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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001255-31 | EudraCT Number |
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This study is designed to evaluate the safety, tolerability and efficacy of long-term treatment with PF-06741086 in subjects with severe hemophilia who participated in the 3-month Phase 1b/2 B7841002 study. Additionally, de novo subjects will be recruited into this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06741086 (Cohort 1) | Experimental |
| |
| PF-06741086 (Cohort 2) | Experimental |
| |
| PF-06741086 (Cohort 3) | Experimental |
| |
| PF-06741086 (Cohort 4) | Experimental |
| |
| PF-06741086 (Cohort 5) | Experimental |
| |
| PF-06741086 (Cohort 6) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06741086 | Biological | PF-06741086 subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), TEAEs by Severity, and Serious Adverse Events (SAEs) (All Causality and Treatment-Related) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. Grades 3 AEs were severe and undesirable adverse events. Grades 4 AEs were life threatening or disabling adverse events. | Day 1 up to Day 393 |
| Number of Participants With Abnormal Laboratory Findings Without Regard to Baseline Abnormality (Including Hematology, Serum Chemistry, and Urinalysis) | Following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The hematology parameters and pre-defined criteria included: neutrophils (10^3/millimeter[mm]^3) <0.8*lower limit of normal (LLN), and basophils (10^3/mm^3) >1.2*upper limit of normal (ULN). The clinical chemistry parameter and pre-defined criteria included: bilirubin (milligrams [mg]/decilitre [dL]) >1.5 ULN, aspartate aminotransferase (units [U]/liter [L]) >3.0 ULN, glucose (mg/dL) >1.5*ULN. The urinalysis parameter and pre-defined criteria included: urine glucose ≥1, ketones (scalar) ≥1, urine protein ≥1, urine hemoglobin (scalar) ≥1, and hyaline casts per low power field (/LPF). Participants met criteria at any time point were included. | Hematology and serum chemistry: Baseline, Days 1, 29, 57, 85, 169, 253, and 365 visits. Urinalysis: Baseline, Days 1, 85, 169, 253, and 365 visits. |
| Number of Participants With Changes From Baseline in Vital Signs Measurements Meeting the Pre-Defined Categorical Summarization Criteria | Following parameters were analyzed for vital sign examination: blood pressure (BP), pulse rate (PR), temperature, respiration rate. Categorical vital signs: Temperature >38.5 degree(s) Celsius (℃), Supine PR: <40 or >120 beats per minute (BPM), Systolic BP: <90 mm Hg, >=30 mm Hg change from baseline, Diastolic BP: <50 mm Hg, >=20 mm Hg change from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Bleeding Rate (ABR) | The ABR was calculated as ([number of bleeding events × 365.25] / observed treatment period in days) | Day 1 to Day 365, and Day 393 visit. Pre-Treatment summarized the data up to 6 months prior to participation in B7841003 for de novo participants and up to 6 months prior to participation in B7841002 for roll over participants. |
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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 |
|---|---|---|---|---|---|---|
| UC Denver Hemophilia and Thrombosis Center | Aurora | Colorado | 80045 | United States | ||
| Centro de Hematologia e Hemoterapia de Campinas- Hemocentro de Campinas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36220152 | Derived | Mahlangu J, Luis Lamas J, Cristobal Morales J, Malan DR, Teeter J, Charnigo RJ, Hwang E, Arkin S. Long-term safety and efficacy of the anti-tissue factor pathway inhibitor marstacimab in participants with severe haemophilia: Phase II study results. Br J Haematol. 2023 Jan;200(2):240-248. doi: 10.1111/bjh.18495. Epub 2022 Oct 11. |
| 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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Twenty-four participants were screened, of which, 4 failed at screening. All the 20 participants who met the eligibility criteria were assigned to the study treatment and were treated with marstacimab. Among 20 participants treated with marstacimab, 18 completed the study, and 2 discontinued from study due to withdrawal by participant, which were not related to safety.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: 300mg - 300mg Non-Inhibitor | Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) from Cohort 1 of Study 1002 (B7841002, NCT02974855) continued to receive PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 365. |
