Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A4060010 |
Not provided
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The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
| |
| Cohort 3 | Experimental |
| |
| Cohort 4 | Experimental |
| |
| Cohort 5 | Experimental |
| |
| Cohort 6 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG-013736 | Drug | Axitinib continuous oral dosing (10 mg once a day, 10 mg twice a day, 20 mg twice a day or 30 mg twice day) in the fed state |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | MTD is defined as the dose level at which "no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD)." DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity. | Baseline up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours (hrs) post-dose on Day (D) 1 and 15 of Cycle (C) 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3) | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
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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 | San Francisco | California | 94115 | United States | ||
| Pfizer Investigational Site |
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 | Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed | Single dose of axitinib (AG-013736) 10 milligram (mg) tablet orally once daily (QD) followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally twice daily (BID) in fed state continuously in cycles of 4 weeks, up to 8 cycles. |
| FG001 | Cohort 2: Axitinib 20 mg BID, Fed | Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles. |
| FG002 | Cohort 3: Axitinib 5 mg BID, Fed | Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles. |
| FG003 | Cohort 4: Axitinib 15 mg QD, Fed | Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles. |
| FG004 | Cohort 5: Axitinib 5 mg BID, Fasted | Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles. |
| FG005 | Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted | Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed | Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles. |
| BG001 |
| 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 | Maximum Tolerated Dose (MTD) | MTD is defined as the dose level at which "no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD)." DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity. | Analysis population included all enrolled participants who received at least one dose of the study drug. | Posted | Number | mg BID | Baseline up to Day 28 |
|
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.
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 | All Treated Participants | All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v13.1 | 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 |
|---|---|
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AG-013736 | Drug | Axitinib continuous oral dosing (20 mg twice a day) in the fed state |
|
| AG-013736 | Drug | Axitinib continuous oral dosing (5 mg twice a day) in the fed state |
|
| AG-013736 | Drug | Axitinib continuous oral dosing (15 mg once a day) in the fed state |
|
| AG-013736 | Drug | Axitinib continuous oral dosing (5 mg twice a day) in the fasted state |
|
| AG-013736 | Drug | Axitinib continuous oral dosing (2 mg twice a day on the first day of dosing, followed by 5 mg twice a day) in the fasted state |
|
| Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3) |
| Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] | AUC (0-12)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12). | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3) |
| Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3) |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3) |
| Maximum Observed Plasma Concentration (Cmax) in Fed State Versus Overnight Fasting | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) in Fed State Versus Overnight Fasting | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2) |
| Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] in Fed State Versus Overnight Fasting | AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2) |
| Apparent Oral Clearance (CL/F) in Fed State Versus Overnight Fasting | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2) |
| Plasma Decay Half-Life (t1/2) in Fed State Versus Overnight Fasting | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2) |
| Houston |
| Texas |
| 77030 |
| United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53792 | United States |
| Progressive disease |
|
| Lack of Efficacy |
|
| Moved to rollover protocol |
|
| Other |
|
| Cohort 2: Axitinib 20 mg BID, Fed |
Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles. |
| BG002 | Cohort 3: Axitinib 5 mg BID, Fed | Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles. |
| BG003 | Cohort 4: Axitinib 15 mg QD, Fed | Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles. |
| BG004 | Cohort 5: Axitinib 5 mg BID, Fasted | Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles. |
| BG005 | Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted | Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles. |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Analysis population included all enrolled participants who received at least one dose of the study drug.'n' signifies those participants evaluated for this measure at specific time point for each cohort respectively. | Posted | Geometric Mean | Standard Deviation | Nanogram/milliliter (ng/mL) | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours (hrs) post-dose on Day (D) 1 and 15 of Cycle (C) 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3) |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Analysis population included all enrolled participants who received at least one dose of the study drug. 'n' signifies those participants evaluated for this measure at specific time point for each cohort respectively. | Posted | Median | Full Range | hr | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3) |
|
|
|
| Secondary | Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] | AUC (0-12)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12). | Analysis population included all enrolled participants who received at least one dose of the study drug. 'n' signifies those participants evaluated for this measure at specific time point for each cohort respectively. | Posted | Geometric Mean | 95% Confidence Interval | ng*hr/mL | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3) |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Analysis population included all enrolled participants who received at least one dose of the study drug. 'n' signifies those participants evaluated for this measure at specific time point for each cohort respectively. | Posted | Geometric Mean | 95% Confidence Interval | Liter/hr (L/hr) | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3) |
|
|
|
| Secondary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Analysis population included all enrolled participants who received at least one dose of the study drug. 'n' signifies those participants evaluated for this measure at specific time point for each cohort respectively. | Posted | Mean | Standard Deviation | hr | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3) |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) in Fed State Versus Overnight Fasting | The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose. | Posted | Geometric Mean | 90% Confidence Interval | ng/mL | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2) |
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) in Fed State Versus Overnight Fasting | The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose. | Posted | Mean | 90% Confidence Interval | hr | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2) |
|
|
| Secondary | Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] in Fed State Versus Overnight Fasting | AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). | The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose. | Posted | Geometric Mean | 90% Confidence Interval | ng*hr/mL | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2) |
|
|
| Secondary | Apparent Oral Clearance (CL/F) in Fed State Versus Overnight Fasting | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose. | Posted | Geometric Mean | 90% Confidence Interval | L/hr | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2) |
|
|
| Secondary | Plasma Decay Half-Life (t1/2) in Fed State Versus Overnight Fasting | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose. | Posted | Geometric Mean | 90% Confidence Interval | hr | Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2) |
|
|
| 12 |
| 36 |
| 36 |
| 36 |
| Pain | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v13.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v13.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v13.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v13.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v13.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v13.1 | 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.
| 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 |
| Day 15 (n= 6, 3, 5, 6, 6, 6) |
|
| Day 29 (n= 4, 3, 5, 5, 7, 6) |
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| Day 15 (n= 6, 3, 5, 6, 6, 6) |
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| Day 29 (n= 4, 3, 5, 5, 7, 6) |
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| Day 15 (n= 6, 3, 5, 6, 6, 6) |
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| Day 29 (n= 4, 3, 5, 5, 7, 6) |
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| Day 15 (n= 6, 3, 5, 6, 6, 6) |
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| Day 29 (n= 4, 2, 5, 5, 7, 6) |
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| Day 15 (n= 5, 3, 5, 4, 5, 6) |
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| Day 29 (n= 3, 2, 5, 3, 6, 6) |
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