Trial Outcomes & Findings for An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE (NCT NCT04912856)
NCT ID: NCT04912856
Last Updated: 2025-02-14
Results Overview
Safety and tolerability of XEN496 as assessed by incidence and severity of AEs and SAEs
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
8 participants
Primary outcome timeframe
From Screening/Baseline through to 4 weeks post last dose
Results posted on
2025-02-14
Participant Flow
Participant milestones
| Measure |
Group 1: XEN496 Treatment in Preceding Study
24-day blinded transition/titration period. Subjects who received XEN496 in the preceding study will continue to receive XEN496 at the same dose, in a blinded manner, without any further titration. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Optimally-tolerated dose level established during the transition/titration period will be maintained throughout the duration of open-label period unless dose adjustment is required.
Subjects who discontinue will be required to taper off study drug over a period of up to 15 days
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
Placebo: Placebo sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
Group 2: Placebo Treatment in Preceding Study
24-day blinded transition/titration period. Subjects, who were allocated to placebo in the preceding study, will be titrated to a tolerated dose up to a maximum dose of 21 mg/kg/day, with a maximum daily dose of 672 mg/day. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Optimally-tolerated dose level established during the transition/titration period will be maintained throughout the duration of open-label period unless dose adjustment is required.
Subjects who discontinue will be required to taper off study drug over a period of up to 15 days
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
Placebo: Placebo sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Group 1: XEN496 Treatment in Preceding Study
24-day blinded transition/titration period. Subjects who received XEN496 in the preceding study will continue to receive XEN496 at the same dose, in a blinded manner, without any further titration. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Optimally-tolerated dose level established during the transition/titration period will be maintained throughout the duration of open-label period unless dose adjustment is required.
Subjects who discontinue will be required to taper off study drug over a period of up to 15 days
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
Placebo: Placebo sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
Group 2: Placebo Treatment in Preceding Study
24-day blinded transition/titration period. Subjects, who were allocated to placebo in the preceding study, will be titrated to a tolerated dose up to a maximum dose of 21 mg/kg/day, with a maximum daily dose of 672 mg/day. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Optimally-tolerated dose level established during the transition/titration period will be maintained throughout the duration of open-label period unless dose adjustment is required.
Subjects who discontinue will be required to taper off study drug over a period of up to 15 days
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
Placebo: Placebo sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
|---|---|---|
|
Overall Study
Sponsor Decision; not due to safety reasons
|
4
|
2
|
|
Overall Study
Not reported in synoptic CSR.
|
0
|
1
|
Baseline Characteristics
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
Baseline characteristics by cohort
| Measure |
Group 1: XEN496 Treatment in Preceding Study
n=5 Participants
24-day blinded transition/titration period. Subjects who received XEN496 in the preceding study will continue to receive XEN496 at the same dose, in a blinded manner, without any further titration. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Subjects who discontinue will be required to taper off study drug over a period of up to 15 days
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
Group 2: Placebo Treatment in Preceding Study
n=3 Participants
24-day blinded transition/titration period. Subjects, who were allocated to placebo in the preceding study, will be titrated to a tolerated dose up to a maximum dose of 21 mg/kg/day, with a maximum daily dose of 672 mg/day. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Optimally-tolerated dose level established during the transition/titration period will be maintained throughout the duration of open-label period unless dose adjustment is required.
Subjects who discontinue or complete the study treatment will be required to taper off study drug over a period of up to 15 days.
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Screening/Baseline through to 4 weeks post last doseSafety and tolerability of XEN496 as assessed by incidence and severity of AEs and SAEs
Outcome measures
| Measure |
Group 1: XEN496 Treatment in Preceding Study
n=5 Participants
24-day blinded transition/titration period. Subjects who received XEN496 in the preceding study will continue to receive XEN496 at the same dose, in a blinded manner, without any further titration. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Subjects who discontinue will be required to taper off study drug over a period of up to 15 days
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
Group 2: Placebo Treatment in Preceding Study
n=3 Participants
24-day blinded transition/titration period. Subjects, who were allocated to placebo in the preceding study, will be titrated to a tolerated dose up to a maximum dose of 21 mg/kg/day, with a maximum daily dose of 672 mg/day. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Optimally-tolerated dose level established during the transition/titration period will be maintained throughout the duration of open-label period unless dose adjustment is required.
Subjects who discontinue or complete the study treatment will be required to taper off study drug over a period of up to 15 days.
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
|---|---|---|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Intervention
Number of participants with any AEs
|
5 Participants
|
3 Participants
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Intervention
Number of participants with any TEAE
|
5 Participants
|
3 Participants
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Intervention
Participants with any treatment related TEAE
|
1 Participants
|
2 Participants
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Intervention
Participants with any TEAE leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Intervention
Participants with any TEAE leading to a dose reduction or treatment interruption
|
1 Participants
|
1 Participants
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Intervention
Participants with any Severe TEAE
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Intervention
Participants with any Serious TEAE
|
2 Participants
|
1 Participants
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Intervention
Participants with any TEAE leading to death
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: XEN496 Treatment in Preceding Study
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2: Placebo Treatment in Preceding Study
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: XEN496 Treatment in Preceding Study
n=5 participants at risk
24-day blinded transition/titration period. Subjects who received XEN496 in the preceding study will continue to receive XEN496 at the same dose, in a blinded manner, without any further titration. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Subjects who discontinue will be required to taper off study drug over a period of up to 15 days
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
Group 2: Placebo Treatment in Preceding Study
n=3 participants at risk
24-day blinded transition/titration period. Subjects, who were allocated to placebo in the preceding study, will be titrated to a tolerated dose up to a maximum dose of 21 mg/kg/day, with a maximum daily dose of 672 mg/day. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Optimally-tolerated dose level established during the transition/titration period will be maintained throughout the duration of open-label period unless dose adjustment is required.
Subjects who discontinue or complete the study treatment will be required to taper off study drug over a period of up to 15 days.
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Nervous system disorders
Seizure cluster
|
20.0%
1/5 • Number of events 2 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Gastrointestinal disorders
Intestinal malrotation
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
Other adverse events
| Measure |
Group 1: XEN496 Treatment in Preceding Study
n=5 participants at risk
24-day blinded transition/titration period. Subjects who received XEN496 in the preceding study will continue to receive XEN496 at the same dose, in a blinded manner, without any further titration. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Subjects who discontinue will be required to taper off study drug over a period of up to 15 days
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
Group 2: Placebo Treatment in Preceding Study
n=3 participants at risk
24-day blinded transition/titration period. Subjects, who were allocated to placebo in the preceding study, will be titrated to a tolerated dose up to a maximum dose of 21 mg/kg/day, with a maximum daily dose of 672 mg/day. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects.
Optimally-tolerated dose level established during the transition/titration period will be maintained throughout the duration of open-label period unless dose adjustment is required.
Subjects who discontinue or complete the study treatment will be required to taper off study drug over a period of up to 15 days.
XEN496: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
|
|---|---|---|
|
Renal and urinary disorders
Urinary retention
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Eye disorders
Retinal Pigmentation
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Investigations
Blood pressure systolic increased
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Infections and infestations
Gastroenteritis
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
General disorders
Peripheral swelling
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
General disorders
Swelling face
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
1/5 • Number of events 2 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
General disorders
Pyrexia
|
40.0%
2/5 • Number of events 2 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Infections and infestations
Otitis Media
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Investigations
Respiratory synctial virus test positive
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Congenital, familial and genetic disorders
Intestinal malrotation
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
20.0%
1/5 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
0.00%
0/3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Gastrointestinal disorders
Blood in the stool
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
66.7%
2/3 • Number of events 3 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
66.7%
2/3 • Number of events 2 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Psychiatric disorders
Initial Insomnia
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Ear and labyrinth disorders
Ear Swelling
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/5 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
33.3%
1/3 • Number of events 1 • Collection of adverse event data began at Visit 1 when consent was obtained and continued throughout the course subject's participation in the study. The intended duration of the collection period was 3 years. Following the termination of the study, the collection period was up to 2 years and 3 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60