Clinical Trial Results:
Long-term, open-label, flexible-dose, continuation extension study with vortioxetine in child and adolescent patients with Major Depressive Disorder (MDD) from 7 to 17 years of age
|
Summary
|
|
EudraCT number |
2015-002658-11 |
Trial protocol |
BE GB LV HU EE ES IT DE BG PL FR |
Global end of trial date |
16 Apr 2020
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
21 Oct 2020
|
First version publication date |
21 Oct 2020
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
12712B
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT03108625 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
H. Lundbeck A/S
|
||
Sponsor organisation address |
Ottiliavej 9, Valby, Denmark, 2500
|
||
Public contact |
Lundbeck Clinical Trials, H. Lundbeck A/S, +45 36 3013 11, LundbeckClinicalTrials@lundbeck.com
|
||
Scientific contact |
Lundbeck Clinical Trials, H. Lundbeck A/S, +45 36 3013 11, LundbeckClinicalTrials@lundbeck.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
|
||
EMA paediatric investigation plan number(s) |
EMEA-000455-PIP02-10 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
16 Apr 2020
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
16 Apr 2020
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
16 Apr 2020
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.
|
||
Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996)
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Jan 2017
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Spain: 4
|
||
Country: Number of subjects enrolled |
Poland: 18
|
||
Country: Number of subjects enrolled |
United Kingdom: 1
|
||
Country: Number of subjects enrolled |
Bulgaria: 11
|
||
Country: Number of subjects enrolled |
Estonia: 7
|
||
Country: Number of subjects enrolled |
Germany: 2
|
||
Country: Number of subjects enrolled |
Hungary: 2
|
||
Country: Number of subjects enrolled |
Italy: 2
|
||
Country: Number of subjects enrolled |
Latvia: 6
|
||
Country: Number of subjects enrolled |
France: 1
|
||
Country: Number of subjects enrolled |
Russian Federation: 35
|
||
Country: Number of subjects enrolled |
South Africa: 1
|
||
Country: Number of subjects enrolled |
Serbia: 4
|
||
Worldwide total number of subjects |
94
|
||
EEA total number of subjects |
54
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
21
|
||
Adolescents (12-17 years) |
73
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
|||||||||||||||||
|
Recruitment
|
|||||||||||||||||
Recruitment details |
The population enrolled in Study 12712B (78 weeks) were paediatric patients who had completed treatment in Study 12712A (26 weeks). Results are presented by duration of treatment relative to baseline in Study 12712A (104 weeks) and relative to baseline in Study 12712B (78 weeks). | ||||||||||||||||
|
Pre-assignment
|
|||||||||||||||||
Screening details |
Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study. | ||||||||||||||||
|
Period 1
|
|||||||||||||||||
Period 1 title |
Overall study (overall period)
|
||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
|
||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||
|
Arms
|
|||||||||||||||||
|
Arm title
|
Vortioxetine | ||||||||||||||||
Arm description |
- | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
vortioxetine
|
||||||||||||||||
Investigational medicinal product code |
Lu AA21004
|
||||||||||||||||
Other name |
|||||||||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||
Dosage and administration details |
5, 10, 15 or 20 mg/day oral tablets, 78 weeks of treatment
|
||||||||||||||||
|
|||||||||||||||||
|
|||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||
Reporting group title |
Overall study
|
||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Vortioxetine
|
||
Reporting group description |
- | ||
|
|||||||
End point title |
Number of Participants With Treatment-Emergent Adverse Events (Safety) [1] | ||||||
End point description |
Based on safety assessments (e.g. paediatric adverse event rating scale (PAERS), clinical safety laboratory tests (including reproductive hormones), vital signs, weight, height, Tanner score, menstrual cycle, ECG, and C-SSRS.
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
78 weeks
|
||||||
| 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: Only descriptive statistics |
|||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||||
End point title |
Change in Children Depression Rating Scale (CDRS-R) total score to Week 104 | ||||||||
End point description |
Children Depression Rating Scale, revised version. The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (depressed affect, listless speech, and hypoactivity). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. The total score ranges from 17 (normal) to 113 (severe depression).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712A baseline to Week 104
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||
End point title |
Number of relapses during the treatment period (78 weeks) | ||||||
End point description |
CDRS-R total score ≥40 with a history of 2 weeks of clinical deterioration
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
78 weeks
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Loss of remission during the treatment period (78 weeks) | ||||||
End point description |
CDRS-R total score <28 with a history of 2 weeks of clinical deterioration
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
78 weeks
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||||
End point title |
Change in Clinical Global Impression - Severity of Illness (CGI-S) score to Week 104 | ||||||||
End point description |
Clinical Global Impression - Severity of Illness. The CGI-S provides the clinician’s impression of the patient’s current state of mental illness.
