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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The investigational product PF 06252616, a humanized anti myostatin monoclonal antibody that neutralizes myostatin (GDF8) is in development for the treatment of Limb Girdle Muscular Dystrophy 2I (LGMD2I) to preserve and/or improve muscle function.
This study will provide the clinical assessment of the safety, tolerability, Pharmacokinetics and Pharmacodynamics of PF 06252616 following repeat IV doses in ambulatory adults with LGMD2I.
This study is a Phase 1b/2, open-label multiple ascending dose escalation study to evaluate the safety, tolerability, efficacy, PK and PD of PF 06252616 in ambulatory adults with LGMD2I. The study design is intended to determine the optimal safe and pharmacologically active dose of PF 06252616 in LGMD2I while providing an opportunity for all subjects to receive active drug for a rare and disabling disorder. The study will be conducted in three periods: Lead-In, Treatment and Follow-up periods. The Lead-In and Follow-up periods will each be 16 weeks to allow an assessment of the change of various outcome measures of this period of time and comparison of change in function before, during and after treatment. The Treatment period will be 32 weeks. Three cohorts of participants will be enrolled and receive escalating doses of PF 06252616. The first cohort will have the option to crossover to the highest dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose, Cohort 1 | Active Comparator | 4 subjects will be enrolled in cohort 1 and will receive an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, if no stopping rules have been met, subjects will be receive an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks. |
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| Middle dose, Cohort 2 | Active Comparator | 8 subjects will be enrolled in cohort 2 and receive 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks. |
|
| High dose, Cohort 3 | Active Comparator | 8 subjects will be enrolled in cohort 3 and receive 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF 06252616 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting or Intolerability Treatment Related Adverse Events | Adverse events include subject-reported symptoms as well as clinically-significant changes in laboratory testing, vital signs, and suicide screening (based on the Columbia Suicide Severity Rating Scale). | Baseline through 64 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration at Steady State (Cmax, ss) of GDF-8 | The concentration of myostatin (GDF-8) was measured in serum 2 hours after dose administration at two visits (Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3)where drug concentration had reached steady state. The highest concentration from these two time points was averaged for each cohort. | Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn R Wagner, MD/PhD | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32429923 | Derived | Leung DG, Bocchieri AE, Ahlawat S, Jacobs MA, Parekh VS, Braverman V, Summerton K, Mansour J, Bibat G, Morris C, Marraffino S, Wagner KR. Longitudinal functional and imaging outcome measures in FKRP limb-girdle muscular dystrophy. BMC Neurol. 2020 May 19;20(1):196. doi: 10.1186/s12883-020-01774-5. |
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One participant in Cohort 2 was consented, but elected to withdraw from the study prior to assignment to a treatment arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose, Cohort 1 | 4 subjects will be enrolled in cohort 1 and will receive an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, if no stopping rules have been met, subjects will be receive an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks. PF 06252616 |
| FG001 | Middle Dose, Cohort 2 | 8 subjects will be enrolled in cohort 2 and receive 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks. PF 06252616 |
| FG002 | High Dose, Cohort 3 | 8 subjects will be enrolled in cohort 3 and receive 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks. PF 06252616 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lead-in (Untreated) |
| |||||||||||||
| Treatment Period |
| |||||||||||||
| Extension Study |
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Target enrollment was reached for Cohort 1 and Cohort 3. For Cohort 2, 8 subjects were screened, but 1 voluntarily withdrew prior to enrollment and was not replaced.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - Low Dose | 4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks. |
| BG001 | Cohort 2 - Middle Dose |
| 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 | Incidence of Dose Limiting or Intolerability Treatment Related Adverse Events | Adverse events include subject-reported symptoms as well as clinically-significant changes in laboratory testing, vital signs, and suicide screening (based on the Columbia Suicide Severity Rating Scale). | All enrolled subjects are included in the analysis. | Posted | Number | events | Baseline through 64 weeks |
|
Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
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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 | Lead-in | All subjects were observed in a 16-week untreated lead-in-phase prior to allocation to dosing cohorts. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain associated with muscle biopsy | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathryn R. Wagner | Hugo W. Moser Research Institute at Kennedy Krieger Inc. | 443-923-9525 | wagnerk@kennedykrieger.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2018 | Jan 22, 2020 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 14, 2018 | Jan 22, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2019 | Jan 22, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| C564612 | Muscular Dystrophy, Limb-Girdle, Type 2I |
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| Minimum Observed Serum Trough Concentration at Steady State (Ctrough,ss) of GDF-8 | The concentration of myostatin (GDF-8) was measured in serum prior to dose administration at two time points (Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3) where drug concentration had reached steady state. The lowest concentration from these two time points was averaged for each cohort. | Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3 |
| Maximum Observed Serum Concentration (Cmax) of PF-06252616 | The peak concentration of study drug (PF-06252616) was measured in serum following dose administration at two time points (Day 113 and Day 169) where drug concentration had reached steady state. The higher concentration from these two time points was averaged for each cohort. | Day 113 and Day 169 |
| Minimum Observed Serum Trough Concentration (Ctrough) of PF-06252616 | The peak concentration of study drug (PF-06252616) was measured in serum prior to dose administration at two time points (Day 113 and Day 169) where drug concentration had reached steady state. The lower concentration from these two time points was averaged for each cohort. | Day 113 and Day 169 |
| Immunogenicity: Incidence of Anti-drug Antibody | Blood samples were tested for the presence of anti-drug antibodies prior to the initiation of study drug, at dose escalation (Cohort 1 only), and at 3 separate time points after the last dose was given. | Baseline through 96 weeks |
| Mean Change From Baseline in 10 Meter Walk/Run Time in Seconds | Subjects are asked to run or walk as quickly as possible for 10 meters from a standing position. The total time to traverse 10 meters is recorded in seconds. | Baseline through 32 weeks |
| Mean Change From Baseline of Forced Vital Capacity in Liters | The total forced vital capacity was measured using a bedside spirometer. The best of 3 trials was recorded. | Baseline through 32 weeks |
| Mean Change From Baseline in 2MWD in Meters | Average change in distance (in meters) walked in 2 minutes. | Baseline through 32 weeks |
| Mean Change From Baseline in TUG in Seconds | The timed-up-and-go test (TUG) is the total time it takes the subject to rise from a seated position, walk to a marker 3 meters away, return to the chair, and sit. | Baseline through 32 weeks |
| Mean Change From Baseline in Muscle Strength as Measured by Modified MRC Scale | Twenty-two muscle groups were measured on a modified MRC scale ranging from 1 through 12. The total scores from all 22 muscle groups were added to generate a summary score ranging from 12 to 264 with higher scores signifying greater strength. The change in summary score was calculated over the first 32 weeks of treatment. | Baseline through 32 weeks |
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7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks. |
| BG002 | Cohort 3 - High Dose | 8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| OG002 | Cohort 3, High Dose | 8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks. |
|
|
| Secondary | Maximum Observed Serum Concentration at Steady State (Cmax, ss) of GDF-8 | The concentration of myostatin (GDF-8) was measured in serum 2 hours after dose administration at two visits (Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3)where drug concentration had reached steady state. The highest concentration from these two time points was averaged for each cohort. | All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 40mg/kg dosing period. | Posted | Mean | Standard Deviation | ng/ml | Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3 |
|
|
|
| Secondary | Minimum Observed Serum Trough Concentration at Steady State (Ctrough,ss) of GDF-8 | The concentration of myostatin (GDF-8) was measured in serum prior to dose administration at two time points (Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3) where drug concentration had reached steady state. The lowest concentration from these two time points was averaged for each cohort. | All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 40mg/kg dosing period. | Posted | Mean | Standard Deviation | ng/ml | Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3 |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) of PF-06252616 | The peak concentration of study drug (PF-06252616) was measured in serum following dose administration at two time points (Day 113 and Day 169) where drug concentration had reached steady state. The higher concentration from these two time points was averaged for each cohort. | All enrolled participants were analyzed. For Cohort 1, measurements are provided for 5mg/kg dosing period. | Posted | Mean | Standard Deviation | ng/ml | Day 113 and Day 169 |
|
|
|
| Secondary | Minimum Observed Serum Trough Concentration (Ctrough) of PF-06252616 | The peak concentration of study drug (PF-06252616) was measured in serum prior to dose administration at two time points (Day 113 and Day 169) where drug concentration had reached steady state. The lower concentration from these two time points was averaged for each cohort. | All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 5mg/kg dosing period. | Posted | Mean | Standard Deviation | ng/ml | Day 113 and Day 169 |
|
|
|
| Secondary | Immunogenicity: Incidence of Anti-drug Antibody | Blood samples were tested for the presence of anti-drug antibodies prior to the initiation of study drug, at dose escalation (Cohort 1 only), and at 3 separate time points after the last dose was given. | All enrolled subjects were included in the analysis. | Posted | Count of Participants | Participants | Baseline through 96 weeks |
|
|
|
| Secondary | Mean Change From Baseline in 10 Meter Walk/Run Time in Seconds | Subjects are asked to run or walk as quickly as possible for 10 meters from a standing position. The total time to traverse 10 meters is recorded in seconds. | All enrolled subject were included in the analysis. For Cohort 1, data is provided for the 5mg/kg dosing period. | Posted | Mean | Standard Deviation | seconds | Baseline through 32 weeks |
|
|
|
| Secondary | Mean Change From Baseline of Forced Vital Capacity in Liters | The total forced vital capacity was measured using a bedside spirometer. The best of 3 trials was recorded. | All enrolled subjects were included in the analysis. For Cohort 1, data is provided for the 5mg/kg dosing period. | Posted | Mean | Standard Deviation | liters | Baseline through 32 weeks |
|
|
|
| Secondary | Mean Change From Baseline in 2MWD in Meters | Average change in distance (in meters) walked in 2 minutes. | All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 5mg/kg dosing period. | Posted | Mean | Standard Deviation | meters | Baseline through 32 weeks |
|
|
|
| Secondary | Mean Change From Baseline in TUG in Seconds | The timed-up-and-go test (TUG) is the total time it takes the subject to rise from a seated position, walk to a marker 3 meters away, return to the chair, and sit. | All enrolled subjects are included in the analysis. For Cohort 1, data is provided for the 5mg/kg dosing period. | Posted | Mean | Standard Deviation | seconds | Baseline through 32 weeks |
|
|
|
