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The study tests the safety and efficacy of axitinib in patients who have the hematologic disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who have poor prognosis before entering the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG-013736 (Axitinib) | Drug | patients were treated with axitinib at starting dose of 5 mg BID continuous dosing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | Participants with OR based on a assessment of confirmed complete remission (CR) or partial remission (PR) according to Cheson criteria for Acute myeloid leukemia (AML) and Myelodysplastic syndrome (MDS). CR: those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood value lasting at least 1 month and 2 months for AML and MDS respectively. PR : those with all criteria for CR except 5-25 % blasts in bone marrow and at least 50% decrease in blast over pretreatment for AML and MDS respectively. | Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 4 weeks up to 35 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hematologic Improvement (HI) | HI was described by the number of individual and positively affected cell lines (Erythroid response, Platelet response, Neutrophil response). Improvements must last at least 2 months. | Baseline, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Axitinib | Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Axitinib | Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Percentage of Participants With Objective Response (OR) | Participants with OR based on a assessment of confirmed complete remission (CR) or partial remission (PR) according to Cheson criteria for Acute myeloid leukemia (AML) and Myelodysplastic syndrome (MDS). CR: those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood value lasting at least 1 month and 2 months for AML and MDS respectively. PR : those with all criteria for CR except 5-25 % blasts in bone marrow and at least 50% decrease in blast over pretreatment for AML and MDS respectively. | Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 4 weeks up to 35 weeks |
|
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious 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 | Axitinib | Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
Not provided
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| Duration of Response (DR) | Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response. | First documentation of objective response until objective disease progression or discontinuation from the study due to any cause assessed every 4 weeks up to 35 weeks |
| Bone Marrow Micro Vessel Density (MVD) | Bone marrow MVD in tumors is a measure of angiogenesis and a prognostic indicator that correlates with an increased risk of metastasis in various cancers and with overall and relapse free survival in participants with AML or MDS. Bone marrow biopsies and bone marrow clot samples were assessed for MVD (cluster of differentiation 31 [CD31] staining). | Day 1, Week 2 thereafter every 4 weeks up to 35 weeks |
| Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) and VEFGR Receptor 2 (VEGFR-2) Phosphorylation | Vascular endothelial growth factor (VEGF) promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Mononuclear (MNC) cell VEGF receptor expression and phosphorylation was assessed by in situ western blot analysis. VEGFR-1 and VEGFR-2 evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot. | Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose) |
| Plasma Vascular Endothelial Growth Factor (VEGF) Concentration | VEGF promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Plasma VEGF concentration evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot. | Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose) |
| Population Pharmacokinetics of Axitinib (AG-013736) | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. | Day 1 (pre-dose) and every 4 weeks up to 35 weeks |
| Overall Survival (OS) | Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact. | Baseline to death due to any cause or at least every 3 months after discontinuation of study treatment |
| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Axitinib |
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred. |
|
|
| Secondary | Percentage of Participants With Hematologic Improvement (HI) | HI was described by the number of individual and positively affected cell lines (Erythroid response, Platelet response, Neutrophil response). Improvements must last at least 2 months. | Analysis for this particular endpoint was not conducted due to lack of efficacy. | Posted | Median | 95% Confidence Interval | Percentage of participants | Baseline, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose) |
|
|
| Secondary | Duration of Response (DR) | Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response. | Analysis for this particular endpoint was not conducted due to lack of efficacy. | Posted | Median | 95% Confidence Interval | Days | First documentation of objective response until objective disease progression or discontinuation from the study due to any cause assessed every 4 weeks up to 35 weeks |
|
|
| Secondary | Bone Marrow Micro Vessel Density (MVD) | Bone marrow MVD in tumors is a measure of angiogenesis and a prognostic indicator that correlates with an increased risk of metastasis in various cancers and with overall and relapse free survival in participants with AML or MDS. Bone marrow biopsies and bone marrow clot samples were assessed for MVD (cluster of differentiation 31 [CD31] staining). | Data was not summarized for this particular endpoint due to lack of efficacy. | Posted | Mean | Standard Deviation | vessels/square millimeter (mm^2) | Day 1, Week 2 thereafter every 4 weeks up to 35 weeks |
|
|
| Secondary | Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) and VEFGR Receptor 2 (VEGFR-2) Phosphorylation | Vascular endothelial growth factor (VEGF) promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Mononuclear (MNC) cell VEGF receptor expression and phosphorylation was assessed by in situ western blot analysis. VEGFR-1 and VEGFR-2 evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot. | Data was not summarized for this particular endpoint due to lack of efficacy. | Posted | Mean | Standard Deviation | picograms (pg)/mL | Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose) |
|
|
| Secondary | Plasma Vascular Endothelial Growth Factor (VEGF) Concentration | VEGF promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Plasma VEGF concentration evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot. | Data was not summarized for this particular endpoint due to lack of efficacy. | Posted | Mean | Standard Deviation | pg/mL | Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose) |
|
|
| Secondary | Population Pharmacokinetics of Axitinib (AG-013736) | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. | Not Posted | Mean | Standard Deviation | ng/mL | Day 1 (pre-dose) and every 4 weeks up to 35 weeks |
| Secondary | Overall Survival (OS) | Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact. | Analysis for this particular endpoint was not conducted due to lack of efficacy. | Posted | Median | 95% Confidence Interval | Days | Baseline to death due to any cause or at least every 3 months after discontinuation of study treatment |
|
|
| 9 |
| 12 |
| 12 |
| 12 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Ear disorder | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Carbon dioxide increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Carotid bruit | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 13.1 | 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.
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |