Trial Outcomes & Findings for Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism (NCT NCT04172441)
NCT ID: NCT04172441
Last Updated: 2025-03-14
Results Overview
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).
COMPLETED
PHASE2/PHASE3
12 participants
Hours 36-48 after initiation of trial drug (Part 1)
2025-03-14
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Part 1-1: First Intervention (48 Hours)
STARTED
|
7
|
5
|
|
Part 1-1: First Intervention (48 Hours)
COMPLETED
|
7
|
5
|
|
Part 1-1: First Intervention (48 Hours)
NOT COMPLETED
|
0
|
0
|
|
Part 1-2: Second Intervention (48 Hours)
STARTED
|
7
|
5
|
|
Part 1-2: Second Intervention (48 Hours)
COMPLETED
|
7
|
5
|
|
Part 1-2: Second Intervention (48 Hours)
NOT COMPLETED
|
0
|
0
|
|
Part 2: Open Label Dasiglucagon
STARTED
|
7
|
5
|
|
Part 2: Open Label Dasiglucagon
Completed Treatment
|
7
|
4
|
|
Part 2: Open Label Dasiglucagon
COMPLETED
|
7
|
5
|
|
Part 2: Open Label Dasiglucagon
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
Baseline characteristics by cohort
| Measure |
All Participants Who Received Treatment
n=12 Participants
All participants who received treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
71.25 Days
STANDARD_DEVIATION 84.976 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
|
Gastrostomy/nasogastric tube
Gastrostomy
|
2 Participants
n=5 Participants
|
|
Gastrostomy/nasogastric tube
Nasogastric tube
|
7 Participants
n=5 Participants
|
|
Gastrostomy/nasogastric tube
None
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hours 36-48 after initiation of trial drug (Part 1)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).
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
n=12 Participants
All patients treated with placebo in Part 1
|
|---|---|---|
|
Mean Intravenous Glucose Infusion Rate
|
4.33 mg/kg/minute
Standard Deviation 4.922
|
9.51 mg/kg/minute
Standard Deviation 5.655
|
SECONDARY outcome
Timeframe: 0 to 48 hours after initiation of trial drugTotal amount (g) of carbohydrates administered during the crossover part of the trial (dasiglucagon or placebo administration) per day.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
n=12 Participants
All patients treated with placebo in Part 1
|
|---|---|---|
|
Carbohydrates Administered
|
106.7 g/day
Standard Deviation 53.72
|
139.1 g/day
Standard Deviation 57.35
|
SECONDARY outcome
Timeframe: 48 hours after initiation of trial drug (Part 1)Mean IV GIR for each 48-hour treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration).
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
n=12 Participants
All patients treated with placebo in Part 1
|
|---|---|---|
|
Mean Intravenous Glucose Infusion Rate
|
6.9 mg/kg/minute
Standard Deviation 5.91
|
10.4 mg/kg/minute
Standard Deviation 5.31
|
SECONDARY outcome
Timeframe: Hours 36-48 after initiation of trial drug (Part 1)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)
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
n=12 Participants
All patients treated with placebo in Part 1
|
|---|---|---|
|
Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute
Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: yes
|
9 Participants
|
6 Participants
|
|
Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute
Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: no
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Days 5 to 25 (Part 2)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.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Time to Complete Weaning Off Intravenous Glucose
|
5.8 days
Interval 1.0 to 7.9
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: 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.
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.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Hypoglycemia Event Rate in Part 2
Week 1 (Days 5 to 11)
|
8.50 episodes per week
Interval 0.0 to 29.0
|
—
|
|
Hypoglycemia Event Rate in Part 2
Week 2 (Days 12 to 18)
|
6.0 episodes per week
Interval 0.0 to 37.3
|
—
|
|
Hypoglycemia Event Rate in Part 2
Week 3 (Days 19 to 25)
|
3.79 episodes per week
Interval 0.0 to 15.2
|
—
|
|
Hypoglycemia Event Rate in Part 2
Weeks 1 to 3 (Days 5 to 25)
|
6.04 episodes per week
Interval 1.7 to 33.2
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: 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.
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.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Clinically Significant Hypoglycemia Events in Part 2
Week 1 (Days 5 to 11)
|
1.67 episodes per week
Interval 0.0 to 11.0
|
—
|
|
Clinically Significant Hypoglycemia Events in Part 2
Week 2 (Days 12 to 18)
|
1.00 episodes per week
Interval 0.0 to 16.3
|
—
|
|
Clinically Significant Hypoglycemia Events in Part 2
Week 3 (Days 19 to 25)
|
2.92 episodes per week
Interval 0.0 to 4.0
|
—
|
|
Clinically Significant Hypoglycemia Events in Part 2
Weeks 1 to 3 (Days 5 to 25)
|
1.67 episodes per week
Interval 0.3 to 13.7
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Time in days to actual hospital discharge defined as the time from first exposure to the study drug in Part 2 to discharge from hospital.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Time to Actual Hospital Discharge
|
NA days
Interval 11.7 to
A median value and upper limit of the 95% confidence interval were not calculable due to an insufficient number of patients being discharged from hospital.