The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal – not at all ill) to 7 (among the most extremely ill patients).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712A baseline to Week 104
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Clinical Global Impression-Improvement (CGI-I) score at Week 78 | ||||||||
End point description |
The Clinical Global Impression-Improvement (CGI-I) provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Week 78
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Children (7-11 years): change in BRIEF using the Global Executive Composite score to Week 104 | ||||||||
End point description |
Behaviour Rating Inventory of Executive Function. The BRIEF® is a patient- and carer-rated scale designed to measure executive function behaviour in children and adolescents in an everyday environment. We use BRIEF (parent form) for children aged 7 to 11 years. The BRIEF contains 86 items. Items are rated on a 3-point scale, from N (never) to O (often). These items cover 8 non-overlapping clinical scales: 3 scales in the Behavioural Regulation Index (inhibit, shift, and emotional control) and 5 scales in the Metacognition Index (initiate, working memory, plan/organize, organization of materials, and monitor). The clinical scales also provide the Global Executive Composite score, which represents the child’s overall executive function behaviour. There are 2 validity scales: negativity and inconsistency.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from 12712A baseline to Week 104
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Children (7-11 years): change in BRIEF using the Metacognition Index to Week 104 | ||||||||
End point description |
Behaviour Rating Inventory of Executive Function. The BRIEF® is a patient- and carer-rated scale designed to measure executive function behaviour in children and adolescents in an everyday environment. We use BRIEF (parent form) for children aged 7 to 11 years. The BRIEF contains 86 items. Items are rated on a 3-point scale, from N (never) to O (often). These items cover 8 non-overlapping clinical scales: 3 scales in the Behavioural Regulation Index (inhibit, shift, and emotional control) and 5 scales in the Metacognition Index (initiate, working memory, plan/organize, organization of materials, and monitor). The clinical scales also provide the Global Executive Composite score, which represents the child’s overall executive function behaviour. There are 2 validity scales: negativity and inconsistency.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712A baseline to Week 104
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score to Week 104 | ||||||||
End point description |
Behaviour Rating Inventory of Executive Function, Self-report version. Behaviour Rating Inventory of Executive Function. The BRIEF® is a patient- and carer-rated scale designed to measure executive function behaviour in children and adolescents in an everyday environment. We use BRIEF-SR (self-report) for the adolescents aged 11 to 17 years. The BRIEF contains 86 items. Items are rated on a 3-point scale, from N (never) to O (often). These items cover 8 non-overlapping clinical scales: 3 scales in the Behavioural Regulation Index (inhibit, shift, and emotional control) and 5 scales in the Metacognition Index (initiate, working memory, plan/organize, organization of materials, and monitor). The clinical scales also provide the Global Executive Composite score, which represents the child’s overall executive function behaviour. There are 2 validity scales: negativity and inconsistency.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712A baseline to Week 104
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Adolescents (12-17 years): change in BRIEF-SR using the Metacognition Index to Week 104 | ||||||||
End point description |
Behaviour Rating Inventory of Executive Function, Self-report version. Behaviour Rating Inventory of Executive Function. The BRIEF® is a patient- and carer-rated scale designed to measure executive function behaviour in children and adolescents in an everyday environment. We use BRIEF-SR (self-report) for the adolescents aged 11 to 17 years. The BRIEF contains 86 items. Items are rated on a 3-point scale, from N (never) to O (often). These items cover 8 non-overlapping clinical scales: 3 scales in the Behavioural Regulation Index (inhibit, shift, and emotional control) and 5 scales in the Metacognition Index (initiate, working memory, plan/organize, organization of materials, and monitor). The clinical scales also provide the Global Executive Composite score, which represents the child’s overall executive function behaviour. There are 2 validity scales: negativity and inconsistency.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712A baseline to Week 104
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) score to Week 104 | ||||||||
End point description |
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales. The PedsQL VAS is designed to measure at-that-moment functioning in children and
adolescents. The PedsQL™ VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue, and pain using visual analogue scales. The functionality for each domain is measured on a 10cm line with a happy face at one end and a sad face at the other. The patients are asked to mark on the line how they feel. The total score is the average of all 6 items, and the emotional distress summary score is the mean of the anxiety, sadness, anger, and worry items. A lower value represents a better outcome.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712A baseline to Week 104
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change in Children’s Global Assessment Scale (CGAS) score to Week 104 | ||||||||
End point description |
Children’s Global Assessment Scale. The CGAS is a clinician-rated global scale to measure the lowest level of functioning for a child (4 to 16 years) during a specified time period. The CGAS contains behaviourally oriented descriptors at each anchor point that depict behaviours and life situations applicable to a child. The score ranges from 1 (most functionally impaired child) to 100 (the healthiest). A score >70 indicates normal function.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712A baseline to Week 104
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change in Children Depression Rating Scale (CDRS-R) total score to Week 78 | ||||||||
End point description |
Children Depression Rating Scale, revised version. The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (depressed affect, listless speech, and hypoactivity). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. The total score ranges from 17 (normal) to 113 (severe depression).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712B baseline to Week 78
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||
End point title |
Number of relapses during the treatment period (78 weeks) | ||||||
End point description |
CDRS-R total score ≥40 with a history of 2 weeks of clinical deterioration
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
78 weeks
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Loss of remission during the treatment period up to (78 weeks) | ||||||
End point description |
CDRS-R total score <28 with a history of 2 weeks of clinical deterioration
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
78 weeks
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||||
End point title |
Change in Clinical Global Impression - Severity of Illness (CGI-S) score to Week 78 | ||||||||
End point description |
Clinical Global Impression - Severity of Illness. The CGI-S provides the clinician’s impression of the patient’s current state of mental illness.
The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal – not at all ill) to 7 (among the most extremely ill patients).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712B baseline to Week 78
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Children (7-11 years): change in BRIEF using the Global Executive Composite score to Week 78 | ||||||||
End point description |
Behaviour Rating Inventory of Executive Function. The BRIEF® is a patient- and carer-rated scale designed to measure executive function behaviour in children and adolescents in an everyday environment. We use BRIEF (parent form) for children aged 7 to 11 years. The BRIEF contains 86 items. Items are rated on a 3-point scale, from N (never) to O (often). These items cover 8 non-overlapping clinical scales: 3 scales in the Behavioural Regulation Index (inhibit, shift, and emotional control) and 5 scales in the Metacognition Index (initiate, working memory, plan/organize, organization of materials, and monitor). The clinical scales also provide the Global Executive Composite score, which represents the child’s overall executive function behaviour. There are 2 validity scales: negativity and inconsistency.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from 12712B baseline to Week 78
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Children (7-11 years): change in BRIEF using the Metacognition Index to Week 78 | ||||||||
End point description |
Behaviour Rating Inventory of Executive Function. The BRIEF® is a patient- and carer-rated scale designed to measure executive function behaviour in children and adolescents in an everyday environment. We use BRIEF (parent form) for children aged 7 to 11 years. The BRIEF contains 86 items. Items are rated on a 3-point scale, from N (never) to O (often). These items cover 8 non-overlapping clinical scales: 3 scales in the Behavioural Regulation Index (inhibit, shift, and emotional control) and 5 scales in the Metacognition Index (initiate, working memory, plan/organize, organization of materials, and monitor). The clinical scales also provide the Global Executive Composite score, which represents the child’s overall executive function behaviour. There are 2 validity scales: negativity and inconsistency.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712B baseline to Week 78
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score to Week 78 | ||||||||
End point description |
Behaviour Rating Inventory of Executive Function, Self-report version. Behaviour Rating Inventory of Executive Function. The BRIEF® is a patient- and carer-rated scale designed to measure executive function behaviour in children and adolescents in an everyday environment. We use BRIEF-SR (self-report) for the adolescents aged 11 to 17 years. The BRIEF contains 86 items. Items are rated on a 3-point scale, from N (never) to O (often). These items cover 8 non-overlapping clinical scales: 3 scales in the Behavioural Regulation Index (inhibit, shift, and emotional control) and 5 scales in the Metacognition Index (initiate, working memory, plan/organize, organization of materials, and monitor). The clinical scales also provide the Global Executive Composite score, which represents the child’s overall executive function behaviour. There are 2 validity scales: negativity and inconsistency.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712B baseline to Week 78
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Adolescents (12-17 years): change in BRIEF-SR using the Metacognition Index to Week 78 | ||||||||
End point description |
Behaviour Rating Inventory of Executive Function, Self-report version. Behaviour Rating Inventory of Executive Function. The BRIEF® is a patient- and carer-rated scale designed to measure executive function behaviour in children and adolescents in an everyday environment. We use BRIEF-SR (self-report) for the adolescents aged 11 to 17 years. The BRIEF contains 86 items. Items are rated on a 3-point scale, from N (never) to O (often). These items cover 8 non-overlapping clinical scales: 3 scales in the Behavioural Regulation Index (inhibit, shift, and emotional control) and 5 scales in the Metacognition Index (initiate, working memory, plan/organize, organization of materials, and monitor). The clinical scales also provide the Global Executive Composite score, which represents the child’s overall executive function behaviour. There are 2 validity scales: negativity and inconsistency.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712B baseline to Week 78
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) score to Week 78 | ||||||||
End point description |
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales. The PedsQL VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL™ VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue, and pain using visual analogue scales. The functionality for each domain is measured on a 10cm line with a happy face at one end and a sad face at the other. The patients are asked to mark on the line how they feel. The total score is the average of all 6 items, and the emotional distress summary score is the mean of the anxiety, sadness, anger, and worry items. A lower value represents a better outcome.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712B baseline to Week 78
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change in Children’s Global Assessment Scale (CGAS) score to Week 78 | ||||||||
End point description |
Children’s Global Assessment Scale. The CGAS is a clinician-rated global scale to measure the lowest level of functioning for a child (4 to 16 years) during a specified time period. The CGAS contains behaviourally oriented descriptors at each anchor point that depict behaviours and life situations applicable to a child. The score ranges from 1 (most functionally impaired child) to 100 (the healthiest). A score >70 indicates normal function.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from study 12712B baseline to Week 78
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Up to 82 weeks
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Vortioxetine 5, 10, 15 or 20 mg/day
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
