Clinical Trial Results:
A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Ibrexafungerp (SCY-078) in Adolescent Female Subjects
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Summary
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EudraCT number |
2024-000382-25 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
16 Dec 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Nov 2024
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First version publication date |
22 Nov 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SCY-078-120
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
SCYNEXIS, Inc.
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Sponsor organisation address |
1 Evertrust Plaza, 13th Floor, Jersey City, United States, 07302
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Public contact |
Regulatory Affairs, SCYNEXIS, Inc., info@scynexis.com
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Scientific contact |
Regulatory Affairs, SCYNEXIS, Inc., info@scynexis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-002535-PIP03-19 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Mar 2021
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Dec 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the plasma pharmacokinetics (PK) of ibrexafungerp in adolescent female subjects between 12 and 17 years old, after receiving one day of oral BID doses of ibrexafungerp.
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Protection of trial subjects |
The study was conducted in full compliance with the principles of the "Declaration of Helsinki" (as amended in Tokyo, Venice, Hong Kong, and South Africa), International Conference on Harmonization (ICH) guidelines, all of the applicable US Code of Federal Regulations (CFR), 21 CFR Part 50 & 312 and with applicable local requirements.
In obtaining and documenting informed consent and assent, the investigator was to comply with the applicable regulatory requirement(s) and was to adhere to Good Clinical Practices (GCP), local regulations, and to the ethical principles that have their origin in the Declaration of Helsinki. Prior to the beginning of the study, the investigator was to have the Independent Ethics Committees (IECs) written approval of the written informed consent/assent form and any other information provided to subjects.
Before undertaking any study-related procedures with subjects, the purpose and nature of the study as well as possible adverse events (AEs) were explained to them in understandable terms and written informed consent/assent was obtained from each individual. When feasible and appropriate for subject’s age, a vaginal swab sample may have been obtained for confirmation of Candida spp. infection via microscopic observation with 10% KOH. Obtaining a vaginal sample for 10% KOH analysis was not mandatory and the diagnosis of suspected Candida spp. vaginitis was enough for enrollment into the study if in the opinion of the investigator, the vaginitis would benefit from receipt of antifungal therapy. The vulvovaginal examination was age-appropriate and according to local practice.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Nov 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Mauritius: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
10
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 10 subjects were enrolled and randomized (Cohort A, aged 12 to 14 years: 4 subjects, Cohort B, aged 15 to 17 years: 6 subjects) and received investigational study medication. Ten (10) subjects (Cohort A: 4 subjects, Cohort B: 6 subjects) received all planned doses of study medication and completed all study procedures. | |||||||||
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Pre-assignment
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Screening details |
Within 1 week prior to dosing, subjects underwent a screening visit that included assessment of medical history, physical examination, vital signs, clinical laboratory testing, and an electrocardiogram (ECG). Eligible subjects had symptoms of vaginitis. Of the 10 participants screened all 10 were eligible to continue to enrolment in the study. | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
10 | |||||||||
Number of subjects completed |
10 | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cohort A (12 to 14 years of age) | |||||||||
Arm description |
Participants received one day of BID oral ibrexafungerp 300-mg (2 X 150-mg) citrate salt tablets given within 30 minutes of consuming a standard meal and 12 hours apart. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
ibrexafungerp
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Investigational medicinal product code |
SCY-078
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
BID dosing of 300mg ibrexafungerp tablets (as citrate salt). 2 x 150mg tablets.
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Arm title
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Cohort B (15 to 17 years of age) | |||||||||
Arm description |
Participants received one day of BID oral ibrexafungerp 300-mg (2 X 150-mg) citrate salt tablets given within 30 minutes of consuming a standard meal and 12 hours apart. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
ibrexafungerp
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Investigational medicinal product code |
SCY-078
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
BID dosing of 300mg ibrexafungerp tablets (as citrate salt). 2 x 150mg tablets.
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Baseline characteristics reporting groups
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Reporting group title |
Cohort A (12 to 14 years of age)
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Reporting group description |
Participants received one day of BID oral ibrexafungerp 300-mg (2 X 150-mg) citrate salt tablets given within 30 minutes of consuming a standard meal and 12 hours apart. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort B (15 to 17 years of age)
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Reporting group description |
Participants received one day of BID oral ibrexafungerp 300-mg (2 X 150-mg) citrate salt tablets given within 30 minutes of consuming a standard meal and 12 hours apart. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Pharmacokinetic Population
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects who receive ibrexafungerp and who have at least one quantifiable PK parameter.
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Subject analysis set title |
Safety Population
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects who enrolled in the study and received at least a partial tablet of ibrexafungerp. No treated subjects were excluded from the safety population.
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Subject analysis set title |
Enrolled Population
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects who were eligible and signed informed consent
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End points reporting groups
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Reporting group title |
Cohort A (12 to 14 years of age)
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Reporting group description |
Participants received one day of BID oral ibrexafungerp 300-mg (2 X 150-mg) citrate salt tablets given within 30 minutes of consuming a standard meal and 12 hours apart. | ||
Reporting group title |
Cohort B (15 to 17 years of age)
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Reporting group description |
Participants received one day of BID oral ibrexafungerp 300-mg (2 X 150-mg) citrate salt tablets given within 30 minutes of consuming a standard meal and 12 hours apart. | ||
Subject analysis set title |
Pharmacokinetic Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects who receive ibrexafungerp and who have at least one quantifiable PK parameter.
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Subject analysis set title |
Safety Population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who enrolled in the study and received at least a partial tablet of ibrexafungerp. No treated subjects were excluded from the safety population.
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Subject analysis set title |
Enrolled Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects who were eligible and signed informed consent
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End point title |
Maximum plasma concentration (Cmax) of ibrexafungerp following the first dose [1] | ||||||||||||||||
End point description |
Maximum plasma concentration of ibrexafungerp (Cmax), calculated by means of noncompartmental analysis, was one of the pharmacokinetic parameters evaluated in the study.
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End point type |
Primary
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End point timeframe |
Blood samples were collected predose (0 hours) and at 1, 2, 4, 8, and 12 (prior to the second dose) hours post first dose for determination of ibrexafungerp plasma concentrations.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were planned for this endpoint. Summary statistics for this parameter were described by n, arithmetic mean (mean), arithmetic mean SD, arithmetic CV%, geometric mean, geometric CV%, min, median, and max. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Maximum plasma concentration (Cmax) of ibrexafungerp following the second dose [2] | ||||||||||||||||
End point description |
Maximum plasma concentration of ibrexafungerp (Cmax), calculated by means of noncompartmental analysis, was one of the pharmacokinetic parameters evaluated in the study.
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End point type |
Primary
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End point timeframe |
Blood samples were collected at 13, 16, 24, 30, and 46 hours post first dose for determination of ibrexafungerp plasma concentrations.
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were planned for this endpoint. Summary statistics for this parameter were described by n, arithmetic mean (mean), arithmetic mean SD, arithmetic CV%, geometric mean, geometric CV%, min, median, and max. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Area under the concentration-time curve from 0 to 12 hours (AUC0-12) for ibrexafungerp [3] | ||||||||||||||||
End point description |
Area under the concentration-time curve (AUC0-12) was calculated by means of noncompartmental analysis. AUC determination was based on the linear trapezoidal rule, and actual PK sample times were used for the PK analyses.
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End point type |
Primary
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End point timeframe |
Blood samples were collected predose (0 hours) and at 1, 2, 4, 8, and 12 (prior to the second dose) hours post first dose for determination of ibrexafungerp plasma concentrations.
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were planned for this endpoint. Summary statistics for this parameter were described by n, arithmetic mean (mean), arithmetic mean SD, arithmetic CV%, geometric mean, geometric CV%, min, median, and max. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Area under the concentration-time curve from 12 to 24 hours (AUC12-24) for ibrexafungerp [4] | ||||||||||||||||
End point description |
Area under the concentration-time curve (AUC12-24) was calculated by means of noncompartmental analysis. AUC determination was based on the linear trapezoidal rule, and actual PK sample times were used for the PK analyses.
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End point type |
Primary
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End point timeframe |
Blood samples were collected at 12 (prior to the second dose), 13, 16 and 24 hours post first dose for determination of ibrexafungerp plasma concentrations.
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were planned for this endpoint. Summary statistics for this parameter were described by n, arithmetic mean (mean), arithmetic mean SD, arithmetic CV%, geometric mean, geometric CV%, min, median, and max. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Area under the concentration-time curve from 12 hours to infinity (AUC12-∞) for ibrexafungerp [5] | ||||||||||||||||
End point description |
Area under the concentration-time curve (AUC12-∞) was calculated by means of noncompartmental analysis. AUC determination was based on the linear trapezoidal rule, and actual PK sample times were used for the PK analyses. The AUC from the last measurable concentration (Clast) to infinity (AUCt-∞) was calculated as Clast/λz. If the calculated AUCt-∞ (extrapolated AUC, where t was 12 hours) was greater than 20% of the calculated value of AUC0-∞, then only AUC12-24 was reported.
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End point type |
Primary
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End point timeframe |
Blood samples were collected at 12 (prior to the second dose), 13, 16, 24, 30, and 46 hours post first dose for determination of ibrexafungerp plasma concentrations.
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were planned for this endpoint. Summary statistics for this parameter were described by n, arithmetic mean (mean), arithmetic mean SD, arithmetic CV%, geometric mean, geometric CV%, min, median, and max. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Time to maximum plasma concentration (Tmax) of ibrexafungerp after the first dose [6] | ||||||||||||||||
End point description |
Time to maximum plasma concentration (Tmax) of ibrexafungerp was calculated by means of noncompartmental analysis.
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End point type |
Primary
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End point timeframe |
Blood samples were collected predose (0 hours) and at 1, 2, 4, 8, and 12 (prior to the second dose) hours post first dose for determination of ibrexafungerp plasma concentrations.
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were planned for this endpoint. Summary statistics for this parameter were described by n, median, min, and max. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Time to maximum plasma concentration (Tmax) of ibrexafungerp after the second dose [7] | ||||||||||||||||
End point description |
Time to maximum plasma concentration (Tmax) of ibrexafungerp was calculated by means of noncompartmental analysis.
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End point type |
Primary
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End point timeframe |
Blood samples were collected at 13, 16, 24, 30, and 46 hours post first dose for determination of ibrexafungerp plasma concentrations.
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were planned for this endpoint. Summary statistics for this parameter were described by n, median, min, and max. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Elimination half-life (t½) of ibrexafungerp after the second dose [8] | ||||||||||||||||
End point description |
Elimination half-life (t½) of ibrexafungerp after the second dose was calculated by means of noncompartmental analysis (NCA). Elimination rate constants were based on the linear trapezoidal rule, and actual PK sample times were used for the PK analyses. The t½, if calculated, used at least 3 time points from the logarithmic terminal phase portion of the concentration time curve. If the adjusted R-squared value (Rsq_adjusted) was <0.8 for the determination of the elimination rate constant, then PK parameters depending upon Kel (λz) were not reported (ie, t½, AUCt-∞).
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End point type |
Primary
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End point timeframe |
Blood samples were collected predose (0 hours) and at 1, 2, 4, 8, 12 (prior to the second dose), 13, 16, 24, 30, and 46 hours post first dose for determination of ibrexafungerp plasma concentrations.
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were planned for this endpoint. Summary statistics for this parameter were described by n, arithmetic mean (mean), arithmetic mean SD, arithmetic CV%, geometric mean, geometric CV%, min, median, and max. The t½, harmonic mean, and pseudo SD were also presented. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Safety and tolerability of ibrexafungerp after receiving one day of BID dosing | ||||||||||||
End point description |
Safety and tolerability was measured by adverse events, vital signs (blood pressure, heart rate, respiratory rate, and temperature), physical examination, 12-lead electrocardiogram (ECG), and laboratory safety (biochemistry, hematology, coagulation, and urinalysis).
Adverse events were collected from the time of ascent and informed consent through 30 days after the last dose of study medication, a phone call was made to find out if there had been any AEs after the TOC/poststudy visit.
Vital signs were measured at screening, on Day 1 at predose, at 2, 4, 13, 16, 24 and 30 hours post AM dose, and the poststudy visit.
Physical exams were performed at screening and then at predose (if screening was more than 24 hours predose Day 1), 24 hours post AM dose Day 1, and the poststudy visit
A 12-lead ECG was conducted at screening, 30 hours post first dose and at the poststudy visit.
Laboratory safety tests were conducted at screening, 46 hours post first dose and at the poststudy visit.
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End point type |
Secondary
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End point timeframe |
Adverse events and measurements were taken throughout the study duration.
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Attachments |
Untitled (Filename: Tabluated Summary of Safety Parameters.pdf) |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Efficacy of ibrexafungerp in the treatment of suspected candida spp. vaginitis in adolescent girls | ||||||
End point description |
The Test of Cure (TOC) exploratory endpoint of the study was to assess the efficacy of ibrexafungerp in the treatment of suspected Candida spp. vaginitis in adolescent females with symptoms and signs of vaginitis consistent with vulvovaginal candidiasis as reported by the resolution of baseline symptoms at the Day 10 (TOC) visit. The composite score of the vulvovaginal signs and symptoms was calculated by adding the signs and symptoms scores for each subject and had a total possible score of 0 to 18. The efficacy analysis was performed for the VSS scores collected at screening, predose, and at the TOC visit. Clinical cure was defined as a composite VSS score of zero at the TOC visit.
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End point type |
Other pre-specified
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End point timeframe |
Poststudy visit (Day 10 ± 3)
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events (AEs) were collected from the time of assent and informed consent through 30 days after the last dose of study medication, a phone call was made to find out if there had been any AEs after the TOC/poststudy visit.
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Adverse event reporting additional description |
Summary tables of treatment-emergent AEs (TEAE) are presented. A TEAE is defined as any AE with an onset date and time after the first dose of study drug or any event already present that worsens in severity after exposure to the treatment. A subject with more than one TEAE within a SOC (or PT) was counted only once for that SOC (or PT)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.0
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Reporting groups
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Reporting group title |
Cohort A (12 to 14 years of age)
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Reporting group description |
Participants received one day of BID oral ibrexafungerp 300-mg (2 X 150-mg) citrate salt tablets given within 30 minutes of consuming a standard meal and 12 hours apart. | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort B (15 to 17 years of age)
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Reporting group description |
Participants received one day of BID oral ibrexafungerp 300-mg (2 X 150-mg) citrate salt tablets given within 30 minutes of consuming a standard meal and 12 hours apart. | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Enrolled Population
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
