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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003144-76 | EudraCT Number | ||
| C5341023 | Other Identifier | Alias Study Number |
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Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.
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Open-label extension study of voxelotor for participants with Sickle Cell Disease who have participated in voxelotor clinical trials.
Open-label extension (OLE) study of voxelotor for participants with Sickle Cell Disease who have participated in voxelotor clinical trials. Up to approximately 600 participants with sickle cell disease (SCD), will be enrolled at approximately 70 clinical sites globally. All participants will receive voxelotor once daily, administered orally as tablets, dispersible tablets, or powder for oral suspension formulation. The objective of this OLE is to assess the safety of, and SCD-related complications of, long-term treatment with voxelotor, in participants who have completed treatment in a Global Blood Therapeutics (GBT)-sponsored voxelotor clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voxelotor | Experimental | All participants will receive voxelotor once daily (QD), administered orally as tablets, dispersible tablets, or a stick pack formulation (powder blend formulation packaged as stick packs). Participants aged ≥ 12 years and/or ≥ 40 kgs will receive a voxelotor dose of 1500 mg QD. Participants aged < 12 years and < 40 kgs will receive weight based dosing of voxelotor. The participant's weight at study entry will be used to determine the starting voxelotor dose in this study. Participants may receive study drug as long they continue to receive clinical benefit that outweighs risk as determined by the investigator and/or until the participant has access to voxelotor from an alternative source. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voxelotor | Drug | All participants will receive voxelotor once daily (QD), administered orally as tablets, dispersible tablets, or a powder for oral suspension formulation (powder formulation packaged as stick packs). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered to be drug related. A treatment emergent AE was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. AEs included both serious AEs (SAEs) and all non-SAEs. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) |
| Number of Participants With SAEs | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered to be drug related. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) |
| Number of Participants With Sickle Cell Disease (SCD) Related TEAEs and SAEs | SCD-related AEs were common complications associated with the study participant's SCD and were not considered to be related to voxelotor unless judged by the investigator to have worsened in severity and/or frequency or changed in nature during the study. SCD-related complications included the following: sickle cell anemia with crisis, acute chest syndrome (ACS), pneumonia, priapism, and osteonecrosis. A treatment emergent AE was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. |
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Inclusion Criteria:
Note: Participants who discontinued study drug due to an AE, but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with voxelotor.
Note: Participants who discontinued Study GBT440-032 as the result of an abnormal transcranial Doppler (TCD) flow velocity assessment (≥ 200 cm/sec) are eligible for treatment in this study.
- Participant has provided written consent/assent (for pediatric participants, both the consent of the participant's legal representative or legal guardian and the participant's assent [where applicable] must be obtained).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Children's Healthcare of Atlanta Scottish Rite |
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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 162 participants who had previously completed the following studies: GBT440-032 (NCT04218084) who received placebo, and GBT440-007 (NCT02850406), GBT440-032 (NCT04218084) or GBT440-042 (NCT05561140) who received voxelotor were enrolled in the study GBT440-038 (NCT04188509). All participants enrolled in this study received voxelotor.
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| ID | Title | Description |
|---|---|---|
| FG000 | Voxelotor | Participants aged >= 12 years received voxelotor 1500 milligrams (mg) once daily (QD) tablets. Participants aged < 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Voxelotor | Participants aged >= 12 years received voxelotor 1500 mg QD tablets. Participants aged < 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source. |
| 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 Treatment Emergent Adverse Events (AEs) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered to be drug related. A treatment emergent AE was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. AEs included both serious AEs (SAEs) and all non-SAEs. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. | The safety population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) |
|
From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years)
Same events may appear as both SAE and non-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. The safety population included all participants who received at least one dose of study drug.
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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 | Voxelotor | Participants aged >= 12 years received voxelotor 1500 milligrams (mg) once daily (QD) tablets. Participants aged < 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA28.0 | 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 | Jun 16, 2023 | Oct 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2024 | Oct 29, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C000628792 | voxelotor |
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Open-Label Extension study available to eligible participants from GBT-sponsored voxelotor clinical studies.
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|
| From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| ECU Physicians, Brody Outpatient Clinic | Greenville | North Carolina | 27834 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Zagazig University Hospital | Zagazig | Alsharkia | Egypt |
| Alexandria University Hospital - Clinical Research Center | Alexandria | 21131 | Egypt |
| Cairo University Hospital, Abu El Rish Hospital | Cairo | 11562 | Egypt |
| Ain Shams University Hospital - Clinical Research Center (MASRI-CRC) | Cairo | Egypt |
| American University of Beirut - Medical Center | Beirut | Lebanon |
| Nini Hospital | Tripoli | Lebanon |
| University of Calabar Teaching Hospital | Calabar | Cross River State | 540281 | Nigeria |
| College of Medicine, University of Ibadan | Ibadan | Oyo State | 200212 | Nigeria |
| Barau Dikko Teaching Hospital/Kaduna State University | Kaduna | 800212 | Nigeria |
| Aminu Kano Teaching Hospital | Kano | 700233 | Nigeria |
| Lagos University Teaching Hospital | Lagos | 100254 | Nigeria |
| University College Hospital NHS Foundation Trust | London | Greater London | NW1 2PG | United Kingdom |
| Barts Health NHS Trust , The Royal London Hospital | London | E1 1BB | United Kingdom |
| Guy'S and St Thomas' Nhs Foundation Trust | London | SE1 7EH | United Kingdom |
| Discretion of Investigator |
|
| Noncompliance |
|
| Sponsor Decision |
|
| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 |
| Voxelotor |
Participants aged >= 12 years received voxelotor 1500 milligrams (mg) once daily (QD) tablets. Participants aged < 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source. |
|
|
| Primary | Number of Participants With SAEs | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered to be drug related. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. | The safety population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) |
|
|
|
| Primary | Number of Participants With Sickle Cell Disease (SCD) Related TEAEs and SAEs | SCD-related AEs were common complications associated with the study participant's SCD and were not considered to be related to voxelotor unless judged by the investigator to have worsened in severity and/or frequency or changed in nature during the study. SCD-related complications included the following: sickle cell anemia with crisis, acute chest syndrome (ACS), pneumonia, priapism, and osteonecrosis. A treatment emergent AE was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. | The safety population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) |
|
|
|
| 1 |
| 162 |
| 53 |
| 162 |
| 93 |
| 162 |
| Anaemia | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Splenic sequestration crisis | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Haemolysis | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Urethral valves | Congenital, familial and genetic disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Coronavirus infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Wound sepsis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Acute haemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA28.0 | Non-systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Priapism | Reproductive system and breast disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Acute chest syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Paranasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Splenic sequestration crisis | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Cytopenia | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Hypersplenism | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Macrocytosis | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Cholesteatoma | Ear and labyrinth disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Vernal keratoconjunctivitis | Eye disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Anal pruritus | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Decreased activity | General disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Swelling face | General disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Coronavirus infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Enterovirus infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Mumps | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Periorbital cellulitis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA28.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA28.0 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA28.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA28.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA28.0 | Non-systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA28.0 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA28.0 | Non-systematic Assessment |
|
| Traumatic pain | Injury, poisoning and procedural complications | MedDRA28.0 | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Red cell distribution width abnormal | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Blood urea decreased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Mean cell volume decreased | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA28.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Cluster headache | Nervous system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Painful erection | Reproductive system and breast disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Priapism | Reproductive system and breast disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Acute chest syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Splenectomy | Surgical and medical procedures | MedDRA28.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA28.0 | Non-systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA28.0 | 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.
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |