MCL: Temsirolimus | Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. |
| BG002 | MCL: Temsirolimus + Rituximab | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma. | Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | months | From initiation of treatment up to disease progression (up to 80 months) |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Objective Response | Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.) | Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. | Posted | Number | percentage of participants | From initiation of treatment up to disease progression (up to 80 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Duration of Response (DOR) | Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2. | Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From initiation of treatment up to disease progression (up to 80 months) |
| |||||||||||||||||||||||||||||||||
| Primary | Overall Survival (OS) | Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive. | Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | months | From initiation of treatment untill death (up to 80 months) |
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs). | Safety population included all participants with RCC or MCL who received atleast 1 dose of study treatment. | Posted | Number | participants | Baseline to the 28 calendar days after the last administration of study drug (upto 80 months) |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RCC: Temsirolimus | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. | 18 | 193 | 142 | 193 | ||
| EG001 | MCL: Temsirolimus | Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. | 3 | 23 | 18 | 23 | ||
| EG002 | MCL: Temsirolimus + Rituximab | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. | 7 | 26 | 14 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Haemangioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.1 | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Others | General disorders | no coding dictionary | Non-systematic Assessment | No coding was available in MedDRA dictionary for this event |
|
| Aspergillus infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Bone marrow toxicity | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dermal toxicity | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Nail toxicity | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Gastrointestinal candidiasis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Others | General disorders | MedDRA v18.1 | Non-systematic Assessment | No coding was available in MedDRA dictionary for this event |
|
| Herpes zoster | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA v18.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 800-718-1021 | 001 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C401859 | temsirolimus |
Not provided
Not provided
Not provided
| Male |
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Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
| OG002 | MCC: Temsirolimus + Rituximab | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
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Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
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| OG002 | MCC: Temsirolimus + Rituximab | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
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