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The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-fluorouracil | Drug | 5- fluorouracil is given as 4000 mg/m^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) | The incidence of DLTs assessed during the first cycle (21 days). | Cycle 1 (Baseline to Day 21) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose) | |
| Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)] | Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24). |
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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 | Barcelona | Barcelona | 08003 | Spain | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib (25 mg) in Combination With Cisplatin and 5-FU | Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle. |
| FG001 | Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU | Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib (25 mg) in Combination With Cisplatin and 5-FU | Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle. |
| 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 | Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) | The incidence of DLTs assessed during the first cycle (21 days). | Safety: enrolled participants who received at least 1 dose of study drug. | Posted | Number | Participants | Cycle 1 (Baseline to Day 21) |
|
Not provided
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib (25 mg) in Combination With Cisplatin and 5-FU | Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | 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 |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D002945 | Cisplatin |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| cisplatin | Drug | Cisplatin is given 80 mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. |
|
| sunitinib malate | Drug | sunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. |
|
| Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax). | Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose) |
| Steady State Concentration (Css) of 5-Fluorouracil (5-FU) | Steady state plasma concentration of 5-FU equals AUC(2-6) divided by 4, where AUC(2-6) is the area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6). | Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) |
| Infusion Rate (Zero Order) (R0) of 5-FU | Infusion rate of 5-FU equals total dose divided by infusion time. | Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) |
| Clearance (CLss) of 5-FU | Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css). | Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) |
| Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU | Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6). | Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) |
| Number of Participants With Objective Response | Number of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | Baseline, Day 21 of every even-numbered cycle up to 15 Months |
| Duration of Response (DR) | Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to any cause, whichever occurrs first. DR calculated as (Months) equals (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 30. | Baseline up to Month 15 |
| Progression-Free Survival (PFS) | Median time (50%) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Months) equals (first event date minus first dose date plus 1) divided by 30. | Baseline up to Month 15 |
| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28041 | Spain |
| Objective progression or relapse |
|
| Other |
|
| Participant refused |
|
| BG001 | Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU | Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle. |
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Pharmacokinetic (PK): participants who received Sunitinib and had sufficient plasma concentration data for calculation of PK parameters; N=number of participants contributing to summary statistics. Cmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at maximum tolerated dose. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose) |
|
|
|
| Secondary | Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)] | Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24). | PK; N=the number of participants contributing to the summary statistics. AUC(0-24) of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at the maximum tolerated dose (MTD; 25 mg Sunitinib). | Posted | Mean | Standard Deviation | ng*h/mL | Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose) |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax). | PK; N=the number of participants contributing to the summary statistics. Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib). | Posted | Median | Full Range | hours | Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose) |
|
|
|
| Secondary | Steady State Concentration (Css) of 5-Fluorouracil (5-FU) | Steady state plasma concentration of 5-FU equals AUC(2-6) divided by 4, where AUC(2-6) is the area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6). | PK; N=number of participants contributing to the summary statistics. Css calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib). | Posted | Mean | Standard Deviation | ng/mL | Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) |
|
|
|
| Secondary | Infusion Rate (Zero Order) (R0) of 5-FU | Infusion rate of 5-FU equals total dose divided by infusion time. | PK; N= number of participants contributing to the summary statistics. R0 calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib). | Posted | Mean | Standard Deviation | mg/hr | Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) |
|
|
|
| Secondary | Clearance (CLss) of 5-FU | Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css). | PK; N=the number of participants contributing to the summary statistics. CLss calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib). | Posted | Mean | Standard Deviation | Liters per hour | Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) |
|
|
|
| Secondary | Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU | Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6). | PK; N=number of participants contributing to the summary statistics. Css calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib). | Posted | Mean | Standard Deviation | ng*h/mL | Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) |
|
|
|
| Secondary | Number of Participants With Objective Response | Number of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | Efficacy: all participants enrolled in the study who received at least 1 dose of study medication. N=number of participants with measurable disease at baseline. | Posted | Number | Participants | Baseline, Day 21 of every even-numbered cycle up to 15 Months |
|
|
|
|
| Secondary | Duration of Response (DR) | Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to any cause, whichever occurrs first. DR calculated as (Months) equals (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 30. | Efficacy; N=number of participants with objective response. | Posted | Mean | Standard Deviation | Months | Baseline up to Month 15 |
|
|
|
| Secondary | Progression-Free Survival (PFS) | Median time (50%) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Months) equals (first event date minus first dose date plus 1) divided by 30. | Efficacy | Posted | Median | 95% Confidence Interval | Months | Baseline up to Month 15 |
|
|
|
| 7 |
| 24 |
| 24 |
| 24 |
| EG001 | Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU | Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle. | 5 | 10 | 10 | 10 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Aerophagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anal pruritus | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Renal artery thrombosis | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Skin depigmentation | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Aortic thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Iliac artery thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vena cava thrombosis | Vascular disorders | MedDRA 13.0 | 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.
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006571 |
| Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|