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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004473-27 | EudraCT Number | ||
| 2023-504004-29-00 | EU Trial (CTIS) Number |
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The primary objective of this study is to determine the long-term safety of DTX401 following a single intravenous (IV) dose in adults with GSDIa.
Only participants who received DTX401 in study 401GSDIA01 (NCT03517085) are eligible to participate in study 401GSDIA02. No investigational product will be administered during study 401GSDIA02. Participants will be followed in study 401GSDIA02 for at least 4 years, and up to 6 years after administration of DTX401.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTX401 Cohort 1 | Participants received a single intravenous (IV) dose of 2.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. |
| |
| DTX401 Cohort 2 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. |
| |
| DTX401 Cohort 3 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. |
| |
| DTX401 Cohort 4 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Discontinuations Due to TEAEs | An adverse event (AE) is defined as any untoward medical occurrence, regardless of its causal relationship to study product. A TEAE is defined as any AE not present prior to the initiation of the drug treatment or any AE already present that worsens in either intensity or frequency following exposure to the drug treatment. A serious TEAE is an AE that meets any of the following criteria in the view of either the Investigator or Ultragenyx: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; disability/Incapacity; congenital anomaly/birth defect not present at screening; other important medical events. Severity of events were graded as mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4), or death (grade 5). As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs. | From Baseline (Week 52 of 401GSDIA01/Visit 1 of 401GSDIA02) Up to Week 329 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time | The change from baseline in time (in hours) to first hypoglycemic event (defined as glucose < 54 mg/dL [< 3.0 mmol/L]) during a controlled fasting challenge at the participant's last visit. A positive change from baseline is favorable. Change from baseline is calculated from Baseline (Week 0) of the 401GSDIA01 study. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 18 years of age or older with GSDIa previously enrolled in 401GSDIA01.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Ultragenyx Pharmaceutical Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCONN Health | Farmington | Connecticut | 06030-3213 | United States | ||
| Michigan Medicine University of Michigan |
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| Label | URL |
|---|---|
| Ultragenyx Transparency Commitment | View source |
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Due to the rarity of GSDIa and the small number of subjects in this trial, individual patient data will not be shared in order to safeguard patient privacy, consistent with the data sharing commitment statement listed on Ultragenyx.com.
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All 12 participants were dosed with DTX401 in study 401GSDIA01 (NCT03517085); after completing 52 weeks of follow-up in study 401GSDIA01, they subsequently enrolled in study 401GSDIA02 for an overall mean study duration of 276.2 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTX401 Cohort 1 | Participants received a single intravenous (IV) dose of 2.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| FG001 | DTX401 Cohort 2 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| FG002 | DTX401 Cohort 3 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| FG003 | DTX401 Cohort 4 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DTX401 Cohort 1 | Participants received a single intravenous (IV) dose of 2.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| BG001 |
| 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), Serious TEAEs and Discontinuations Due to TEAEs | An adverse event (AE) is defined as any untoward medical occurrence, regardless of its causal relationship to study product. A TEAE is defined as any AE not present prior to the initiation of the drug treatment or any AE already present that worsens in either intensity or frequency following exposure to the drug treatment. A serious TEAE is an AE that meets any of the following criteria in the view of either the Investigator or Ultragenyx: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; disability/Incapacity; congenital anomaly/birth defect not present at screening; other important medical events. Severity of events were graded as mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4), or death (grade 5). As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs. | Full Analysis Set: participants enrolled in Study 401GSDIA02 who received a dose of DTX401 in Study 401GSDIA01. | Posted | Count of Participants | Participants | From Baseline (Week 52 of 401GSDIA01/Visit 1 of 401GSDIA02) Up to Week 329 |
All AEs were collected from signing of informed consent (Visit 1, ie, Week 52 of 401GSDIA01) through the Last Visit (up to Week 329). SAEs were collected for up to 30 days after the Last Visit.
Any AEs that were ongoing at the completion of 401GSDIA01 were considered medical history in 401GSDIA02. As DTX401 was administered as part of Study 401GSDIA01, all AEs in Study 401GSDIA02 were considered TEAEs.
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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 | DTX401 Cohort 1 | Participants received a single intravenous (IV) dose of 2.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Ultragenyx Pharmaceutical Inc | 1-888-756-8657 | medinfo@ultragenyx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 3, 2023 | Jan 22, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2024 | Jan 22, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C538655 | Hepatorenal form of glycogen storage disease |
| D005953 | Glycogen Storage Disease Type I |
| D044882 | Glucose Metabolism Disorders |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| ID | Term |
|---|---|
| D006008 | Glycogen Storage Disease |
| D008661 | Metabolism, Inborn Errors |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
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Blood
| Baseline (Week 0 of 401GSDIA01), Weeks 52 (Visit 1 of 401GSDIA02), 78, 104, 130, 156, 182, 208, 234, 260, Last Visit (Up to Week 329) |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Montreal Children Hospital, McGill University Health Centre | Montreal | Quebec | H4A3J1 | Canada |
| University Medical Center Groningen | Groningen | 9700RB | Netherlands |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | A Coruna | 15706 | Spain |
| DTX401 Cohort 2 |
Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| BG002 | DTX401 Cohort 3 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| BG003 | DTX401 Cohort 4 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| BG004 | 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 |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | DTX401 Cohort 1 | Participants received a single intravenous (IV) dose of 2.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| OG001 | DTX401 Cohort 2 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| OG002 | DTX401 Cohort 3 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
| OG003 | DTX401 Cohort 4 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study. No intervention: No intervention |
|
|
| Secondary | Change From Baseline in Time to First Hypoglycemic Event During a Controlled Fasting Challenge Over Time | The change from baseline in time (in hours) to first hypoglycemic event (defined as glucose < 54 mg/dL [< 3.0 mmol/L]) during a controlled fasting challenge at the participant's last visit. A positive change from baseline is favorable. Change from baseline is calculated from Baseline (Week 0) of the 401GSDIA01 study. | Full Analysis Set: participants enrolled in Study 401GSDIA02 who received a dose of DTX401 in Study 401GSDIA01. Participants with an assessment at given timepoint. | Posted | Mean | Standard Deviation | hours | Baseline (Week 0 of 401GSDIA01), Weeks 52 (Visit 1 of 401GSDIA02), 78, 104, 130, 156, 182, 208, 234, 260, Last Visit (Up to Week 329) |
|
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | DTX401 Cohort 2 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | DTX401 Cohort 3 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with an optimized reactive steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study | 0 | 3 | 2 | 3 | 3 | 3 |
| EG003 | DTX401 Cohort 4 | Participants received a single IV dose of 6.0 × 10^12 GC/kg DTX401(pariglasgene brecaparvovec) with a prophylactic steroid regimen during their participation in study 401GSDIA01 (NCT03517085). No intervention was provided during the 401GSDIA02 long term follow up study | 0 | 3 | 2 | 3 | 3 | 3 |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Escherichia Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Gastroenteritis Norovirus | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Blood Lactic Acid Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lactic Acidosis | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Optic Neuritis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Eating Disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
|
| Preoperative Care | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
|
| Hypertensive Urgency | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nephrogenic Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cardiac Flutter | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Glycogen Storage Disorder | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Food Poisoning | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pelvic Floor Dysfunction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Catheter Site Discharge | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Infusion Site Extravasation | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatic Mass | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Food Allergy | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Corneal Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea Infectious | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Epididymitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Gastritis Viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Gastrointestinal Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Gastrointestinal Viral Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Corneal Abrasion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Nail Injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Post Procedural Fistula | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Stoma Site Irritation | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Vaccination Complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Activated Partial Thromboplastin Time Prolonged | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Albumin Urine Present | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood Glucose Fluctuation | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood Lactic Acid Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Glomerular Filtration Rate Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Haematocrit Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Neutrophil Count Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Platelet Count Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Prothrombin Time Prolonged | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Sars-Cov-2 Test Positive | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Transaminases Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Haemangioma Of Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Sensory Disturbance | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Drug Abuse | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Mood Swings | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Microalbuminuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory Symptom | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Skin Fissures | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
| D009750 | Nutritional and Metabolic Diseases |
|
| Change at Week 78 |
|
|
| Change at Week 104 |
|
|
| Change at Week 130 |
|
|
| Change at Week 156 |
|
|
| Change at Week 182 |
|
|
| Change at Week 208 |
|
|
| Change at Week 234 |
|
|
| Change at Week 260 |
|
|
| Change at Last Visit |
|
|