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Time (days) to pancreatic surgery (sub-total or total pancreatectomy with a cutoff of ≥95%).
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Time to Pancreatic Surgery
|
NA days
The median value and 95% confidence interval were not calculable due to an insufficient number of patients undergoing sub-total or total pancreatectomy with a cutoff of ≥95%.
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study.
Total amount (g) of carbohydrates administered (regardless of the route) per day.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Carbohydrates Administered
Week 1 (Days 5 to 11)
|
91.03 g/day
Interval 57.6 to 190.8
|
—
|
|
Carbohydrates Administered
Week 2 (Days 12 to 18)
|
75.09 g/day
Interval 29.8 to 218.3
|
—
|
|
Carbohydrates Administered
Week 3 (Days 19 to 25)
|
80.73 g/day
Interval 0.0 to 222.1
|
—
|
|
Carbohydrates Administered
Weeks 1 to 3 (Days 5 to 25)
|
87.37 g/day
Interval 39.5 to 195.9
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study.
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.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Carbohydrates Administered Intravenously
Week 1 (Days 5 to 11)
|
41.35 g/day
Interval 3.6 to 118.8
|
—
|
|
Carbohydrates Administered Intravenously
Week 2 (Days 12 to 18)
|
2.12 g/day
Interval 0.0 to 82.2
|
—
|
|
Carbohydrates Administered Intravenously
Week 3 (Days 19 to 25)
|
0.35 g/day
Interval 0.0 to 119.0
|
—
|
|
Carbohydrates Administered Intravenously
Weeks 1 to 3 (Days 5 to 25)
|
22.60 g/day
Interval 1.2 to 88.5
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: 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.
Amount (g) of carbohydrates administered as part of total parenteral nutrition.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 5 to 25Population: Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study.
Amount (g) of carbohydrates administered via oral route.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Carbohydrates Administered Orally
Week 1 (Days 5 to 11)
|
19.57 g/day
Interval 0.0 to 67.5
|
—
|
|
Carbohydrates Administered Orally
Week 2 (Days 12 to 18)
|
0.37 g/day
Interval 0.0 to 88.9
|
—
|
|
Carbohydrates Administered Orally
Week 3 (Days 19 to 25)
|
0.23 g/day
Interval 0.0 to 53.8
|
—
|
|
Carbohydrates Administered Orally
Weeks 1 to 3 (Days 5 to 25)
|
13.38 g/day
Interval 0.0 to 63.4
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study.
Amount (g) of carbohydrates administered via nasogastric tube or gastrostomy.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Carbohydrates Administered Via Gastric Feed
Week 1 (Days 5 to 11)
|
34.43 g/day
Interval 0.0 to 88.7
|
—
|
|
Carbohydrates Administered Via Gastric Feed
Week 2 (Days 12 to 18)
|
52.87 g/day
Interval 9.0 to 92.8
|
—
|
|
Carbohydrates Administered Via Gastric Feed
Week 3 (Days 19 to 25)
|
57.90 g/day
Interval 0.0 to 76.1
|
—
|
|
Carbohydrates Administered Via Gastric Feed
Weeks 1 to 3 (Days 5 to 25)
|
43.96 g/day
Interval 0.0 to 85.0
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Data were not available from all patients during all weeks.
Percent time in range (PG between 70 to 180 mg/dL \[3.9-10.0 mmol/L\]) as measured by continuous glucose monitoring.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Time in Range in Part 2
Week 1 (Days 5 to 11)
|
86.69 percent time
Interval 34.5 to 94.3
|
—
|
|
Time in Range in Part 2
Week 2 (Days 12 to 18)
|
87.87 percent time
Interval 51.0 to 95.9
|
—
|
|
Time in Range in Part 2
Week 3 (Days 19 to 25)
|
91.42 percent time
Interval 36.3 to 100.0
|
—
|
|
Time in Range in Part 2
Weeks 1 to 3 (Days 5 to 25)
|
88.35 percent time
Interval 42.5 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Data were not available from all patients during all weeks.
Percent time in hypoglycemia (when PG was \<70 mg/dL \[or 3.9 mmol/L\]) as measured by continuous glucose monitoring.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Time in Hypoglycemia in Part 2
Week 1 (Days 5 to 11)
|
7.20 percent time
Interval 1.0 to 24.5
|
—
|
|
Time in Hypoglycemia in Part 2
Week 2 (Days 12 to 18)
|
8.82 percent time
Interval 0.6 to 49.0
|
—
|
|
Time in Hypoglycemia in Part 2
Week 3 (Days 19 to 25)
|
5.73 percent time
Interval 0.0 to 22.1
|
—
|
|
Time in Hypoglycemia in Part 2
Weeks 1 to 3 (Days 5 to 25)
|
6.67 percent time
Interval 0.0 to 30.0
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Data were not available from all patients during all weeks.
Percent time in clinically significant hypoglycemia (when PG was \<54 mg/dL \[or 3.0 mmol/L\]) as measured by continuous glucose monitoring.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Time in Clinically Significant Hypoglycemia in Part 2
Week 1 (Days 5 to 11)
|
2.07 percent time
Interval 0.2 to 6.0
|
—
|
|
Time in Clinically Significant Hypoglycemia in Part 2
Week 2 (Days 12 to 18)
|
2.20 percent time
Interval 0.0 to 20.4
|
—
|
|
Time in Clinically Significant Hypoglycemia in Part 2
Week 3 (Days 19 to 25)
|
0.88 percent time
Interval 0.0 to 6.8
|
—
|
|
Time in Clinically Significant Hypoglycemia in Part 2
Weeks 1 to 3 (Days 5 to 25)
|
1.75 percent time
Interval 0.0 to 9.2
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Data were not available from all patients during all weeks.
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.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Hypoglycemia Episodes in Part 2
Week 1 (Days 5 to 11)
|
25.00 episodes per week
Interval 3.0 to 58.0
|
—
|
|
Hypoglycemia Episodes in Part 2
Week 2 (Days 12 to 18)
|
26.50 episodes per week
Interval 3.0 to 74.7
|
—
|
|
Hypoglycemia Episodes in Part 2
Week 3 (Days 19 to 25)
|
18.63 episodes per week
Interval 0.0 to 58.3
|
—
|
|
Hypoglycemia Episodes in Part 2
Weeks 1 to 3 (Days 5 to 25)
|
18.54 episodes per week
Interval 0.0 to 66.3
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Data were not available from all patients during all weeks.
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.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Clinically Significant Hypoglycemia Episodes in Part 2
Week 1 (Days 5 to 11)
|
5.00 episodes per week
Interval 1.0 to 23.0
|
—
|
|
Clinically Significant Hypoglycemia Episodes in Part 2
Week 2 (Days 12 to 18)
|
8.50 episodes per week
Interval 0.0 to 46.7
|
—
|
|
Clinically Significant Hypoglycemia Episodes in Part 2
Week 3 (Days 19 to 25)
|
2.67 episodes per week
Interval 0.0 to 18.7
|
—
|
|
Clinically Significant Hypoglycemia Episodes in Part 2
Weeks 1 to 3 (Days 5 to 25)
|
5.00 episodes per week
Interval 0.0 to 34.8
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Data were not available from all patients during all weeks.
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.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Extent of Hypoglycemia in Part 2
Week 1 (Days 5 to 11)
|
0.87 mg/dL/hour
Interval 0.1 to 2.7
|
—
|
|
Extent of Hypoglycemia in Part 2
Week 2 (Days 12 to 18)
|
0.97 mg/dL/hour
Interval 0.0 to 8.9
|
—
|
|
Extent of Hypoglycemia in Part 2
Week 3 (Days 19 to 25)
|
0.59 mg/dL/hour
Interval 0.1 to 2.6
|
—
|
|
Extent of Hypoglycemia in Part 2
Weeks 1 to 3 (Days 5 to 25)
|
0.89 mg/dL/hour
Interval 0.1 to 4.3
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Data were not available from all patients during all weeks.
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.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Extent of Clinically Significant Hypoglycemia in Part 2
Week 1 (Days 5 to 11)
|
0.14 mg/dL/hour
Interval 0.0 to 0.4
|
—
|
|
Extent of Clinically Significant Hypoglycemia in Part 2
Week 2 (Days 12 to 18)
|
0.13 mg/dL/hour
Interval 0.0 to 2.1
|
—
|
|
Extent of Clinically Significant Hypoglycemia in Part 2
Week 3 (Days 19 to 25)
|
0.12 mg/dL/hour
Interval 0.0 to 0.4
|
—
|
|
Extent of Clinically Significant Hypoglycemia in Part 2
Weeks 1 to 3 (Days 5 to 25)
|
0.14 mg/dL/hour
Interval 0.0 to 0.8
|
—
|
SECONDARY outcome
Timeframe: Days 5 to 25Population: Data were not available from all patients from all weeks.
Percent time in hyperglycemia (when PG was \>180 mg/dL \[10.0 mmol/L\]), as measured by continuous glucose monitoring.
Outcome measures
| Measure |
Dasiglucagon
n=12 Participants
All patients treated with dasiglucagon in Part 1
|
Placebo
All patients treated with placebo in Part 1
|
|---|---|---|
|
Time in Hyperglycemia in Part 2
Week 1 (Days 5 to 11)
|
1.74 percent time
Interval 0.0 to 64.5
|
—
|
|
Time in Hyperglycemia in Part 2
Week 2 (Days 12 to 18)
|
0.81 percent time
Interval 0.0 to 45.0
|
—
|
|
Time in Hyperglycemia in Part 2
Week 3 (Days 19 to 25)
|
0.32 percent time
Interval 0.0 to 62.7
|
—
|
|
Time in Hyperglycemia in Part 2
Weeks 1 to 3 (Days 5 to 25)
|
1.48 percent time
Interval 0.0 to 56.6
|
—
|
Adverse Events
Part 1: Dasiglucagon
Part 1: Placebo
Part 2: Dasiglucagon
Parts 1 and 2: Dasiglucagon
Follow-up Period
Serious adverse events
| Measure |
Part 1: Dasiglucagon
n=12 participants at risk
Adverse events during administration of dasiglucagon during Part 1 of the study.
|
Part 1: Placebo
n=12 participants at risk
Adverse events during administration of placebo during Part 1 of the study.
|
Part 2: Dasiglucagon
n=12 participants at risk
Adverse events during administration of dasiglucagon during Part 2 of the study.
|
Parts 1 and 2: Dasiglucagon
n=12 participants at risk
Adverse events during administration of dasiglucagon during Parts 1 and 2 of the study.
|
Follow-up Period
n=1 participants at risk
Adverse events occurring during the Follow-up Period.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
Other adverse events
| Measure |
Part 1: Dasiglucagon
n=12 participants at risk
Adverse events during administration of dasiglucagon during Part 1 of the study.
|
Part 1: Placebo
n=12 participants at risk
Adverse events during administration of placebo during Part 1 of the study.
|
Part 2: Dasiglucagon
n=12 participants at risk
Adverse events during administration of dasiglucagon during Part 2 of the study.
|
Parts 1 and 2: Dasiglucagon
n=12 participants at risk
Adverse events during administration of dasiglucagon during Parts 1 and 2 of the study.
|
Follow-up Period
n=1 participants at risk
Adverse events occurring during the Follow-up Period.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 2 • 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.
|
0.00%
0/1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 2 • 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.
|
0.00%
0/1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/1 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
25.0%
3/12 • Number of events 3 • 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.
|
0.00%
0/1 • 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.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
100.0%
1/1 • Number of events 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.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
0.00%
0/1 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
16.7%
2/12 • Number of events 3 • 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.
|
0.00%
0/1 • 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.
|
|
Investigations
Alanine Aminotransferase Increased
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
0.00%
0/1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Finger Deformity
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
25.0%
3/12 • Number of events 3 • 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.
|
25.0%
3/12 • Number of events 3 • 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Acne Infantile
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Skin and subcutaneous tissue disorders
Sensitive Skin
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
100.0%
1/1 • Number of events 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
16.7%
2/12 • Number of events 3 • 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.
|
16.7%
2/12 • Number of events 3 • 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.
|
0.00%
0/1 • 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
16.7%
2/12 • Number of events 4 • 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.
|
16.7%
2/12 • Number of events 4 • 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.
|
0.00%
0/1 • 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.
|
|
Metabolism and nutrition disorders
Acidosis Hyperchloraemic
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 2 • 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.
|
8.3%
1/12 • Number of events 2 • 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.
|
0.00%
0/1 • 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.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
0.00%
0/1 • 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.
|
|
General disorders
Face Oedema
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
General disorders
Medical Device Site Reaction
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/1 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
25.0%
3/12 • Number of events 4 • 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.
|
25.0%
3/12 • Number of events 4 • 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.
|
0.00%
0/1 • 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.
|
|
Blood and lymphatic system disorders
Normocytic Anaemia
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Infections and infestations
Device Related Sepsis
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 2 • 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.
|
8.3%
1/12 • Number of events 2 • 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.
|
0.00%
0/1 • 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.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Eye disorders
Dry Eye
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma Of Liver
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
|
Product Issues
Device Occlusion
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 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.
|
8.3%
1/12 • Number of events 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.
|
0.00%
0/1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place