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| ID | Type | Description | Link |
|---|---|---|---|
| C5341026 | 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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This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS).
The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voxeletor + SOC (Standard of Care) | Experimental |
| |
| Placebo + SOC (Standard of Care) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voxelotor Oral Tablet | Drug | Synthetic small molecule supplied as 500 mg tablets, administered Orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Resolution of the Target Ulcers by Week 12 in Randomized Treatment Period | An ulcer qualified as a target ulcer, if met the following criteria: a) duration of ulcer was greater than equal to (>=) 2 weeks and less than (<) 6 months at screening; b) healed by <25 percent (%) during the SOC run-in phase prior to randomization; c) size was greater than (>2) square centimeters (cm^2) at any visit, prior to randomization. Resolution of the target ulcer was defined as skin re-epithelialization confirmed at 2 consecutive study visits, 2 weeks apart during the 12-week randomized treatment period. For participants with more than one target ulcer, all target ulcers must be confirmed resolved in order for the participant to be a responder. | Through Week 12 of randomized treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resolution of Target Ulcers up to Week 12 in Randomized Treatment Period | An ulcer qualified as a target ulcer, if met the following criteria: a) duration of ulcer was >=2 weeks and <6 months at screening; b) healed by <25% during the SOC run-in phase prior to randomization; c) size was >2 cm^2 at any visit, prior to randomization. Resolution of the target ulcer was defined as skin re-epithelialization confirmed at 2 consecutive study visits, 2 weeks apart during the 12-week randomized treatment period. Time to resolution of target ulcers was defined as the first time of the observed ulcer was resolved. For participants with more than one target ulcer, time to resolution of target ulcers was defined as time to the last target ulcer confirmed resolved. For participants who did not have the last target ulcer confirmed resolved by Week 12 or who were discontinued from study, the time to resolution was censored. Median time to event was evaluated using Kaplan-Meier method. |
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Inclusion Criteria:
Male or female participants with documented diagnosis of SCD (HbSS, HbS/β0 thalassemia)
Age 12 years and older
At least 1 cutaneous ulcer(s) on the lower extremity (leg, ankle, or dorsum of foot) that meets the following criteria:
Written informed consent (≥ 18 years) or parental/guardian consent and participant assent (≥ 12-17 years) per IEC policy and requirements, consistent with ICH guidelines
Exclusion Criteria:
Other protocol-defined Eligibility Criteria that apply
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complexo Hospitalar Universitário Professor Edgard Santos- Universidade Federal Da Bahia | Salvador | Estado de Bahia | 40110-060 | Brazil | ||
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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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Eligible participants were randomized to receive study drug for 12 weeks in DB randomized period.Following this,eligible participants received voxelotor (delayed) for minimum 12 weeks in OL period. Participants were followed up for 4 weeks after last dose of study drug. All participants received the SOC per investigator/protocol for SCD leg ulcers.
