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The purposes of this study are:
This study is seeking for participants who:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo. |
|
| Cohort 2 | Experimental | Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo. |
|
| Cohort 3 | Experimental | Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07853578 | Drug | PF-07853578 will be administered as oral solutions or suspensions as escalating single doses to be determined. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (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. | Day 1-11 in each period, along with the 29-36 day post final dose follow-up |
| Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality | Pre-defined categorical criteria for laboratory abnormalities included: Lymphocytes <0.8 x lower limit of normal (LLN); Basophils/Leukocytes > 1.2 x upper limit of normal (ULN); Eosinophils/Leukocytes >1.2 x ULN; Monocytes/Leukocytes >1.2 x ULN; low-density lipoprotein (LDL) Direct Endpoint Measure >1.2 x ULN; Triglycerides >1.3 x ULN; Specific Gravity <1.003 or >1.030; pH >8; Ketones ≥1; Urobilinogen (EU) ≥1; URINE Bilirubin ≥1; Leukocyte Esterase ≥1. | Day 1-11 in each period, along with the 29-36 day post final dose follow-up |
| Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria | Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration Observed in Plasma (Cmax) | Maximum observed plasma PF-07328948 concentration. Observed directly from data. | Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4) |
| Time to Achieve Cmax (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention, with the exception of moderate or strong cytochrome P450 3A (CYP3A) inducers or inhibitors which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest.
Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73m².
Hematuria as defined by >1+ heme on urine dipstick.
Albuminuria as defined by albumin/creatine (Cr) ratio on spot urine albumin (UA) >30 mg/g.
Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States | ||
| Pfizer Clinical Research Unit - New Haven |
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| 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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A total of 23 participants were enrolled, and received at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Cohort 1 included 4 sequences, each sequence of which included 4 treatment periods: Placebo Fasted->PF-07853578 10 mg [10 mg]->100 mg->500 mg; 1 mg (low dosage strength [LDS])->Placebo Fasted->100 mg->500 mg; 1 mg (LDS)->10 mg->Placebo Fasted->500 mg; and 1 mg (LDS)->10 mg->100 mg->Placebo Fasted |
| FG001 | Cohort 2 | Cohort 2 included 4 sequences, each sequence of which included 4 treatment periods: Placebo Fasted->30 mg->300 mg->300 mg Fed; 3 mg->Placebo Fasted->300 mg->300 mg fed; 3 mg->30 mg->Placebo Fasted->Placebo Fed; and 3 mg->30 mg->300 mg->300 mg fed |
| FG002 | Cohort 3 | Cohort 3 included 2 sequences, each sequence of which included 2 treatment periods: Placebo Fasted->Placebo Fasted; and 8 mg->8 mg (intermediate dosage strength [IDS]) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Cohort 1 included 4 sequences, each sequence of which included 4 treatment periods: Placebo Fasted->PF-07853578 10 mg [10 mg]->100 mg->500 mg; 1 mg (low dosage strength [LDS])->Placebo Fasted->100 mg->500 mg; 1 mg (LDS)->10 mg->Placebo Fasted->500 mg; and 1 mg (LDS)->10 mg->100 mg->Placebo Fasted |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 Reporting Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (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. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1-11 in each period, along with the 29-36 day post final dose follow-up |
Day 1-11 in each period, along with the 29-36 day post final dose follow-up
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 participant and as non-serious in another participant, or one 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 | PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution) | Participants in Cohort 1 received 1 mg (LDS Solution). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoacusis | Ear and labyrinth disorders | MedDRA v26.1 | Non-systematic Assessment |
Any untoward findings identified on physical and/or neurological examinations, and cardiac monitoring conducted during the active collection period were captured as adverse events, if those findings met the definition of an AE.
| 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 | Jun 6, 2023 | Nov 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2023 | Nov 7, 2024 | SAP_001.pdf |
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| Placebo | Drug | Placebo will be administered as oral solutions or suspensions as escalating single doses to be determined. |
|
| Day 1-11 in each period, along with the 29-36 day post final dose follow-up |
| Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria | ECG categorical criteria: 1. 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): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is > 200 msec, c) ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and ≤480 msec, b) >480 msec and ≤500 msec, c) >500 msec, d) >30 msec and ≤60 msec increase from baseline, e) >60 msec increase from baseline. | Day 1-11 in each period, along with the 29-36 day post final dose follow-up |
Observed directly from data as time of first occurrence. |
| Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measured Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration. It was determined by using linear/Log trapezoidal method. | Pre-dose (0 hours) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | Area under the plasma concentration-time curve from time 0 extrapolated to infinite time. AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis, and Kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, AUClast = Area under the plasma concentration time-curve from zero to the last measured concentration. | Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4) |
| Terminal Half-Life (t1/2) | Terminal elimination half-life. t1/2 = Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. | Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4) |
| New Haven |
| Connecticut |
| 06511 |
| United States |
| Cohort 2 |
Cohort 2 included 4 sequences, each sequence of which included 4 treatment periods: Placebo Fasted->30 mg->300 mg->300 mg Fed; 3 mg->Placebo Fasted->300 mg->300 mg fed; 3 mg->30 mg->Placebo Fasted->Placebo Fed; and 3 mg->30 mg->300 mg->300 mg fed |
| BG002 | Cohort 3 | Cohort 3 included 2 sequences, each sequence of which included 2 treatment periods: Placebo Fasted->Placebo Fasted; and 8 mg->8 mg (intermediate dosage strength [IDS]) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Primary | Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality | Pre-defined categorical criteria for laboratory abnormalities included: Lymphocytes <0.8 x lower limit of normal (LLN); Basophils/Leukocytes > 1.2 x upper limit of normal (ULN); Eosinophils/Leukocytes >1.2 x ULN; Monocytes/Leukocytes >1.2 x ULN; low-density lipoprotein (LDL) Direct Endpoint Measure >1.2 x ULN; Triglycerides >1.3 x ULN; Specific Gravity <1.003 or >1.030; pH >8; Ketones ≥1; Urobilinogen (EU) ≥1; URINE Bilirubin ≥1; Leukocyte Esterase ≥1. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1-11 in each period, along with the 29-36 day post final dose follow-up |
|
|
|
| Primary | Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria | Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1-11 in each period, along with the 29-36 day post final dose follow-up |
|
|
|
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria | ECG categorical criteria: 1. 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): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is > 200 msec, c) ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and ≤480 msec, b) >480 msec and ≤500 msec, c) >500 msec, d) >30 msec and ≤60 msec increase from baseline, e) >60 msec increase from baseline. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1-11 in each period, along with the 29-36 day post final dose follow-up |
|
|
|
| Secondary | Maximum Concentration Observed in Plasma (Cmax) | Maximum observed plasma PF-07328948 concentration. Observed directly from data. | All participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4) |
|
|
|
| Secondary | Time to Achieve Cmax (Tmax) | Observed directly from data as time of first occurrence. | All participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. | Posted | Median | Full Range | hours (hr) | Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4) |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measured Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration. It was determined by using linear/Log trapezoidal method. | All participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Pre-dose (0 hours) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4) |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | Area under the plasma concentration-time curve from time 0 extrapolated to infinite time. AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis, and Kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, AUClast = Area under the plasma concentration time-curve from zero to the last measured concentration. | All participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4) |
|
|
|
| Secondary | Terminal Half-Life (t1/2) | Terminal elimination half-life. t1/2 = Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. | All participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. | Posted | Mean | Standard Deviation | hours (hr) | Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | 3 mg | Participants in Cohort 2 received 3 mg. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | 8 mg | Participants in Cohort 3 received 8 mg. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG003 | 8 mg (Intermediate Dosage Strength [IDS] Solution) | Participants in Cohort 3 received 8 mg (IDS Solution) | 0 | 5 | 0 | 5 | 2 | 5 |
| EG004 | 10 mg | Participants in Cohort 1 received 10 mg. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG005 | 30 mg | Participants in Cohort 2 received 30 mg. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | 100 mg | Participant in Cohort 1 received 100 mg. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG007 | 300 mg | Participants in Cohort 2 received 300 mg. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG008 | 300 mg Fed | Participants in Cohort 2 received 300 mg Fed. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG009 | 500 mg | Participants in Cohort 1 received 500 mg. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG010 | Placebo Fasted | Participants in Cohorts 1, 2, and 3 received Placebo Fasted. | 0 | 14 | 0 | 14 | 3 | 14 |
| EG011 | Placebo Fed | Participants in Cohort 2 received Placebo Fed. | 0 | 1 | 0 | 1 | 0 | 1 |
| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
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| Pulse rate < 40 bpm |
|
| Pulse rate > 120 bpm |
|
| SBP <90 mmHg |
|
| Change from baseline in DBP ≥20 increase |
|
| Change from baseline in DBP ≥20 decrease |
|
| Change from baseline in SBP ≥30 mmHg increase |
|
| Change from baseline in SBP ≥30 mmHg decrease |
|