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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004545-24 | EudraCT Number |
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The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dasiglucagon first then placebo | Experimental | 48 hours of dasiglucagon subcutaneous (sc) infusion starting at 10 µg/hour with crossover to 48 hours placebo sc infusion (part 1) followed by 21 days of dasiglucagon sc infusion (part 2). |
|
| placebo first then dasiglucagon | Experimental | 48 hours of placebo sc infusion with crossover to 48 hours dasiglucagon sc infusion starting at 10 µg/hour (part 1) followed by 21 days of dasiglucagon sc infusion (part 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dasiglucagon | Drug | Glucagon analogue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intravenous Glucose Infusion Rate | Mean intravenous (IV) glucose infusion rate (GIR) in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration). | Hours 36-48 after initiation of trial drug (Part 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Carbohydrates Administered | Total amount (g) of carbohydrates administered during the crossover part of the trial (dasiglucagon or placebo administration) per day. | 0 to 48 hours after initiation of trial drug |
| Mean Intravenous Glucose Infusion Rate |
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Inclusion Criteria:
CHI diagnosis established based on the following:
Male or female, age ≥7 days and <12 months at screening
Body weight of ≥2.0 kg (4.4 lbs.)
Continuous IV glucose requirement to prevent hypoglycemia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jelena Ivkovic, MD | Zealand Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States | ||
| Cook Children's Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasiglucagon, Then Placebo | Patients were treated with dasiglucagon for 48 hours in Part 1-1, then placebo for 48 hours in Part 1-2, and then dasiglucagon for 21 days in Part 2 |
| FG001 | Placebo, Then Dasiglucagon | Patients were treated with placebo for 48 hours in Part 1-1, then dasiglucagon for 48 hours in Part 1-2, and then dasiglucagon for 21 days in Part 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1-1: First Intervention (48 Hours) |
| |||||||||||||
| Part 1-2: Second Intervention (48 Hours) |
| |||||||||||||
| Part 2: Open Label Dasiglucagon |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Who Received Treatment | All participants who received treatment |
| 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 | Mean Intravenous Glucose Infusion Rate | Mean intravenous (IV) glucose infusion rate (GIR) in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration). | Posted | Mean | Standard Deviation | mg/kg/minute | Hours 36-48 after initiation of trial drug (Part 1) |
|
Treatment-emergent adverse events are reported here, and were recorded from the time of first administration of study treatment until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 8 weeks, from Day 1 through Day 56).
Note that the reporting groups are not mutually exclusive.
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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 | Part 1: Dasiglucagon | Adverse events during administration of dasiglucagon during Part 1 of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Teglman Schiøler | Zealand Pharma A/S | +45 5060 3722 | cschioler@zealandpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2021 | Jul 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2022 | Jul 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D044903 | Congenital Hyperinsulinism |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C000710373 | dasiglucagon |
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| Placebo | Drug | Placebo for dasiglucagon |
|
Mean IV GIR for each 48-hour treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration).
| 48 hours after initiation of trial drug (Part 1) |
| Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Mean IV GIR below 10 mg/kg/minute in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration) (yes/no) | Hours 36-48 after initiation of trial drug (Part 1) |
| Time to Complete Weaning Off Intravenous Glucose | Time in days to complete weaning off IV glucose administration during Part 2, defined as the first point in time when the patient had been off IV glucose administration for at least 12 hours. | Days 5 to 25 (Part 2) |
| Hypoglycemia Event Rate in Part 2 | Hypoglycemia event rate, defined as number of hypoglycemic events when PG was <70 mg/dL (or 3.9 mmol/L), as detected by self-monitored plasma glucose. | Days 5 to 25 |
| Clinically Significant Hypoglycemia Events in Part 2 | Clinically significant hypoglycemia event rate, defined as number of events when PG was <54 mg/dL (3.0 mmol/L), as detected by self-monitored plasma glucose. | Days 5 to 25 |
| Time to Actual Hospital Discharge | Time in days to actual hospital discharge defined as the time from first exposure to the study drug in Part 2 to discharge from hospital. | Days 5 to 25 |
| Time to Pancreatic Surgery | Time (days) to pancreatic surgery (sub-total or total pancreatectomy with a cutoff of ≥95%). | Days 5 to 25 |
| Carbohydrates Administered | Total amount (g) of carbohydrates administered (regardless of the route) per day. | Days 5 to 25 |
| Carbohydrates Administered Intravenously | Amount (g) of carbohydrates administered via IV glucose infusion or bolus or total parenteral nutrition. This secondary endpoint was intended to account only for carbohydrates administered via IV glucose infusion or bolus. It was not possible to differentiate between carbohydrates administered via IV glucose infusion or bolus and carbohydrates administered as being, or not being, part of total parenteral nutrition from the collected data. This endpoint was expanded to include both. | Days 5 to 25 |
| Carbohydrates Administered Parenterally | Amount (g) of carbohydrates administered as part of total parenteral nutrition. | Days 5 to 25 |
| Carbohydrates Administered Orally | Amount (g) of carbohydrates administered via oral route. | Days 5 to 25 |
| Carbohydrates Administered Via Gastric Feed | Amount (g) of carbohydrates administered via nasogastric tube or gastrostomy. | Days 5 to 25 |
| Time in Range in Part 2 | Percent time in range (PG between 70 to 180 mg/dL [3.9-10.0 mmol/L]) as measured by continuous glucose monitoring. | Days 5 to 25 |
| Time in Hypoglycemia in Part 2 | Percent time in hypoglycemia (when PG was <70 mg/dL [or 3.9 mmol/L]) as measured by continuous glucose monitoring. | Days 5 to 25 |
| Time in Clinically Significant Hypoglycemia in Part 2 | Percent time in clinically significant hypoglycemia (when PG was <54 mg/dL [or 3.0 mmol/L]) as measured by continuous glucose monitoring. | Days 5 to 25 |
| Hypoglycemia Episodes in Part 2 | Rate of hypoglycemia episodes, defined as number of episodes per week when PG was <70 mg/dL (3.9 mmol/L) for 15 minutes or more, as measured by continuous glucose monitoring. | Days 5 to 25 |
| Clinically Significant Hypoglycemia Episodes in Part 2 | Rate of clinically significant hypoglycemia episodes, defined as number of episodes per week when was <54 mg/dL (3.0 mmol/L) for 15 minutes or more, as measured by continuous glucose monitoring. | Days 5 to 25 |
| Extent of Hypoglycemia in Part 2 | Extent of hypoglycemia (defined as the area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by continuous glucose monitoring. | Days 5 to 25 |
| Extent of Clinically Significant Hypoglycemia in Part 2 | Extent of clinically significant hypoglycemia (defined as the area over the glucose curve [AOCglucose] below 54 mg/dL [3.0 mmol/L]) as measured by continuous glucose monitoring, divided by the total duration in hours of continuous glucose monitoring. | Days 5 to 25 |
| Time in Hyperglycemia in Part 2 | Percent time in hyperglycemia (when PG was >180 mg/dL [10.0 mmol/L]), as measured by continuous glucose monitoring. | Days 5 to 25 |
| Fort Worth |
| Texas |
| 76104 |
| United States |
| University Children's Hospital | Düsseldorf | 40225 | Germany |
| University Hospital, Magdeburg | Magdeburg | 39120 | Germany |
| Hadassah Medical Center | Jerusalem | 9765422 | Israel |
| Manchester University NHS Foundation Trust | Manchester | M13 9WL | United Kingdom |
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Gastrostomy/nasogastric tube | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Carbohydrates Administered | Total amount (g) of carbohydrates administered during the crossover part of the trial (dasiglucagon or placebo administration) per day. | Posted | Mean | Standard Deviation | g/day | 0 to 48 hours after initiation of trial drug |
|
|
|
|
| Secondary | Mean Intravenous Glucose Infusion Rate | Mean IV GIR for each 48-hour treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration). | Posted | Mean | Standard Deviation | mg/kg/minute | 48 hours after initiation of trial drug (Part 1) |
|
|
|
| Secondary | Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Mean IV GIR below 10 mg/kg/minute in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration) (yes/no) | Posted | Count of Participants | Participants | Hours 36-48 after initiation of trial drug (Part 1) |
|
|
|
| Secondary | Time to Complete Weaning Off Intravenous Glucose | Time in days to complete weaning off IV glucose administration during Part 2, defined as the first point in time when the patient had been off IV glucose administration for at least 12 hours. | Posted | Median | 95% Confidence Interval | days | Days 5 to 25 (Part 2) |
|
|
|
| Secondary | Hypoglycemia Event Rate in Part 2 | Hypoglycemia event rate, defined as number of hypoglycemic events when PG was <70 mg/dL (or 3.9 mmol/L), as detected by self-monitored plasma glucose. | Self-monitored plasma glucose episodes were set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study. | Posted | Median | Full Range | episodes per week | Days 5 to 25 |
|
|
|
| Secondary | Clinically Significant Hypoglycemia Events in Part 2 | Clinically significant hypoglycemia event rate, defined as number of events when PG was <54 mg/dL (3.0 mmol/L), as detected by self-monitored plasma glucose. | Self-monitored plasma glucose episodes were set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study. | Posted | Median | Full Range | episodes per week | Days 5 to 25 |
|
|
|
| Secondary | Time to Actual Hospital Discharge | Time in days to actual hospital discharge defined as the time from first exposure to the study drug in Part 2 to discharge from hospital. | Posted | Median | 95% Confidence Interval | days | Days 5 to 25 |
|
|
|
| Secondary | Time to Pancreatic Surgery | Time (days) to pancreatic surgery (sub-total or total pancreatectomy with a cutoff of ≥95%). | Posted | Median | 95% Confidence Interval | days | Days 5 to 25 |
|
|
|
| Secondary | Carbohydrates Administered | Total amount (g) of carbohydrates administered (regardless of the route) per day. | Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study. | Posted | Median | Full Range | g/day | Days 5 to 25 |
|
|
|
| Secondary | Carbohydrates Administered Intravenously | Amount (g) of carbohydrates administered via IV glucose infusion or bolus or total parenteral nutrition. This secondary endpoint was intended to account only for carbohydrates administered via IV glucose infusion or bolus. It was not possible to differentiate between carbohydrates administered via IV glucose infusion or bolus and carbohydrates administered as being, or not being, part of total parenteral nutrition from the collected data. This endpoint was expanded to include both. | Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study. | Posted | Median | Full Range | g/day | Days 5 to 25 |
|
|
|
| Secondary | Carbohydrates Administered Parenterally | Amount (g) of carbohydrates administered as part of total parenteral nutrition. | It was not possible to differentiate between carbohydrates administered via IV glucose infusion or bolus and carbohydrates administered as being, or not being, part of total parenteral nutrition because some of the carbohydrates that were given as a part of parenteral nutrition were also reported as carbohydrates administered intravenously. All available results regarding administration of carbohydrates are presented in outcome measure 11. | Posted | Days 5 to 25 |
|
|
| Secondary | Carbohydrates Administered Orally | Amount (g) of carbohydrates administered via oral route. | Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study. | Posted | Median | Full Range | g/day | Days 5 to 25 |
|
|
|
| Secondary | Carbohydrates Administered Via Gastric Feed | Amount (g) of carbohydrates administered via nasogastric tube or gastrostomy. | Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study. | Posted | Median | Full Range | g/day | Days 5 to 25 |
|
|
|
| Secondary | Time in Range in Part 2 | Percent time in range (PG between 70 to 180 mg/dL [3.9-10.0 mmol/L]) as measured by continuous glucose monitoring. | Data were not available from all patients during all weeks. | Posted | Median | Full Range | percent time | Days 5 to 25 |
|
|
|
| Secondary | Time in Hypoglycemia in Part 2 | Percent time in hypoglycemia (when PG was <70 mg/dL [or 3.9 mmol/L]) as measured by continuous glucose monitoring. | Data were not available from all patients during all weeks. | Posted | Median | Full Range | percent time | Days 5 to 25 |
|
|
|
| Secondary | Time in Clinically Significant Hypoglycemia in Part 2 | Percent time in clinically significant hypoglycemia (when PG was <54 mg/dL [or 3.0 mmol/L]) as measured by continuous glucose monitoring. | Data were not available from all patients during all weeks. | Posted | Median | Full Range | percent time | Days 5 to 25 |
|
|
|
| Secondary | Hypoglycemia Episodes in Part 2 | Rate of hypoglycemia episodes, defined as number of episodes per week when PG was <70 mg/dL (3.9 mmol/L) for 15 minutes or more, as measured by continuous glucose monitoring. | Data were not available from all patients during all weeks. | Posted | Median | Full Range | episodes per week | Days 5 to 25 |
|
|
|
| Secondary | Clinically Significant Hypoglycemia Episodes in Part 2 | Rate of clinically significant hypoglycemia episodes, defined as number of episodes per week when was <54 mg/dL (3.0 mmol/L) for 15 minutes or more, as measured by continuous glucose monitoring. | Data were not available from all patients during all weeks. | Posted | Median | Full Range | episodes per week | Days 5 to 25 |
|
|
|
| Secondary | Extent of Hypoglycemia in Part 2 | Extent of hypoglycemia (defined as the area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by continuous glucose monitoring. | Data were not available from all patients during all weeks. | Posted | Median | Full Range | mg/dL/hour | Days 5 to 25 |
|
|
|
| Secondary | Extent of Clinically Significant Hypoglycemia in Part 2 | Extent of clinically significant hypoglycemia (defined as the area over the glucose curve [AOCglucose] below 54 mg/dL [3.0 mmol/L]) as measured by continuous glucose monitoring, divided by the total duration in hours of continuous glucose monitoring. | Data were not available from all patients during all weeks. | Posted | Median | Full Range | mg/dL/hour | Days 5 to 25 |
|
|
|
| Secondary | Time in Hyperglycemia in Part 2 | Percent time in hyperglycemia (when PG was >180 mg/dL [10.0 mmol/L]), as measured by continuous glucose monitoring. | Data were not available from all patients from all weeks. | Posted | Median | Full Range | percent time | Days 5 to 25 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Part 1: Placebo | Adverse events during administration of placebo during Part 1 of the study. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG002 | Part 2: Dasiglucagon | Adverse events during administration of dasiglucagon during Part 2 of the study. | 0 | 12 | 1 | 12 | 10 | 12 |
| EG003 | Parts 1 and 2: Dasiglucagon | Adverse events during administration of dasiglucagon during Parts 1 and 2 of the study. | 0 | 12 | 1 | 12 | 10 | 12 |
| EG004 | Follow-up Period | Adverse events occurring during the Follow-up Period. | 0 | 1 | 0 | 1 | 1 | 1 |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Finger Deformity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Acne Infantile | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Seborrhoeic Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Sensitive Skin | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Acidosis Hyperchloraemic | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Fluid Retention | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Face Oedema | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Medical Device Site Reaction | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Thrombophlebitis Superficial | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
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| Normocytic Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
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| Device Related Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Eye Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Fungal Skin Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Oral Candidiasis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Parainfluenzae Virus Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Rash Pustular | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA 21.1 | Systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Haemangioma Of Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Device Occlusion | Product Issues | MedDRA 21.1 | Systematic Assessment |
|
Not provided
Not provided
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007003 | Hypoglycemia |
|
| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Title | Measurements |
|---|---|
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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| Title | Measurements |
|---|---|
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| Week 3 (Days 19 to 25) |
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| Weeks 1 to 3 (Days 5 to 25) |
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