A total of 88 participants with sickle cell disease (SCD) were enrolled, randomized and treated with study drug for leg ulcers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Voxelotor (Blinded) + SOC Then Voxelotor (Open Label) + SOC | Participants were randomized to receive voxelotor 1500 milligram (mg) (3 tablets*500 mg) orally once daily (OD) and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, continued to receive voxelotor 1500 mg (3 tablets*500 mg) orally OD and SOC for minimum of 12 weeks. |
| FG001 | Placebo (Blinded) + SOC Then Voxelotor (Open Label) + SOC | Participants were randomized to receive placebo matched to voxelotor, orally OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, received voxelotor 1500 mg (3 tablets*500 mg) orally OD and SOC for minimum of 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized Treatment Period |
|
| |||||||||||||||||||||
| Open Label Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Voxelotor (Blinded) + SOC Then Voxelotor (Open Label) + SOC | Participants were randomized to receive voxelotor 1500 mg (3 tablets*500 mg) orally, OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, continued to receive voxelotor 1500 mg (3 tablets*500 mg) orally OD and SOC for minimum of 12 weeks. |
| 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 | Percentage of Participants Who Achieved Resolution of the Target Ulcers by Week 12 in Randomized Treatment Period | An ulcer qualified as a target ulcer, if met the following criteria: a) duration of ulcer was greater than equal to (>=) 2 weeks and less than (<) 6 months at screening; b) healed by <25 percent (%) during the SOC run-in phase prior to randomization; c) size was greater than (>2) square centimeters (cm^2) at any visit, prior to randomization. Resolution of the target ulcer was defined as skin re-epithelialization confirmed at 2 consecutive study visits, 2 weeks apart during the 12-week randomized treatment period. For participants with more than one target ulcer, all target ulcers must be confirmed resolved in order for the participant to be a responder. | Intention to treat (ITT) population included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Through Week 12 of randomized treatment period |
|
Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo, Blinded | Participants who received placebo matched to voxelotor, orally, once daily for 12 weeks in blinded treatment period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA v27.1 | 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 | Dec 25, 2023 | Jun 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 17, 2024 | Jun 23, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D007871 | Leg Ulcer |
| 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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| Placebo | Other | Placebo |
|
| From Day 1 to censoring date before Week 12 or maximum up to Week 12 of randomized treatment period, whichever occurred first |
| Change From Baseline in Total Surface Area of Target Ulcers at Week 12 in Randomized Treatment Period | An ulcer qualified as a target ulcer, if met the following criteria: a) duration of ulcer was >=2 weeks and <6 months at screening; b) healed by <25% during the SOC run-in phase prior to randomization; c) size was >2 cm^2 at any visit, prior to randomization. | Baseline, Week 12 of randomized treatment period |
| Percentage of Participants With New Ulcers by Week 12 in Randomized Treatment Period | New ulcers were defined as ulcer(s) that were not captured at visit 1/screening. In this outcome measure, participants with occurrence of new ulcers during 12 weeks of treatment were considered. | Through Week 12 of randomized treatment period |
| Universidade Federal Da Bahia Hospital Universitário Professor Edgard Santos |
| Salvador |
| Estado de Bahia |
| 40110-060 |
| Brazil |
| Hospital São Rafael | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Hospital das Clinicas da Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Multihemo Servicos Medicos S/A | Recife | Pernambuco | 50070-460 | Brazil |
| Hospital das ClÃnicas da Faculdade de Medicina da Universidade de Sao Paulo | Cerqueira Cesar - Sao Paulo | São Paulo | 05403-000 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de Sao Paulo | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| Esho Empresa De Servicos Hospitalares S.A/ Hospital Samaritano Higienopolis | São Paulo | 01232-010 | Brazil |
| Hospital das ClÃnicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | 01246-000 | Brazil |
| Hospital das ClÃnicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | 05403-000 | Brazil |
| KEMRI Centre for Clinical Research Butere County Hospital | Butere | Kakamega County | 50100 | Kenya |
| KEMRI Kondele Children's Hospital within Jaramogi Oginga Odinga Teaching and Referral Hospital. | Kisumu | 40100 | Kenya |
| Gertrude's Children's Hospital | Nairobi | 00100 | Kenya |
| KEMRI-Centre for Respiratory Diseases Research-Nairobi | Nairobi | 00100 | Kenya |
| Strathmore University Medical Centre | Nairobi | 00200 | Kenya |
| KEMRI-CRDR, KEMRI Clinical Research Annex | Siaya | 40600 | Kenya |
