Trial Outcomes & Findings for Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy (NCT NCT03222349)
NCT ID: NCT03222349
Last Updated: 2021-05-26
Results Overview
AUC calculated from time 0 (dosing) to 4 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Time 0 (dosing), 0.25, 0.5, 1, 1.5, 2, 4 hours post-dose
Results posted on
2021-05-26
Participant Flow
Planned enrollment was 24 male and female subjects with 8 subjects in each of 3 age ranges (2 to 5 years, 6 to 11 years, and 12 to 16 years) with a clinical diagnosis of epilepsy (generalized tonic clonic seizures or focal seizures with impaired awareness) currently receiving at least one epileptic medication who were scheduled for admission to an Epilepsy Monitoring Unit (EMU), General Clinical Research Center (GCRC), or similar facility for evaluation.
A total of 24 subjects were enrolled and received at least 1 dose of study drug based on age and weight during the interictal and the ictal/peri-ictal period in either order as determined by seizure occurrence.
Participant milestones
| Measure |
Interictal State, Then Ictal/Peri-ictal State
The interictal state was defined as a period of time during which 3 hours had elapsed since any clinical postictal signs or symptoms (from the last observed seizure). If clinical and/or electroencephalogram monitoring showed no seizure activity, the subject received DBF single dose determined by age and body weight.
|
Ictal/Peri-ictal State, Then Interictal State
The ictal/peri-ictal state was defined as an ongoing clinically observable seizure or seizure activity as verified via EEG. The peri-ictal state was defined as the subject's immediate postictal state following a generalized tonic-clonic (GTC) seizure or focal seizure with impaired awareness, and within 5 minutes after the last clonic jerk. For subjects on EEG monitoring, the peri-ictal state could be defined as less than 5 minutes after cessation of seizure activity (GTC or focal seizure with impaired awareness) as verified via EEG.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Interictal State, Then Ictal/Peri-ictal State
The interictal state was defined as a period of time during which 3 hours had elapsed since any clinical postictal signs or symptoms (from the last observed seizure). If clinical and/or electroencephalogram monitoring showed no seizure activity, the subject received DBF single dose determined by age and body weight.
|
Ictal/Peri-ictal State, Then Interictal State
The ictal/peri-ictal state was defined as an ongoing clinically observable seizure or seizure activity as verified via EEG. The peri-ictal state was defined as the subject's immediate postictal state following a generalized tonic-clonic (GTC) seizure or focal seizure with impaired awareness, and within 5 minutes after the last clonic jerk. For subjects on EEG monitoring, the peri-ictal state could be defined as less than 5 minutes after cessation of seizure activity (GTC or focal seizure with impaired awareness) as verified via EEG.
|
|---|---|---|
|
Overall Study
Treatment B not done
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Treatment A not done
|
0
|
5
|
|
Overall Study
Study terminated by sponsor
|
1
|
0
|
Baseline Characteristics
Pediatric patients with epilepsy in three age ranges (2-5 years, 6-11 years, 12-16 years) who received at least 1 dose of DBF determined by age and weight
Baseline characteristics by cohort
| Measure |
Safety Analysis Set
n=24 Participants
A total of 24 subjects were enrolled and received at least 1 dose of DBF determined based on age and weight (6 in the 2-5 years age group, 9 in the 6-11 years age group, and 9 in the 12-16 years age group).
|
|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=93 Participants • Pediatric patients with epilepsy in three age ranges (2-5 years, 6-11 years, 12-16 years) who received at least 1 dose of DBF determined by age and weight
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants • Pediatric patients with epilepsy in three age ranges (2-5 years, 6-11 years, 12-16 years) who received at least 1 dose of DBF determined by age and weight
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants • Pediatric patients with epilepsy in three age ranges (2-5 years, 6-11 years, 12-16 years) who received at least 1 dose of DBF determined by age and weight
|
|
Age, Continuous
|
14.0 years
STANDARD_DEVIATION 1.58 • n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=93 Participants
|
|
Body Mass Index (kg/m^2)
|
22.166 kg/m^2
STANDARD_DEVIATION 10.1980 • n=93 Participants
|
PRIMARY outcome
Timeframe: Time 0 (dosing), 0.25, 0.5, 1, 1.5, 2, 4 hours post-dosePopulation: Subjects in the Pharmacokinetics Population who had data following dosing in both the Interictal State and the Ictal/Peri-ictal State
AUC calculated from time 0 (dosing) to 4 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Outcome measures
| Measure |
Interictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).
Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
Ictal/Peri-ictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
|---|---|---|
|
Area Under the Concentration Time Curve (AUC) 0 to 4 Hours Post-dose
|
739.33 hr*ng/mL
Standard Deviation 312.06
|
585 hr*ng/mL
Standard Deviation 377.11
|
PRIMARY outcome
Timeframe: Time 0 (dosing), 0.25, 0.5, 1, 1.5, 2 hours post-dosePopulation: Subjects in the Pharmacokinetics Population who had data following dosing in both the Interictal State and the Ictal/Peri-ictal State
AUC calculated from time 0 (dosing) to 2 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Outcome measures
| Measure |
Interictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).
Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
Ictal/Peri-ictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
|---|---|---|
|
Area Under the Concentration Time Curve (AUC) From 0 to 2 Hours Post-dose
|
394.63 hr*ng/mL
Standard Deviation 192.47
|
309.34 hr*ng/mL
Standard Deviation 210.39
|
PRIMARY outcome
Timeframe: Time 0 (dosing), 0.25, 0.5, 1, 1.5, 2 hours post-dosePopulation: Subjects in the Pharmacokinetics Population who had data following dosing in both the Interictal State and the Ictal/Peri-ictal State
Tmax calculated from time 0 (dosing) to 2 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Outcome measures
| Measure |
Interictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).
Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
Ictal/Peri-ictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
|---|---|---|
|
Time When Maximum Plasma Concentration Was Observed (Tmax) 0 to 2 Hours Post-dose
|
1.196 hours
Standard Deviation 0.754
|
0.861 hours
Standard Deviation 0.574
|
PRIMARY outcome
Timeframe: Time 0 (dosing), 0.25, 0.5, 1, 1.5, 2, 4 hours post-dosePopulation: Subjects in the Pharmacokinetics Population who had data following dosing in both the Interictal State and the Ictal/Peri-ictal State
Tmax calculated from dosing (Time 0) to 4 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Outcome measures
| Measure |
Interictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).
Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
Ictal/Peri-ictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
|---|---|---|
|
Time When Maximum Plasma Concentration Was Observed (Tmax) 0-4 Hours Post-Dose
|
1.196 hours
Standard Deviation 0.754
|
0.861 hours
Standard Deviation 0.574
|
PRIMARY outcome
Timeframe: Time 0 (dosing), 0.25, 0.5, 1, 1.5, 2 hours post-dosePopulation: Subjects in the Pharmacokinetics Population who had data following dosing in both the Interictal State and the Ictal/Peri-ictal State
Maximum observed plasma concentration measured from Time 0 to 2 hours post-dose in Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Outcome measures
| Measure |
Interictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).
Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
Ictal/Peri-ictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
|---|---|---|
|
Observed Maximum Plasma Concentration (Cmax) 0-2 Hours
|
296.64 ng/mL
Standard Deviation 152.82
|
233.50 ng/mL
Standard Deviation 141.92
|
PRIMARY outcome
Timeframe: Time 0 (dosing), 0.25, 0.5, 1, 1.5, 2, 4 hours post-dosePopulation: Subjects in the Pharmacokinetics Population who had data following dosing in both the Interictal State and the Ictal/Peri-ictal State
Maximum observed plasma concentration from Time 0 to 4 hours post-dose in Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Outcome measures
| Measure |
Interictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).
Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
Ictal/Peri-ictal State
n=8 Participants
Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
|---|---|---|
|
Observed Maximum Plasma Concentration (Cmax) From Time 0 (Dosing) to 4 Hours Post-dose
|
296.64 ng/mL
Standard Deviation 152.82
|
233.50 ng/mL
Standard Deviation 141.92
|
SECONDARY outcome
Timeframe: Period A and Period B from the time of first attempt at DBF insertion to 15 minutes after insertion.Population: The safety population comprising all subjects who received at least 1 dose of the study drug in the given study period.
Was DBF spit out or blown out by the subject after adherence to the buccal mucosa or did the subject chew, talk or move the DBF prior to complete disintegration/dissolution?
Outcome measures
| Measure |
Interictal State
n=17 Participants
Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).
Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
Ictal/Peri-ictal State
n=16 Participants
Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
|---|---|---|
|
Usability of Diazepam Buccal Film: Number of Subjects Who Spit Out/Moved/Chewed the Film After it Adhered (Stuck) to Buccal Mucosa During Period A and Period B.
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Period A and Period B from the time of first attempt at DBF insertion to 15 minutes after insertion.Population: The safety population comprising all subjects who received at least 1 dose of the study drug in the given study period.
Number of subjects with any unsuccessful DBF insertion attempts (All analyzed subjects with an unsuccessful attempt ultimately had a successful attempt at dosing)
Outcome measures
| Measure |
Interictal State
n=17 Participants
Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).
Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
Ictal/Peri-ictal State
n=16 Participants
Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
|---|---|---|
|
Usability of Diazepam Buccal Film: Unsuccessful Attempts
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Period A and Period B from the time of first attempt at DBF insertion to 15 minutes after insertion.Population: The safety population comprising all subjects who received at least 1 dose of the study drug in the given study period.
Estimation of the amount of saliva exiting the mouth in mL after DBF dosing in Period A and Period B
Outcome measures
| Measure |
Interictal State
n=17 Participants
Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).
Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
Ictal/Peri-ictal State
n=16 Participants
Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
|---|---|---|
|
Usability Endpoint : Amount of Saliva That Exited the Mouth After DBF Dosing
Participants with 0 mL saliva exiting the mouth
|
13 Participants
|
15 Participants
|
|
Usability Endpoint : Amount of Saliva That Exited the Mouth After DBF Dosing
Participants with > 0 mL to ≤ 1 mL saliva exiting the mouth
|
0 Participants
|
1 Participants
|
|
Usability Endpoint : Amount of Saliva That Exited the Mouth After DBF Dosing
Participants with > 1 mL to ≤ 2 mL saliva exiting the mouth
|
2 Participants
|
0 Participants
|
|
Usability Endpoint : Amount of Saliva That Exited the Mouth After DBF Dosing
Participants with > 2 mL to ≤ 3 mL saliva exiting the mouth
|
1 Participants
|
0 Participants
|
|
Usability Endpoint : Amount of Saliva That Exited the Mouth After DBF Dosing
Participants with no data reported or unknown
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Period A and Period B from the time of first attempt at DBF insertion to 15 minutes after insertion.Population: The safety population comprising all subjects who received at least 1 dose of the study drug.
Number of subjects who swallowed DBF during Period A and/or Period B
Outcome measures
| Measure |
Interictal State
n=17 Participants
Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).
Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
Ictal/Peri-ictal State
n=16 Participants
Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
|
|---|---|---|
|
Number of Subjects Who Swallowed DBF After Initial Insertion
|
2 Participants
|
1 Participants
|
Adverse Events
Interictal Period (Period A)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ictal/Peri-ictal Period (Period B)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Interictal Period (Period A)
n=17 participants at risk
Each subject received a single dose of DBF based on the subject's age and weight.
Diazepam Buccal Film: Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses.
|
Ictal/Peri-ictal Period (Period B)
n=16 participants at risk
Each subject received a single dose of DBF based on the subject's age and weight.
Diazepam Buccal Film: Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses.
|
|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/17 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Nervous system disorders
Seizure cluster
|
0.00%
0/17 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
Other adverse events
| Measure |
Interictal Period (Period A)
n=17 participants at risk
Each subject received a single dose of DBF based on the subject's age and weight.
Diazepam Buccal Film: Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses.
|
Ictal/Peri-ictal Period (Period B)
n=16 participants at risk
Each subject received a single dose of DBF based on the subject's age and weight.
Diazepam Buccal Film: Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses.
|
|---|---|---|
|
Nervous system disorders
Seizure
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
18.8%
3/16 • Number of events 10 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Number of events 2 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
0.00%
0/16 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
General disorders
Petit mal epilepsy
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Nervous system disorders
Generalized tonic-clonic seizure
|
0.00%
0/17 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
6.2%
1/16 • Number of events 5 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Nervous system disorders
Myoclonic epilepsy
|
0.00%
0/17 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
0.00%
0/16 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Infections and infestations
Upper respiratory tract infection
|
11.8%
2/17 • Number of events 2 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
0.00%
0/16 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
General disorders
Pyexia
|
11.8%
2/17 • Number of events 2 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 4 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
0.00%
0/16 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
0.00%
0/16 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
0.00%
0/16 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from the time of informed consent through 14 days +/- 2 days after dosing
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60