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| ID | Type | Description | Link |
|---|---|---|---|
| SAD-MAD | Other Identifier | Alias Study Number |
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This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants received 1 single dose of placebo, PF-04958242 0.6 mg, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing. |
|
| Cohort 2 | Experimental | Participants received 1 single dose of PF-04958242 0.35 mg, placebo, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing. |
|
| Cohort 3 | Experimental | Participants received 1 single dose of PF-04958242 0.35 mg, PF-04958242 0.6 mg, and placebo orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04958242 | Drug | Administered as specified in treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). | Baseline up to Day 10 |
| 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 drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. | Baseline up to 28 days after last study drug administration. |
| Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (follicle stimulating hormone [FSH], and urine drug screening). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
Twelve participants were assigned study treatment. All participants received the assigned PF-04958242 doses during 3 periods (6 participants each received 0.35 mg, 0.6 mg and 0.8 mg doses, respectively). Nine participants received placebo. Three participants did not complete the study and they were replaced during the conduct of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, PF-04958242 0.6 Milligrams (mg), PF-04958242 0.8 mg | Participants received 1 single dose of placebo, PF-04958242 0.6 mg, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing. |
| FG001 | PF-04958242 0.35 mg, Placebo, PF-04958242 0.8 mg | Participants received 1 single dose of PF-04958242 0.35 mg, placebo, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing. |
| FG002 | PF-04958242 0.35 mg, PF-04958242 0.6 mg, Placebo | Participants received 1 single dose of PF-04958242 0.35 mg, PF-04958242 0.6 mg, and placebo orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
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| Washout Period (at Least 10 Days) |
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| Second Intervention Period |
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| Washout Period (at Least 10 Days) |
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| Third Intervention Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Included all participants who received at least 1 dose of study treatment in any of the intervention periods |
| 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 Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). | The safety analysis population included all participants who received the study medication. | Posted | Number | participants | Baseline up to Day 10 |
|
Baseline up to 28 days after last study drug administration.
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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 | PF-04958242 0.35 mg | All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
The participants received PF-04958242 0.35 milligrams (mg), 0.6 mg and 0.8 mg instead of the proposed doses of 0.35 mg, 0.55 mg and 0.75 mg based on the review conducted after each dosing period prior to proceeding to next dosing level.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
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| ID | Term |
|---|---|
| C000600968 | PF-04958242 |
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| Placebo | Drug | Administered as specified in treatment arm |
|
| Baseline up to Day 10 |
| Number of Participants With Potentially Clinically Significant Vital Signs Findings | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline. | Baseline up to Day 10 |
| Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB)and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported. | Baseline up to Day 10 |
| Number of Participants With Abnormal Physical Examination Findings | A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. | Baseline up to Day 10 |
| Number of Participants With Abnormal Neurological Examination Findings | The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA) | Baseline up to Day 10 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
| Apparent Clearance (CL/F) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
| Apparent Volume of Distribution (Vz/F) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
| Terminal Elimination Half-Life (t1/2) | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
| Dose Normalized Cmax (Cmax[dn]) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
| Dose Normalized AUClast (AUClast[dn]) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
| Dose Normalized AUCinf (AUCinf[dn]) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| PF-04958242 0.35 mg |
All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods. |
| OG001 | PF-04958242 0.6 mg | All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods. |
| OG002 | PF-04958242 0.8 mg | All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods. |
| OG003 | Placebo | All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods. |
|
|
| Primary | 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 drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. | The safety analysis population included all participants who received the study medication. | Posted | Number | participants | Baseline up to 28 days after last study drug administration. |
|
|
|
| Primary | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (follicle stimulating hormone [FSH], and urine drug screening). | The safety analysis population included all participants who received the study medication. | Posted | Number | participants | Baseline up to Day 10 |
|
|
|
| Primary | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline. | The safety analysis population included all participants who received the study medication. | Posted | Number | participants | Baseline up to Day 10 |
|
|
|
| Primary | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB)and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported. | The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria. | Posted | Number | participants | Baseline up to Day 10 |
|
|
|
| Primary | Number of Participants With Abnormal Physical Examination Findings | A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. | Posted | Number | participants | Baseline up to Day 10 |
|
|
|
| Primary | Number of Participants With Abnormal Neurological Examination Findings | The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA) | Posted | Number | participants | Baseline up to Day 10 |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) | The pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Median | Full Range | hours | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
|
|
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (ng*h/mL) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
|
|
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
|
|
| Secondary | Apparent Clearance (CL/F) | The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliters per minute (mL/min) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/F) | The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
|
|
| Secondary | Terminal Elimination Half-Life (t1/2) | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. | The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Mean | Standard Deviation | hours | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
|
|
| Secondary | Dose Normalized Cmax (Cmax[dn]) | The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/mL/mg | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
|
|
| Secondary | Dose Normalized AUClast (AUClast[dn]) | The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL/mg | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
|
|
| Secondary | Dose Normalized AUCinf (AUCinf[dn]) | The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL/mg | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | PF-04958242 0.6 mg | All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods. | 0 | 6 | 4 | 6 |
| EG002 | PF-04958242 0.8 mg | All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods. | 0 | 6 | 2 | 6 |
| EG003 | Placebo | All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods. | 0 | 9 | 4 | 9 |
| Vertigo | Ear and labyrinth disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Penis disorder | Reproductive system and breast disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.1 | 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.
| SAEs |
|
| Standing SBP <90 mm Hg |
|
| Supine DBP <50 mm Hg |
|
| Standing DBP <50 mm Hg |
|
| Supine Pulse Rate <40 bpm |
|
| Supine Pulse >120 bpm |
|
| Standing Pulse Rate <40 bpm |
|
| Standing Pulse Rate >140 bpm |
|
| Supine SBP >=30 mm Hg IFB |
|
| Standing SBP >=30 mm Hg IFB |
|
| Supine DBP >=20 mm Hg IFB |
|
| Standing DBP >=20 mm Hg IFB |
|
| Supine SBP >=30 mm Hg DFB |
|
| Standing SBP >=30 mm Hg DFB |
|
| Supine DBP >=20 mm Hg DFB |
|
| Standing DBP >=20 mm Hg DFB |
|
| QRS Complex >=140 msec |
|
| QTcF Interval 450-<480 msec |
|
| QTcF Interval 480-<500 msec |
|
| QTcF Interval >=500 msec |
|
| QTcB Interval >=500 msec |
|
| PR Interval >=25/50% IFB |
|
| QRS Interval >=50% IFB |
|
| QTcF Interval 30-<60 msec IFB |
|
| QTcF Interval >=60 msec IFB |
|