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2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PF-06865571 100 mg | Experimental |
| |
| PF-06865571 600 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | tablet, 0 mg, 14 days, every 12 hours |
| |
| PF-06865571 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF) | MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level. | Baseline (Day 1), Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration. AEs included both SAEs and non-serious AEs. |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| New Haven Clinical Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36690550 | Derived | Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days. |
| FG001 | PF-06865571 50 mg | Participants received PF-06865571 50 mg tablets orally Q12H for 14 days. |
| FG002 | PF-06865571 300 mg | Participants received PF-06865571 300 mg tablets orally Q12H for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days. |
| BG001 | PF-06865571 50 mg | Participants received PF-06865571 50 mg tablets orally Q12H for 14 days. |
| 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 | Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF) | MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level. | All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo) and had whole liver fat assessed at Day 15. | Posted | Least Squares Mean | 80% Confidence Interval | percentage of whole liver fat | Baseline (Day 1), Day 15 |
|
From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA v22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2018 | Feb 28, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2018 | Feb 28, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000726790 | ervogastat |
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| Drug |
tablet, 50 mg, 14 days, every 12 hours |
|
| PF-06865571 | Drug | tablet, 300 mg, 14 days, every 12 hours |
|
| From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) |
| Number of Participants With Laboratory Test Abnormalities | Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, sodium, potassium, calcium, chloride, bicarbonate); urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, urine erythrocytes, urine leukocytes, hyaline casts); biomarker (total cholesterol, low-density and high-density lipoprotein cholesterol, triglycerides, fasting glucose). Participants with any of the laboratory test abnormalities were counted. | From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days) |
| Number of Participants With Vital Sign Abnormalities | Vital sign categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in supine SBP >=30 mmHg. | From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days) |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (heart rate corrected QT [time between the start of the ECG Q wave and the end of the T wave in the heart's electrical cycle] using Fridericia's formula): absolute value of >450 to 480 msec, >480 to 500 msec, >500 msec; a change from baseline of >30 to 60 msec or >60 msec. | From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days) |
| Maximum Plasma Concentration (Cmax) For PF-06865571 | Cmax of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages. | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
| Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCtau) For PF-06865571 | AUCtau of PF-06865571 on Day 14 was obtained by linear/log trapezoidal method. The dosing interval (tau) was 12 hours. Geometric coefficients of variations were reported as percentages. | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
| Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571 | Tmax of PF-06865571 on Day 14 was observed directly from data as time of Cmax occurrence. | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
| Minimum Plasma Concentration (Cmin) For PF-06865571 | Cmin of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages. | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
| Apparent Oral Clearance (CL/F) For PF-06865571 | CL/F of PF-06865571 on Day 14 was calculated as Dose/AUCtau. Geometric coefficients of variations were reported as percentages. | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
| Peak-to-Trough Ratio (PTR) For PF-06865571 | PTR of PF-06865571 on Day 14 was calculated as Cmax/Cmin. Geometric coefficients of variations were reported as percentages. | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
| New Haven |
| Connecticut |
| 06511 |
| United States |
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
| PPD Development, LP | Las Vegas | Nevada | 89113 | United States |
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Death |
|
| BG002 | PF-06865571 300 mg | Participants received PF-06865571 300 mg tablets orally Q12H for 14 days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| PF-06865571 50 mg |
Participants received PF-06865571 50 mg tablets orally Q12H for 14 days. |
| OG002 | PF-06865571 300 mg | Participants received PF-06865571 300 mg tablets orally Q12H for 14 days. |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration. AEs included both SAEs and non-serious AEs. | All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo). | Posted | Count of Participants | Participants | From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormalities | Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, sodium, potassium, calcium, chloride, bicarbonate); urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, urine erythrocytes, urine leukocytes, hyaline casts); biomarker (total cholesterol, low-density and high-density lipoprotein cholesterol, triglycerides, fasting glucose). Participants with any of the laboratory test abnormalities were counted. | All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo). | Posted | Count of Participants | Participants | From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days) |
|
|
|
| Secondary | Number of Participants With Vital Sign Abnormalities | Vital sign categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in supine SBP >=30 mmHg. | All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo). | Posted | Count of Participants | Participants | From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days) |
|
|
|
| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (heart rate corrected QT [time between the start of the ECG Q wave and the end of the T wave in the heart's electrical cycle] using Fridericia's formula): absolute value of >450 to 480 msec, >480 to 500 msec, >500 msec; a change from baseline of >30 to 60 msec or >60 msec. | All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo). | Posted | Count of Participants | Participants | From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days) |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) For PF-06865571 | Cmax of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages. | All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCtau) For PF-06865571 | AUCtau of PF-06865571 on Day 14 was obtained by linear/log trapezoidal method. The dosing interval (tau) was 12 hours. Geometric coefficients of variations were reported as percentages. | All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had AUCtau data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*hr/mL) | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571 | Tmax of PF-06865571 on Day 14 was observed directly from data as time of Cmax occurrence. | All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Tmax data. | Posted | Median | Full Range | hours | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
|
|
|
| Secondary | Minimum Plasma Concentration (Cmin) For PF-06865571 | Cmin of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages. | All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Cmin data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) For PF-06865571 | CL/F of PF-06865571 on Day 14 was calculated as Dose/AUCtau. Geometric coefficients of variations were reported as percentages. | All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had CL/F data. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per hour (L/hr) | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
|
|
|
| Secondary | Peak-to-Trough Ratio (PTR) For PF-06865571 | PTR of PF-06865571 on Day 14 was calculated as Cmax/Cmin. Geometric coefficients of variations were reported as percentages. | All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Cmax and non-zero Cmin data for PTR evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio of concentrations | Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | PF-06865571 50 mg | Participants received PF-06865571 50 mg tablets orally Q12H for 14 days. | 0 | 17 | 0 | 17 | 12 | 17 |
| EG002 | PF-06865571 300 mg | Participants received PF-06865571 300 mg tablets orally Q12H for 14 days. | 1 | 15 | 1 | 15 | 8 | 15 |
| Constipation | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Excessive cerumen production | Ear and labyrinth disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
|
|
| Supine SBP decrease >=30 mm Hg |
|
| Supine DBP <50 mmHg |
|
| Supine DBP increase >=20 mm Hg |
|
| Supine DBP decrease >=20 mm Hg |
|
| Pulse rate <40 bpm |
|
| Pulse rate >120 bpm |
|
|
| QRS interval >=140 msec |
|
| %Change in QRS interval >=50% |
|
| QTcF >450 to <=480 msec |
|
| QTcF >480 to <=500 msec |
|
| QTcF >500 msec |
|
| QTcF change >30 to <=60 msec |
|
| QTcF change >60 msec |
|