| FG001 | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Participants without inhibitors to FVIII or FIX from Cohort 2 of Study 1002 continued to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365. |
| FG002 | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Participants without inhibitors to FVIII or FIX from Cohort 3 (450 mg SC) of Study 1002 started to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365. |
| FG003 | Cohort 4: 300mg - 300mg Inhibitor | Participants with inhibitors to FVIII or FIX from Cohort 4 (300 mg SC) of Study 1002 continued to receive PF-06741086 300 mg SC QW from Day 1 to Day 365. |
| FG004 | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors | De Novo participants with inhibitors to FVIII or FIX received a 300 mg SC loading dose on Day 1, and then followed by 150 mg SC QW to Day 365. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population included all participants who received at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: 300mg - 300mg Non-Inhibitor | Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) from Cohort 1 of Study 1002 (B7841002, NCT02974855) continued to receive PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 365. |
| BG001 | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 With Treatment-Emergent Adverse Events (TEAEs), TEAEs by Severity, and Serious Adverse Events (SAEs) (All Causality and Treatment-Related) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. Grades 3 AEs were severe and undesirable adverse events. Grades 4 AEs were life threatening or disabling adverse events. | The analysis population included all participants who received at least 1 dose of investigational product. Here "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Day 1 up to Day 393 |
Day 1 up to Day 393
The same event may appear as both an AE and an 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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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 | Cohort 1: 300mg - 300mg Non-Inhibitor | Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) from Cohort 1 of Study 1002 (B7841002, NCT02974855) continued to receive PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 365. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral haemorrhage | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Food poisoning | Gastrointestinal disorders | MedDRA v23.0 | 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 | Nov 8, 2018 | May 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2018 | May 17, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000656192 | marstacimab |
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| Baseline, Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 and 393 visits. |
| Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters Meeting the Pre-defined Categorical Summarization Criteria | Baseline was defined as the average of triplicate ECG measurements collected prior to dosing on Day 1 in B7841003. Criteria for potentially clinically important changes in ECG were defined as: PR interval value >=300 millisecond (msec); PR interval baseline >200 msec and change >=25%; PR interval baseline <=200 msec and change >=50%; QRS complex value >=140 msec and change >=50%; QTcF value >=450 msec and change >=30 msec. Only the number of participants meeting pre-defined criteria was reported below. | Baseline, Days 1 and 29 visits |
| Number of Participants With Abnormalities in Physical Examination Findings | Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. For measuring weight, a scale with appropriate range and resolution was used and must have been placed on a stable, flat surface. Participants removed shoes, bulky layers of clothing, and jackets so that only light clothing remains. They also removed the contents of their pockets and remain still during measurement of weight. | Day 1 to Day 393 |
| Number of Participants With Injection Site Reactions | Injection site reactions included but were not limited to: erythema, induration, ecchymosis, pain and pruritus. Grade of severity was defined as follows: Mild: Transient or mild discomfort (< 48 hours); no medical intervention/therapy required. Moderate: Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. | Day 1 to Day 365, and Day 393 visit. |
| Campinas |
| São Paulo |
| 13083-878 |
| Brazil |
| Hospital Dr. Sotero del Rio | Santiago | Puente ALTO | 8207257 | Chile |
| Klinicki bolnicki centar Zagreb | Zagreb | 10000 | Croatia |
| Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Phoenix Pharma (Pty) Ltd | Port Elizabeth | Eastern Cape | 6001 | South Africa |
| Charlotte Maxeke Johannesburg Academic Hospital | Johannesburg | Gauteng | 2193 | South Africa |
| UniversitatsSpital Zurich | Zurich | 8091 | Switzerland |
Participants without inhibitors to FVIII or FIX from Cohort 2 of Study 1002 continued to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365. |
| BG002 | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Participants without inhibitors to FVIII or FIX from Cohort 3 (450 mg SC) of Study 1002 started to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365. |
| BG003 | Cohort 4: 300mg - 300mg Inhibitor | Participants with inhibitors to FVIII or FIX from Cohort 4 (300 mg SC) of Study 1002 continued to receive PF-06741086 300 mg SC QW from Day 1 to Day 365. |
| BG004 | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors | De Novo participants with inhibitors to FVIII or FIX received a 300 mg SC loading dose on Day 1, and then followed by 150 mg SC QW to Day 365. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Cohort 1: 300mg - 300mg Non-Inhibitor | Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) from Cohort 1 of Study 1002 (B7841002, NCT02974855) continued to receive PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 365. |
| OG001 | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Participants without inhibitors to FVIII or FIX from Cohort 2 of Study 1002 continued to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365. |
| OG002 | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Participants without inhibitors to FVIII or FIX from Cohort 3 (450 mg SC) of Study 1002 started to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365. |
| OG003 | Cohort 4: 300mg - 300mg Inhibitor | Participants with inhibitors to FVIII or FIX from Cohort 4 (300 mg SC) of Study 1002 continued to receive PF-06741086 300 mg SC QW from Day 1 to Day 365. |
| OG004 | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors | De Novo participants with inhibitors to FVIII or FIX received a 300 mg SC loading dose on Day 1, and then followed by 150 mg SC QW to Day 365. |
|
|
| Primary | Number of Participants With Abnormal Laboratory Findings Without Regard to Baseline Abnormality (Including Hematology, Serum Chemistry, and Urinalysis) | Following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The hematology parameters and pre-defined criteria included: neutrophils (10^3/millimeter[mm]^3) <0.8*lower limit of normal (LLN), and basophils (10^3/mm^3) >1.2*upper limit of normal (ULN). The clinical chemistry parameter and pre-defined criteria included: bilirubin (milligrams [mg]/decilitre [dL]) >1.5 ULN, aspartate aminotransferase (units [U]/liter [L]) >3.0 ULN, glucose (mg/dL) >1.5*ULN. The urinalysis parameter and pre-defined criteria included: urine glucose ≥1, ketones (scalar) ≥1, urine protein ≥1, urine hemoglobin (scalar) ≥1, and hyaline casts per low power field (/LPF). Participants met criteria at any time point were included. | This analysis population included all participants who received at least 1 dose of investigational product. Here "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Hematology and serum chemistry: Baseline, Days 1, 29, 57, 85, 169, 253, and 365 visits. Urinalysis: Baseline, Days 1, 85, 169, 253, and 365 visits. |
|
|
|
| Primary | Number of Participants With Changes From Baseline in Vital Signs Measurements Meeting the Pre-Defined Categorical Summarization Criteria | Following parameters were analyzed for vital sign examination: blood pressure (BP), pulse rate (PR), temperature, respiration rate. Categorical vital signs: Temperature >38.5 degree(s) Celsius (℃), Supine PR: <40 or >120 beats per minute (BPM), Systolic BP: <90 mm Hg, >=30 mm Hg change from baseline, Diastolic BP: <50 mm Hg, >=20 mm Hg change from baseline. | This analysis population included all participants who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline, Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 and 393 visits. |
|
|
|
| Primary | Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters Meeting the Pre-defined Categorical Summarization Criteria | Baseline was defined as the average of triplicate ECG measurements collected prior to dosing on Day 1 in B7841003. Criteria for potentially clinically important changes in ECG were defined as: PR interval value >=300 millisecond (msec); PR interval baseline >200 msec and change >=25%; PR interval baseline <=200 msec and change >=50%; QRS complex value >=140 msec and change >=50%; QTcF value >=450 msec and change >=30 msec. Only the number of participants meeting pre-defined criteria was reported below. | ECG was only evaluated in de novo participants. | Posted | Count of Participants | Participants | Baseline, Days 1 and 29 visits |
|
|