| SYNLAB | Gwagwalada | Abuja | 902101 | Nigeria |
| University of Calabar Teaching Hospital | Calabar | Cross River State | 540281 | Nigeria |
| SYNLAB | Abuja | Federal Capital Territory | 902101 | Nigeria |
| University of Abuja Teaching Hospital | Gwagwalada | Federal Capital Territory | 902101 | 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 |
| NOT COMPLETED |
|
|
| BG001 | Placebo (Blinded) + SOC Then Voxelotor (Open Label) + SOC | Participants were randomized to receive placebo matched to voxelotor, orally OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, received voxelotor 1500 mg (3 tablets*500 mg) orally OD and SOC for minimum of 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants were randomized to receive voxelotor 1500 mg (3 tablets*500 mg) orally, OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, continued to receive voxelotor 1500 mg (3 tablets*500 mg) orally OD and SOC for minimum of 12 weeks. |
| OG001 | Placebo (Blinded) + SOC Then Voxelotor (Open Label) + SOC | Participants were randomized to receive placebo matched to voxelotor, orally OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, received voxelotor 1500 mg (3 tablets*500 mg) orally OD and SOC for minimum of 12 weeks. |
|
|
|
| Secondary | Time to Resolution of Target Ulcers up to Week 12 in Randomized Treatment Period | An ulcer qualified as a target ulcer, if met the following criteria: a) duration of ulcer was >=2 weeks and <6 months at screening; b) healed by <25% during the SOC run-in phase prior to randomization; c) size was >2 cm^2 at any visit, prior to randomization. Resolution of the target ulcer was defined as skin re-epithelialization confirmed at 2 consecutive study visits, 2 weeks apart during the 12-week randomized treatment period. Time to resolution of target ulcers was defined as the first time of the observed ulcer was resolved. For participants with more than one target ulcer, time to resolution of target ulcers was defined as time to the last target ulcer confirmed resolved. For participants who did not have the last target ulcer confirmed resolved by Week 12 or who were discontinued from study, the time to resolution was censored. Median time to event was evaluated using Kaplan-Meier method. | ITT population included all randomized participants. | Posted | Median | 95% Confidence Interval | Days | From Day 1 to censoring date before Week 12 or maximum up to Week 12 of randomized treatment period, whichever occurred first |
|
|
|
| Secondary | Change From Baseline in Total Surface Area of Target Ulcers at Week 12 in Randomized Treatment Period | An ulcer qualified as a target ulcer, if met the following criteria: a) duration of ulcer was >=2 weeks and <6 months at screening; b) healed by <25% during the SOC run-in phase prior to randomization; c) size was >2 cm^2 at any visit, prior to randomization. | ITT population included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | cm^2 | Baseline, Week 12 of randomized treatment period |
|
|
|
|
| Secondary | Percentage of Participants With New Ulcers by Week 12 in Randomized Treatment Period | New ulcers were defined as ulcer(s) that were not captured at visit 1/screening. In this outcome measure, participants with occurrence of new ulcers during 12 weeks of treatment were considered. | ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Through Week 12 of randomized treatment period |
|
|
|
|
| 0 |
| 43 |
| 14 |
| 43 |
| 25 |
| 43 |
| EG001 | Voxelotor, Blinded | Participants who received voxelotor 1500 mg (3 tablets*500 mg) orally, once daily for 12 weeks in blinded treatment period. | 1 | 45 | 18 | 45 | 37 | 45 |
| EG002 | Delayed Voxelotor, Open Label | Participants who received placebo matched to voxelotor, orally, once daily for 12 weeks in blinded treatment period and then who received at least one dose of voxelotor 1500 mg (3 tablets*500 mg) orally, once daily in open label treatment period. | 4 | 43 | 25 | 43 | 36 | 43 |
| EG003 | Voxelotor, Open Label | Participants who received voxelotor 1500 mg (3 tablets*500 mg) orally, once daily for 12 weeks in blinded treatment period and then who received at least one dose of voxelotor 1500 mg (3 tablets*500 mg) orally, once daily in open label treatment period. | 6 | 43 | 30 | 43 | 31 | 43 |
| Pneumonia | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Acute chest syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Hepatic sequestration | Hepatobiliary disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Priapism | Reproductive system and breast disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Haemolysis | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Complicated malaria | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
|
| Hepatitis C antibody positive | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Dengue haemorrhagic fever | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Venous ulcer pain | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication 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 |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |