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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban 5mg BID | Experimental |
| |
| Apixaban 2.5mg BID | Experimental |
| |
| Warfarin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Apixaban 5 mg tablet BID for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period | Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Total Bleeding Events During the Treatment Period | Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban | Sample at 4 hours postdose was to be taken if possible. | 0, 2, 4 hours postdose at Week 1 and Week 8 |
| Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban |
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 | Nagoya | Aichi-ken | Japan | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21670542 | Derived | Ogawa S, Shinohara Y, Kanmuri K. Safety and efficacy of the oral direct factor xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. -The ARISTOTLE-J study-. Circ J. 2011;75(8):1852-9. doi: 10.1253/circj.cj-10-1183. Epub 2011 Jun 14. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Warfarin | The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks. |
| FG001 | Apixaban 2.5mg BID | One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. |
| FG002 | Apixaban 5.0 mg BID | One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Warfarin | The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks. |
| 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 | Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period | Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. | The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan. | Posted | Number | participants | Baseline to Week 12 |
|
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 | Warfarin | The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | 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 |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| C522181 | apixaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Apixaban |
| Drug |
Apixaban 2.5 mg tablet BID for 12 weeks |
|
| Warfarin sodium | Drug | At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks |
|
| Baseline to Week 12 |
| Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period | Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event. | Baseline to Week 12 |
| Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period | Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. | Baseline to Week 12 |
| Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period | The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day. | Baseline to Week 12 |
| Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period | The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day. | Baseline to Week 12 |
| Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period | The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day. | Baseline to Week 12 |
Sample at 4 hours postdose was to be taken if possible. |
| Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 |
| Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban | Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists. | Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 |
| Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban | Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. | Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 |
| Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban | Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated. | Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 |
| Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban | Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated. | Week 0, Week 1, Week 8 |
| Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban | Below the limit of quantification (BLQ) was assigned the value 0 for calculation. | Week 0, Week 1, Week 8 |
| Seto |
| Aichi-ken |
| Japan |
| Pfizer Investigational Site | Touon | Ehime | Japan |
| Pfizer Investigational Site | Fukuoka | Fukuoka | Japan |
| Pfizer Investigational Site | Kitakyushu | Fukuoka | Japan |
| Pfizer Investigational Site | Ōgaki | Gifu | Japan |
| Pfizer Investigational Site | Isesaki | Gunma | Japan |
| Pfizer Investigational Site | Shibukawa | Gunma | Japan |
| Pfizer Investigational Site | Sapporo | Hokkaido | Japan |
| Pfizer Investigational Site | Higashiibaraki-gunn Ibarakimachi | Ibaraki | Japan |
| Pfizer Investigational Site | Zentsujichó | Kagawa-ken | Japan |
| Pfizer Investigational Site | Kawasaki | Kanagawa | Japan |
| Pfizer Investigational Site | Kumamoto | Kumamoto | Japan |
| Pfizer Investigational Site | Tsu | Mie-ken | Japan |
| Pfizer Investigational Site | Minato-ku | Tokyo | Japan |
| Pfizer Investigational Site | Shinagawa-ku | Tokyo | Japan |
| Pfizer Investigational Site | Shinjuku-ku | Tokyo | Japan |
| Pfizer Investigational Site | Iwakuni | Yamaguchi | Japan |
| Withdrawal by Subject |
|
| Dosing incorrect study durg |
|
| Apixaban 2.5mg BID |
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. |
| BG002 | Apixaban 5.0 mg BID | One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Warfarin | The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks. |
| OG001 | Apixaban 2.5mg BID | One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. |
| OG002 | Apixaban 5.0 mg BID | One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. |
|
|
| Secondary | Number of Participants With Total Bleeding Events During the Treatment Period | Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding. | The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan. | Posted | Number | participants | Baseline to Week 12 |
|
|
|
| Secondary | Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period | Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event. | The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan. | Posted | Number | participants | Baseline to Week 12 |
|
|
|
| Secondary | Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period | Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. | The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan. | Posted | Number | participants | Baseline to Week 12 |
|
|
|
| Secondary | Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period | The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day. | Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received. | Posted | Number | participants | Baseline to Week 12 |
|
|
|
| Secondary | Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period | The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day. | Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received. | Posted | Number | participants | Baseline to Week 12 |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period | The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day. | Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received. | Posted | Number | participants | Baseline to Week 12 |
|
|
|
| Other Pre-specified | Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban | Sample at 4 hours postdose was to be taken if possible. | The pharmacokinetic analysis set was defined as participants treated with apixaban, who were not assessed as major protocol violators, and in whom at least one observation of plasma apixaban concentration. n=number of participants with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively. | Posted | Mean | Standard Deviation | ng/mL | 0, 2, 4 hours postdose at Week 1 and Week 8 |
|
|
|
| Other Pre-specified | Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban | Sample at 4 hours postdose was to be taken if possible. | The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively. | Posted | Mean | Standard Deviation | second | Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 |
|
|
|
| Other Pre-specified | Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban | Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists. | The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively. | Posted | Mean | Standard Deviation | International normalized ratio | Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 |
|
|
|
| Other Pre-specified | Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban | Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. | The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively. | Posted | Mean | Standard Deviation | Second | Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 |
|
|
|
| Other Pre-specified | Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban | Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated. | The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively. | Posted | Mean | Standard Deviation | ng/mL | Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 |
|
|
|
| Other Pre-specified | Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban | Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated. | The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively. | Posted | Mean | Standard Deviation | pmol/L | Week 0, Week 1, Week 8 |
|
|
|
| Other Pre-specified | Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban | Below the limit of quantification (BLQ) was assigned the value 0 for calculation. | The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of participants with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively. | Posted | Mean | Standard Deviation | ng/mL | Week 0, Week 1, Week 8 |
|
|
|
| 4 |
| 75 |
| 17 |
| 75 |
| EG001 | Apixaban 2.5mg BID | One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. | 1 | 72 | 24 | 72 |
| EG002 | Apixaban 5.0 mg BID | One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. | 5 | 71 | 22 | 71 |
| Overdose | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arterial stenosis limb | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatine phophkinase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA 12.0 | 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.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 4 hours post dose at Week 1 (n=38, 35) |
|
| 0 hour post dose at Week 8 (n=67, 66) |
|
| 2 hours post dose at Week 8 (n=67, 66) |
|
| 4 hours post dose at Week 8 (n=35, 29) |
|
| 2 hours post dose at Week 1 (n=68, 70) |
|
| 4 hours post dose at Week 1 (n=38, 35) |
|
| 0 hour post dose at Week 8 (n=67, 66) |
|
| 2 hours post dose at Week 8 (n=67, 66) |
|
| 4 hours post dose at Week 8 (n=35, 29) |
|
| 2 hours post dose at Week 1 (n=68, 70) |
|
| 4 hours post dose at Week 1 (n=38, 35) |
|
| 0 hour post dose at Week 8 (n=67, 66) |
|
| 2 hours post dose at Week 8 (n=67, 66) |
|
| 4 hours post dose at Week 8 (n=35, 29) |
|
| 2 hours post dose at Week 1 (n=68, 70) |
|
| 4 hours oist dose at Week 1 (n=38, 35) |
|
| 0 hour post dose at Week 8 (n=67, 66) |
|
| 2 hours post dose at Week 8 (n=67, 66) |
|
| 4 hours post dose at Week 8 (n=35, 29) |
|
| 2 hours post dose at Week 1 (n=68, 70) |
|
| 4 hours post dose at Week 1 (n=38, 35) |
|
| 0 hour post dose at Week 8 (n=67, 65) |
|
| 2 hours post dose at Week 8 (n=67, 66) |
|
| 4 hours post dose at Week 8 (n=35, 29) |
|
|
| Week 8 (n=68, 67, 66) |
|
|
| Week 8 (n=68, 67, 66) |
|