|
| Primary | Number of Participants With Abnormalities in Physical Examination Findings | Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. For measuring weight, a scale with appropriate range and resolution was used and must have been placed on a stable, flat surface. Participants removed shoes, bulky layers of clothing, and jackets so that only light clothing remains. They also removed the contents of their pockets and remain still during measurement of weight. | The analysis population included all participants who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Day 1 to Day 393 |
|
|
|
| Primary | Number of Participants With Injection Site Reactions | Injection site reactions included but were not limited to: erythema, induration, ecchymosis, pain and pruritus. Grade of severity was defined as follows: Mild: Transient or mild discomfort (< 48 hours); no medical intervention/therapy required. Moderate: Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. | This analysis population included all participants who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Day 1 to Day 365, and Day 393 visit. |
|
|
|
| Secondary | Annualized Bleeding Rate (ABR) | The ABR was calculated as ([number of bleeding events × 365.25] / observed treatment period in days) | This efficacy analysis was conducted in the Per Protocol Analysis Set (PPAS) that included all participants who received at least 1 dose of investigational product and did not have any major protocol deviations. | Posted | Mean | Standard Deviation | Bleeding episodes/participant/year | Day 1 to Day 365, and Day 393 visit. Pre-Treatment summarized the data up to 6 months prior to participation in B7841003 for de novo participants and up to 6 months prior to participation in B7841002 for roll over participants. |
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| 5 |
| 5 |
| EG001 | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Participants without inhibitors to FVIII or FIX from Cohort 2 of Study 1002 continued to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG002 | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Participants without inhibitors to FVIII or FIX from Cohort 3 (450 mg SC) of Study 1002 started to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG003 | Cohort 4: 300mg - 300mg Inhibitor | Participants with inhibitors to FVIII or FIX from Cohort 4 (300 mg SC) of Study 1002 continued to receive PF-06741086 300 mg SC QW from Day 1 to Day 365. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG004 | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors | De Novo participants with inhibitors to FVIII or FIX received a 300 mg SC loading dose on Day 1, and then followed by 150 mg SC QW to Day 365. | 0 | 2 | 0 | 2 | 1 | 2 |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Joint warmth | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v23.0 | 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.
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
|
| Hematology Basophils (10^3/mm^3) >1.2*ULN |
|
|
| Clinical Chemistry Bilirubin (mg/dL) >1.5*ULN |
|
|
| Clinical Chemistry Aspartate Aminotransferase (U/L) >3.0*ULN |
|
|
| Clinical Chemistry Glucose (mg/dL) >1.5*ULN |
|
|
| Urinalysis URINE Glucose ≥1 |
|
|
| Urinalysis Ketones (Scalar) ≥1 |
|
|
| Urinalysis URINE Protein ≥1 |
|
|
| Urinalysis URINE Hemoglobin (Scalar) ≥1 |
|
|
| Urinalysis Hyaline Casts (/LPF) >1 |
|
|
| Systolic BP Change ≥30 mm Hg increase |
|
| Systolic BP Change ≥30 mm Hg decrease |
|
| Diastolic BP (mmHg) < 50 |
|
| Diastolic BP Change ≥20 mm Hg increase |
|
| Diastolic BP Change ≥20 mm Hg decrease |
|
| Supine PR (BPM) <40 |
|
| Supine PR (BPM) >120 |
|
| Temperature >38.5 ℃ |
|
| Title | Measurements |
|---|---|
|
| QRS complex value >=140 msec |
|
| QRS complex change >=50% |
|
| 450 <= QTcF Value (msec) < 480 |
|
| 480 <= QTcF Value (msec) < 450 |
|
| QTcF Value >= 500 msec |
|
| 30 <= QTcF Change (msec) < 60 |
|
| QTcF Change >= 60 msec |
|
| Erythema (redness) Moderate |
|
| Erythema (redness) Severe |
|
| Induration (swelling) Mild |
|
| Induration (swelling) Moderate |
|
| Induration (swelling) Severe |
|
| Ecchymosis (bruising) Mild |
|
| Ecchymosis (bruising) Moderate |
|
| Ecchymosis (bruising) Severe |
|
| Pain (after injection) Mild |
|
| Pain (after injection) Moderate |
|
| Pain (after injection) Severe |
|
| Pruritus (itching) Mild |
|
| Pruritus (itching) Moderate |
|
| Pruritus (itching) Severe |
|
| Other Mild |
|
| Other Moderate |
|
| Other Severe |
|
| Any injection site reaction Mild |
|
| Any injection site reaction Moderate |
|
| Any injection site reaction Severe |
|
| On-Study |
|