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The purpose of this study is to learn how Itraconazole affects the blood level of PF-07817883 in Healthy Adults.
This study is seeking participants who are:
This study will consist of 2 parts, Period 1 and Period 2.
Period 1: participants will take PF-07817883 one time by mouth at the study clinic.
Period 2: participants will take PF-07817883 one time by mouth at the study clinic. They will also take daily itraconazole by mouth for 7 days.
Participants will stay at the study clinic for 2 weeks in total. The study doctors will collect blood and urine samples from everyone. The study doctors will check participants' reactions to the study medicine for safety measures. There is a follow-up call at 28 to 35 days from the last dose of PF-07817883.
Itraconazole is an approved medicine. It is also a metabolism inhibitor. When taken with some medicines, it affects the actual level of these medicines in the body. This study will compare blood levels of PF-07817883 given with and without Itraconazole. This will help decide safety and right amount for PF-07817883 when given with metabolism inhibitors.
This is a Phase 1, open-label, 2-period, fixed sequence study to estimate the effect of itraconazole, a strong CYP3A4 inhibitor, on the plasma PK of PF-07817883 in healthy adults. The study will consist of 2 treatments: a single oral dose of PF-07817883 alone and a single oral dose of PF-07817883 in combination with multiple oral doses of itraconazole. The PK and safety will be assessed and compared for single dose of PF-07817883 in period 1 and period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | The treatment arm includes a single dose of PF-07817883 (Period 1 Day 1) |
|
| Period 2 | Experimental | This treatment arm includes 7-day dosing of itraconazole with a single dose of PF-07817883 Co-administered on Day 4 (Period 2 Day 4) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07817883 | Drug | Single oral dose (period 1) or co-administered with itraconazole (period 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of PF-07817883 | Cmax was observed directly from data and measured in nanogram per milliliter (ng/mL). | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
| Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883 | AUCinf was derived by AUClast + (Clast*/kel). AUClast was area under the plasma concentration-time profile from time 0 to the time of Clast; Clast* was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUCinf was measured in nanogram*hour per milliliter (ng*hr/mL). | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs were events that occurred between first dose of study intervention and up to maximum of 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
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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 |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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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 12 participants were enrolled in the study. Study had 2 treatment periods with fixed sequence.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-07817883 | Participants received PF-07817883 300 milligrams (mg) as a single oral dose on Day 1 of Period 1. |
| FG001 | PF-07817883 + Itraconazole | Participants received itraconazole 200 mg orally once in a day (QD) from Day 1 to Day 7 of Period 2. On Day 4 of Period 2, participants received PF-07817883 300 mg as a single oral dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (5 Days) |
| |||||||||||||
| Treatment Period 2 (8 Days) |
|
All participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who received PF-07817883 300 mg orally on Day 1 of Period 1 and on Day 4 of Period 2 along with itraconazole 200 mg QD orally from Day 1 to Day 7 of Period 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) of PF-07817883 | Cmax was observed directly from data and measured in nanogram per milliliter (ng/mL). | Pharmacokinetic (PK) parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
|
Day 1 up to 35 days after last dose of study drug (maximum up to 48 days)
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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-07817883 | Participants received PF-07817883 300 milligrams (mg) as a single oral dose on Day 1 of Period 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@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 | Apr 19, 2023 | Jul 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2023 | Jul 2, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Masking: None (open label)
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| Itraconazole | Drug | Interacting drug which will be given for 7 days in period 2 |
|
|
| Day 1 of dosing up to 35 days post last dose of study intervention (maximum up to 48 days) |
| Number of Participants With Laboratory Test Abnormalities | Laboratory assessments included: hematology assessments included monocytes/leukocytes (percentage [%]) greater than (>) 1.2*upper limit of normal (ULN), urinalysis assessments included urine hemoglobin greater than or equal to (>=) 1, low power field (LPF), urine bacteria >20/LPF. | Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days) |
| Number of Participants With Electrocardiogram (ECG) Findings Per Pre-defined Criteria | Standard 12-lead ECGs was collected using an ECG system that automatically calculates the heart rate (HR) and measures PR interval, QT interval, QTcF, and QRS interval. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. To ensure safety of the participants, a qualified individual at the investigator site made comparisons to baseline measurements. Pre-defined criteria was defined as 30 milliseconds (ms) less than (<) change less than or equal to (<=) 60 ms. | Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days) |
| Number of Participants With Vital Signs Findings Per Pre-defined Criteria | Vital signs included: supine diastolic blood pressure (DBP) measured in millimetre of mercury (mmHg) with criteria value as follows- Value <50 mmHg, change>= 20 mmHg increase, change >= 20 mmHg decrease; supine pulse rate (PR) measured in beats per minute (bpm) with criteria values as follows- value < 40 bpm, value > 120 bpm; supine systolic blood pressure (SBP, mmHg) with criteria values as follows- value< 90 mmHg, change >= 30 mmHg increase, change >=30 mmHg decrease. Vital signs (SBP BP, and pulse rate) were measured with participants after having a rest for at least 5 minutes in a supine position. Supine BP was measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest. If timing of these measurements coincided with a blood collection, BP and PR were obtained prior to nominal time of blood collection. Only participants having at least 1 vital sign findings per pre-defined criteria are reported. | Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days) |
| Number of Participants With Clinically Significant Abnormalities in Physical Examination | A complete physical examination included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included, at a minimum, assessments of general appearance, the respiratory and CV systems, and participant-reported symptoms. Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. Clinical significance of physical examination abnormalities was judged by physicians. | Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days) |
| Time to Reach Cmax (Tmax) of PF-07817883 | Tmax is the time taken (in hours) to reach the maximum serum drug concentration. Tmax was observed directly from data as time of first occurrence. | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
| Terminal Phase Half-Life (t1/2) of PF-07817883 | Terminal half-life was defined as the time measured for the plasma concentration of drug to decrease by one half. t1/2 was determined by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
| Apparent Clearance (CL/F) of PF-07817883 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose administered divided by area under the concentration curve from time 0 extrapolated to infinite time (AUCinf). | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
| Apparent Volume of Distribution (Vz/F) of PF-07817883 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received itraconazole 200 mg orally once in a day (QD) from Day 1 to Day 7 of Period 2. On Day 4 of Period 2, participants received PF-07817883 300 mg as a single oral dose. |
|
|
|
| Primary | Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883 | AUCinf was derived by AUClast + (Clast*/kel). AUClast was area under the plasma concentration-time profile from time 0 to the time of Clast; Clast* was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUCinf was measured in nanogram*hour per milliliter (ng*hr/mL). | PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
|
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs were events that occurred between first dose of study intervention and up to maximum of 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants enrolled and took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to 35 days post last dose of study intervention (maximum up to 48 days) |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormalities | Laboratory assessments included: hematology assessments included monocytes/leukocytes (percentage [%]) greater than (>) 1.2*upper limit of normal (ULN), urinalysis assessments included urine hemoglobin greater than or equal to (>=) 1, low power field (LPF), urine bacteria >20/LPF. | Safety analysis set included all participants enrolled and took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days) |
|
|
|
| Secondary | Number of Participants With Electrocardiogram (ECG) Findings Per Pre-defined Criteria | Standard 12-lead ECGs was collected using an ECG system that automatically calculates the heart rate (HR) and measures PR interval, QT interval, QTcF, and QRS interval. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. To ensure safety of the participants, a qualified individual at the investigator site made comparisons to baseline measurements. Pre-defined criteria was defined as 30 milliseconds (ms) less than (<) change less than or equal to (<=) 60 ms. | Safety analysis set included all participants enrolled and took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days) |
|
|
|
| Secondary | Number of Participants With Vital Signs Findings Per Pre-defined Criteria | Vital signs included: supine diastolic blood pressure (DBP) measured in millimetre of mercury (mmHg) with criteria value as follows- Value <50 mmHg, change>= 20 mmHg increase, change >= 20 mmHg decrease; supine pulse rate (PR) measured in beats per minute (bpm) with criteria values as follows- value < 40 bpm, value > 120 bpm; supine systolic blood pressure (SBP, mmHg) with criteria values as follows- value< 90 mmHg, change >= 30 mmHg increase, change >=30 mmHg decrease. Vital signs (SBP BP, and pulse rate) were measured with participants after having a rest for at least 5 minutes in a supine position. Supine BP was measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest. If timing of these measurements coincided with a blood collection, BP and PR were obtained prior to nominal time of blood collection. Only participants having at least 1 vital sign findings per pre-defined criteria are reported. | Safety analysis set included all participants enrolled and took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Physical Examination | A complete physical examination included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included, at a minimum, assessments of general appearance, the respiratory and CV systems, and participant-reported symptoms. Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. Clinical significance of physical examination abnormalities was judged by physicians. | Safety analysis set included all participants enrolled and took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days) |
|
|
|
| Secondary | Time to Reach Cmax (Tmax) of PF-07817883 | Tmax is the time taken (in hours) to reach the maximum serum drug concentration. Tmax was observed directly from data as time of first occurrence. | PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported. | Posted | Median | Full Range | Hours | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
|
|
|
| Secondary | Terminal Phase Half-Life (t1/2) of PF-07817883 | Terminal half-life was defined as the time measured for the plasma concentration of drug to decrease by one half. t1/2 was determined by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported. | Posted | Mean | Standard Deviation | Hours | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
|
|
|
| Secondary | Apparent Clearance (CL/F) of PF-07817883 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose administered divided by area under the concentration curve from time 0 extrapolated to infinite time (AUCinf). | PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/Hours | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/F) of PF-07817883 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Itraconazole | Participants received itraconazole 200 mg orally once in a day (QD) alone from first dose of itraconazole administered alone in Period 2 Day 1 up to just before coadministration of PF-07817883 in Period 2 Day 4. | 0 | 12 | 0 | 12 | 3 | 12 |
| EG002 | Itraconazole + PF-07817883 | Participants received itraconazole 200 mg QD with PF-07817883 300 mg SD from coadministration of PF-07817883 with itraconazole in Period 2 Day 4 through the end of the study. | 0 | 12 | 0 | 12 | 2 | 12 |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA v26.0 | 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.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010879 |
| Piperazines |