| Secondary | Mean Change From Baseline in Muscle Strength as Measured by Modified MRC Scale | Twenty-two muscle groups were measured on a modified MRC scale ranging from 1 through 12. The total scores from all 22 muscle groups were added to generate a summary score ranging from 12 to 264 with higher scores signifying greater strength. The change in summary score was calculated over the first 32 weeks of treatment. | All enrolled participants were analyzed after 32 weeks of treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline through 32 weeks |
|
|
|
| 0 |
| 19 |
| 1 |
| 19 |
| 9 |
| 19 |
| EG001 | Cohort 1 - Low Dose | Subjects received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks for 32 weeks. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG002 | Cohort 1 - High Dose | Following the Low Dose period, subjects in Cohort 1 received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG003 | Cohort 1 Extension | Subjects enrolled in Cohort 1 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 28 weeks. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG004 | Cohort 2 | Subjects received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG005 | Cohort 2 Extension | Subjects enrolled in Cohort 2 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 40 weeks. | 0 | 6 | 1 | 6 | 4 | 6 |
| EG006 | Cohort 3 | Subjects received 40 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG007 | Cohort 3 Extension | Subjects enrolled in Cohort 3 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 24 weeks. | 0 | 6 | 0 | 6 | 6 | 6 |
| Stress fracture | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Numbness following biopsy | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Lower extremity edema following biopsy | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Skin avulsion following biopsy | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Intravenous catheter infiltration | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Ecchymosis at IV site | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Fall - not otherwise specified | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Musculoskeletal pain post fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Fracture - pelvic | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Knee injury post fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Shoulder injury post fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Facial injury post fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Ankle injury post fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Shoulder pain - not otherwise specified | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Knee pain - not otherwise specified | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Neck pain - not otherwise specified | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Hip pain - not otherwise specified | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Worsening cardiomyopathy | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Upper respiratory symptoms | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Flu-like illness | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Environmental allergies | Immune system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Infectious illness - not otherwise specified | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Gastroesophageal reflux | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Decreased appetite | General disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Urinary tract pain | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Prostatic hypertrophy | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Hematuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Vaginal yeast infection | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Vision abnormality - not otherwise specified | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Eye twitching | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Ear infection | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Hearing loss | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Rash - not otherwise specified | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Cold sore | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Cyst - not otherwise specified | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Dental injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Dental infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Weight gain | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment | Greater than 5% of baseline weight |
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| Weight loss | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment | Greater than 5% of baseline weight |
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| Fatigue | General disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Syncope | General disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Hypoglycemia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Ketones detected in urine | Investigations | MedDRA 20.1 | Non-systematic Assessment |
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| Red blood cells in urine | Investigations | MedDRA 20.1 | Non-systematic Assessment |
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| Elevated serum iron levels | Investigations | MedDRA 20.1 | Non-systematic Assessment |
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| Low serum iron levels | Investigations | MedDRA 20.1 | Non-systematic Assessment |
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| Elevated amylase | Investigations | MedDRA 20.1 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Elevated serum ferritin | Investigations | MedDRA 20.1 | Non-systematic Assessment |
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| Low serum ferritin | Investigations | MedDRA 20.1 | Non-systematic Assessment |
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| Hemoccult positive | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| New diagnosis - carpal tunnel syndrome | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| New diagnosis - hepatic steatosis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
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| New diagnosis - umbilical hernia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| New diagnosis - bipolar disorder | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
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| New diagnosis - personality disorder | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
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