Trial Outcomes & Findings for A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients (NCT NCT03976076)
NCT ID: NCT03976076
Last Updated: 2024-08-22
Results Overview
TEAEs were defined as any event that did not present before exposure to the investigational product (IP) or any event already present that worsened in either intensity or frequency after exposure to the IP.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Day 1 to Day 56
Results posted on
2024-08-22
Participant Flow
All eligible patients (met all the inclusion and none of the exclusion criteria) whose legal representative (parent\[s\]/caregiver\[s\]) provided a written informed consent were enrolled in the study and entered the treatment period on Day 1. Patients were recruited from 15 April 2020 to 10 Dec 2021 for this study.
An overnight video-EEG was completed within the Screening Period (Days -28 to -6) and repeated at Day 28 (Visit 5 \[± 2 days\]), following Treatment Period 1 for assessment of spasms and hypsarrhythmia. Sixteen participants were actually enrolled, of whom 12 participants were treated. Four patients were screen failures; (2 patients failed to meet the inclusion/exclusion criteria and 2 patients were screen failed due to the other reasons).
Participant milestones
| Measure |
JBPOS0101 (Investigational Product)
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6mg/kg, per oral (PO), twice a day (BID), once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the Investigational Product (JBPOS0101) (IP) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
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|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
JBPOS0101 (Investigational Product)
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6mg/kg, per oral (PO), twice a day (BID), once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the Investigational Product (JBPOS0101) (IP) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
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|---|---|
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Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients
Baseline characteristics by cohort
| Measure |
JBPOS0101 (Investigational Product)
n=12 Participants
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6mg/kg, PO, BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the IP (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
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|---|---|
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Age, Continuous
|
19.93 Months
STANDARD_DEVIATION 8.373 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 56Population: Safety Population: Included all patients who were treated with at least one dose of the IP.
TEAEs were defined as any event that did not present before exposure to the investigational product (IP) or any event already present that worsened in either intensity or frequency after exposure to the IP.
Outcome measures
| Measure |
JBPOS0101 (Investigational Product)
n=12 Participants
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, twice a BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the IP (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
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|---|---|
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
12 Participants
|
SECONDARY outcome
Timeframe: 0.5 to1.5 hours post morning (AM) dose on Day 1Population: PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration.
Pharmacokinetics: JBPOS0101 plasma concentration 0.5 - 1.5 hours post morning dose on Day 1
Outcome measures
| Measure |
JBPOS0101 (Investigational Product)
n=12 Participants
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, twice a BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the IP (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
|
|---|---|
|
JBPOS0101 Plasma Concentration 0.5 - 1.5 Hours Post Morning Dose, Day 1
|
6150.0 Nanograms per milliliter (ng/mL)
Standard Deviation 1845.45
|
SECONDARY outcome
Timeframe: 4 to 6 hours post morning (AM) dose on Day 1Population: PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration.
Pharmacokinetics: JBPOS0101 plasma concentration 4 - 6 hours post morning dose on Day 1
Outcome measures
| Measure |
JBPOS0101 (Investigational Product)
n=12 Participants
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, twice a BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the IP (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
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|---|---|
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JBPOS0101 Plasma Concentration 4-6 Hours Post Morning Dose, Day 1
|
5854.2 ng/mL
Standard Deviation 904.85
|
SECONDARY outcome
Timeframe: 8 hours post morning (AM) dose and pre-PM dose on Day 1Population: PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. Here N=12 is the overall number of participants. n= 11 signifies number of participants with available data for specified time.
Pharmacokinetics: JBPOS0101 plasma concentration 8 hours post morning dose and pre-PM dose on Day 1.
Outcome measures
| Measure |
JBPOS0101 (Investigational Product)
n=11 Participants
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, twice a BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the IP (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
|
|---|---|
|
JBPOS0101 Plasma Concentration 8 Hours Post Morning Dose and Pre-PM Dose, Day 1
|
4172.7 ng/mL
Standard Deviation 765.13
|
SECONDARY outcome
Timeframe: 0.5 to1.5 hours post morning (AM) dose on Day 21Population: PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. Here N=12 is the overall number of participants. n= 11 signifies number of participants with available data for specified time.
Pharmacokinetics: JBPOS0101 plasma concentration 0.5 - 1.5 hours post morning dose on Day 21
Outcome measures
| Measure |
JBPOS0101 (Investigational Product)
n=11 Participants
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, twice a BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the IP (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
|
|---|---|
|
JBPOS0101 Plasma Concentration 0.5 -1.5 Hours Post Morning Dose, Day 21
|
22945.5 ng/mL
Standard Deviation 3599.27
|
SECONDARY outcome
Timeframe: 4 to 6 hours post morning (AM) dose on Day 21Population: PK population: PK Population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. Here N=12 is the overall number of participants. n= 10 signifies number of participants with available data for specified time.
Pharmacokinetics: JBPOS0101 plasma concentration 4 - 6 hours post morning dose on Day 21
Outcome measures
| Measure |
JBPOS0101 (Investigational Product)
n=10 Participants
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, twice a BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the IP (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
|
|---|---|
|
JBPOS0101 Plasma Concentration 4 - 6 Hours Post Morning Dose, Day 21
|
18070.0 ng/mL
Standard Deviation 4184.11
|
SECONDARY outcome
Timeframe: 8 hours post morning (AM) dose and pre-PM dose on Day 21Population: PK population: PK Population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. Here N=12 is the overall number of participants. n= 9 signifies number of participants with available data for specified time.
Pharmacokinetics: JBPOS0101 plasma concentration 8 hours post morning dose and pre-PM dose on Day 21.
Outcome measures
| Measure |
JBPOS0101 (Investigational Product)
n=9 Participants
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, twice a BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the IP (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
|
|---|---|
|
JBPOS0101 Plasma Concentration 8 Hours Post Morning Dose and Pre-PM Dose, Day 21
|
12921.1 ng/mL
Standard Deviation 3220.22
|
SECONDARY outcome
Timeframe: Day 1Population: PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. Here N=12 is the overall number of participants. n= 10 signifies number of participants with available data for specified time.
Pharmacokinetics: JBPOS0101 urine concentration on Day 1. Urine samples were collected following the morning dose.
Outcome measures
| Measure |
JBPOS0101 (Investigational Product)
n=10 Participants
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, twice a BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the IP (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
|
|---|---|
|
JBPOS0101 Urine Concentration at Day 1
|
3410.0 ng/mL
Standard Deviation 1152.50
|
SECONDARY outcome
Timeframe: Day 21Population: PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. Here N=12 is the overall number of participants. n= 9 signifies number of participants with available data for specified time.
Pharmacokinetics: JBPOS0101 urine concentration on Day 21. Urine samples were collected following the morning dose.
Outcome measures
| Measure |
JBPOS0101 (Investigational Product)
n=9 Participants
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, twice a BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the IP (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was100 mg, white to off-white powder for reconstitution into an oral solution.
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|---|---|
|
JBPOS0101 Urine Concentrations at Day 21
|
14360.0 ng/mL
Standard Deviation 6986.77
|
Adverse Events
JBPOS0101 (Investigational Product)
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JBPOS0101 (Investigational Product)
n=12 participants at risk
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the Investigational Product (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was 100 mg, white to off-white powder for reconstitution into an oral solution.
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|---|---|
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Investigations
Liver function test increased
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
Other adverse events
| Measure |
JBPOS0101 (Investigational Product)
n=12 participants at risk
JBPOS0101: JBPOS0101 (investigational product)
During Treatment Period 1, the IP was administered at 6 mg/kg, PO, BID, once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the Investigational Product (JBPOS0101) at a dose of 9 mg/kg orally BID. Starting on Day15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing. IP was 100 mg, white to off-white powder for reconstitution into an oral solution.
|
|---|---|
|
Nervous system disorders
Somnolence
|
25.0%
3/12 • Number of events 3 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Nervous system disorders
Sedation
|
16.7%
2/12 • Number of events 4 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Investigations
Liver function test increased
|
16.7%
2/12 • Number of events 2 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Investigations
Electrocardiogram QT prolonged
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.3%
1/12 • Number of events 2 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Psychiatric disorders
Abnormal behaviour
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Psychiatric disorders
Irritability
|
16.7%
2/12 • Number of events 2 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Injury, poisoning and procedural complications
Sedation complication
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Renal and urinary disorders
Urine odour abnormal
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Nervous system disorders
Drooling
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • Number of events 2 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
2/12 • Number of events 2 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 2 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • Number of events 2 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
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Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Number of events 2 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Infections and infestations
Otitis media acute
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Number of events 1 • Day 1 to Day 56.
Adverse event analyses were conducted on the safety population. A treatment-emergent adverse event (TEAE) was defined as any AE that began or worsened following the start of dosing of Treatment Period 1, Day 1 to Follow-Up. NOTE: Seizure (SAE) and aspiration pneumonia (SAE) were not related to IP. The investigator noted for the TEAE "Electrocardiogram QT prolonged" that the patient was distressed and crying to the point of hyperventilation.
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Additional Information
Bio-Pharm Solutions Medical Information
Bio-Pharm Solutions Co., Ltd.
Phone: NA
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER