Clinical Trial Results:
A Phase 3 Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia
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Summary
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EudraCT number |
2021-004467-26 |
Trial protocol |
FR |
Global end of trial date |
15 Dec 2025
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jul 2026
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First version publication date |
01 Jul 2026
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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 |
DIUR-015
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05299554 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
IND Number: 76485 | ||
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Sponsors
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Sponsor organisation name |
Immedica Pharma AB
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Sponsor organisation address |
Solnavägen 3H, Stockholm, Sweden, 113 63
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Public contact |
Global Integrated Evidence Generation, Immedica Pharma AB, clinical@immedica.com
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Scientific contact |
Global Integrated Evidence Generation, Immedica Pharma AB, clinical@immedica.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Feb 2026
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Dec 2025
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Dec 2025
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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 long-term safety and tolerability of Chronocort in the treatment of participants with Congenital Adrenal Hyperplasia (CAH).
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Protection of trial subjects |
The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, with ICH Good Clinical Practice (GCP) requirements, and with the USA Code of Federal Regulations (CFR) on Protection of Human Rights (21 CFR 50) (USA only). The principles of informed consent in the Declaration of Helsinki, in the current requirements of GCP and local regulation, whichever afforded the greater participant protection, were implemented before any procedures or interventions were carried out. A signed and dated informed consent form (ICF) was obtained from each adult participant prior to entering the study. Minors were assented and parental consent sought in keeping with local laws and local IEC/IRB requirements. Minors were re-consented on reaching the age of majority if still participating at that time. The Investigator was responsible for obtaining written informed consent after adequate explanation of the aims, methods, anticipated benefits, and potential hazards of the study and before any protocol-specified screening procedures or any study medications were administered. Information was given in both oral and written form whenever possible, and as deemed appropriate by the IECs/IRBs. Participants were also asked for consent to allow the Sponsor, Sponsor representative or external regulatory auditor to review their medical records to confirm GCP compliance. All ICFs were provided in local language. Acquisition of informed consent was documented in the participant's medical record and the ICF was signed and dated by the participant or their legally acceptable representative, as well as by the person who conducted the discussion. The original signed ICF was retained with the medical records at site, with a copy in the Site File and a further copy provided to the participant prior to the start of the study interventions. Representative written information for the participant and a sample ICF were filed in the Trial Master File.
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Background therapy |
Fludrocortisone dose adjustments were made if medically indicated and were based on blood pressure measurements and laboratory data. | ||
Evidence for comparator |
Since all participants who took part in this study received Chronocort, there were no formal treatment comparisons. Summaries over time were produced for safety and efficacy parameters | ||
Actual start date of recruitment |
01 Apr 2022
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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 |
France: 42
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Country: Number of subjects enrolled |
Japan: 8
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Country: Number of subjects enrolled |
United States: 26
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Worldwide total number of subjects |
76
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EEA total number of subjects |
42
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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) |
4
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Adults (18-64 years) |
71
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
All eligible participants from France, USA and Japan who completed Study DIUR-006 (up to 30 participants) or DIUR-014 (up to 46 participants) could have entered this study, giving a maximum of 76 participants. The study centres in this study were the same centres that recruited the participants into the feeder studies. | ||||||||||||
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Pre-assignment
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Screening details |
Participants attended a screening visit prior to baseline assessments to allow DIUR-015 to be fully explained and to give informed consent/assent. Participants who had a gap between completing the feeder study and starting DIUR-015 had safety blood tests as part of screening. | ||||||||||||
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Period 1
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Period 1 title |
Overall Treatment Period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Blinding implementation details |
Blinding was not applicable to this open-label extension study where all participants received Chronocort
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Arms
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Arm title
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Chronocort | ||||||||||||
Arm description |
Open-label treatment with Chronocort | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Chronocort
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Investigational medicinal product code |
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Other name |
Efmody
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Pharmaceutical forms |
Modified-release capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Participants from DIUR-006 continued on the same total daily dose of Chronocort received in the feeder study, unless the Investigator thought a dose titration was needed, in which case details of the titration were recorded in the eCRF. As study DIUR-014 was blinded, the treatment and dose were not known to the Investigator so each participant’s total hydrocortisone daily dose recorded in the IRT from DIUR-014 was provided to the Investigator. Participants then received their initial dose of Chronocort in DIUR-015 matched to this 1:1. To ensure all participants entering from DIUR-014 were receiving the correct dose, they had a titration visit at Week 6, with an optional 2nd dose titration at Week 12 of DIUR 015. All participants were instructed to take Chronocort 2 times daily: on waking and just prior to bed. The daily Chronocort dose was split approximately ⅓-¼ in the morning and ⅔-¾ in the evening (exceptions to this dosing split could be made by the Investigator if warranted).
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Baseline characteristics reporting groups
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Reporting group title |
Overall Treatment Period
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Reporting group description |
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End points reporting groups
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Reporting group title |
Chronocort
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Reporting group description |
Open-label treatment with Chronocort | ||
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End point title |
Safety and Tolerability: Signs and symptoms of adrenal insufficiency or over-treatment – Baseline [1] | ||||||||||
End point description |
Adrenal insufficiency checklist results as reported at DIUR-015 study visits
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End point type |
Primary
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End point timeframe |
DIUR-015 Baseline
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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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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End point title |
Safety and Tolerability: Signs and symptoms of adrenal insufficiency or over-treatment – Week 6 [2] | ||||||||||
End point description |
Adrenal insufficiency checklist results as reported at DIUR-015 study visits
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End point type |
Primary
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End point timeframe |
DIUR-015 Week 6
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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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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End point title |
Safety and Tolerability: Signs and symptoms of adrenal insufficiency or over-treatment – Week 12 [3] | ||||||||||
End point description |
Adrenal insufficiency checklist results as reported at DIUR-015 study visits
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End point type |
Primary
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End point timeframe |
DIUR-015 week 12
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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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Safety and Tolerability: Signs and symptoms of adrenal insufficiency or over-treatment – week 24 [4] | ||||||||||
End point description |
Adrenal insufficiency checklist results as reported at DIUR-015 study visits
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End point type |
Primary
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End point timeframe |
DIUR-015 Week 24
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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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Safety and Tolerability: Signs and symptoms of adrenal insufficiency or over-treatment – 1 Year [5] | ||||||||||
End point description |
Adrenal insufficiency checklist results as reported at DIUR-015 study visits
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End point type |
Primary
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End point timeframe |
DIUR-015 1 year
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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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Safety and Tolerability: Signs and symptoms of adrenal insufficiency or over-treatment – 2 years [6] | ||||||||||
End point description |
Adrenal insufficiency checklist results as reported at DIUR-015 study visits
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End point type |
Primary
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End point timeframe |
DIUR-015 2 year visit
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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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Safety and Tolerability: Signs and symptoms of adrenal insufficiency or over-treatment – 2.5 Years [7] | ||||||||||
End point description |
Adrenal insufficiency checklist results as reported at DIUR-015 study visits
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End point type |
Primary
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End point timeframe |
DIUR-015 2.5 Year visit
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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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Safety and Tolerability: Signs and symptoms of adrenal insufficiency or over-treatment – 3 Years [8] | ||||||||||
End point description |
Adrenal insufficiency checklist results as reported at DIUR-015 study visits
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End point type |
Primary
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End point timeframe |
DIUR-015 3 Year visit
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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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Safety and Tolerability: Use of Sick Day Medications [9] | ||||||||||
End point description |
Safety and tolerability of Chronocort as assessed by number of participants using of sick day medications throughout the study.
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End point type |
Primary
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End point timeframe |
3 Years (assessed at each DIUR-015 visit)
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| Notes [9] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Safety and Tolerability: Occurence of adrenal crises throughout the study [10] | ||||||
End point description |
Participants experiencing adrenal crisis during the study
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End point type |
Primary
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End point timeframe |
3 Years (assessed at each study visit)
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| Notes [10] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||
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End point title |
Safety and Tolerability: Participants experiencing adverse events throughout the study [11] | ||||||||||||||||||||||||||||||||||
End point description |
Summary of participants experiencing adverse events throughout the study
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End point type |
Primary
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End point timeframe |
3 Years (assessed at each study visit)
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| Notes [11] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||
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End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline - Eosinophils [12] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category.
No formal statistical comparisons were performed; analyses are descriptive in nature.
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End point type |
Primary
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End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
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| Notes [12] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline - Eosinophils [13] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
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End point type |
Primary
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End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
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| Notes [13] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline - Haemoglobin [14] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
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End point type |
Primary
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End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
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| Notes [14] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline - Haemoglobin [15] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
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End point type |
Primary
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End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
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| Notes [15] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline - Basophils [16] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
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End point type |
Primary
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End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
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| Notes [16] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline - Basophils [17] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
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End point type |
Primary
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End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
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| Notes [17] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Basophils/Leukocytes (%) [18] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [18] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline - Basophils/Leukocytes (%) [19] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [19] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Eosinophils/Leukocytes (%) [20] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [20] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline - Eosinophils/Leukocytes (%) [21] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [21] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – MCHC (g/l) [22] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [22] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline - MCHC (g/l) [23] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [23] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – MCH (pg) [24] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [24] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – MCH (pg) [25] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [25] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – MCV (fL) [26] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [26] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – MCV (fL) [27] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [27] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Erythrocytes (10^12/L) [28] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [28] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Erythrocytes (10^12/L) [29] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [29] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – RDW [30] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [30] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – RDW [31] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [31] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Haematocrit [32] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [32] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Haematocrit [33] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [33] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Leukocytes [34] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [34] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Leukocytes [35] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [35] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Lymphocytes [36] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [36] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Lymphocytes [37] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [37] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Lymphocytes/Leukocytes [38] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [38] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Lymphocytes/Leukocytes [39] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [39] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Monocytes [40] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [40] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Monocytes [41] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [41] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Monocytes/Leukocytes [42] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [42] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Monocytes/Leukocytes [43] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [43] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Neutrophils [44] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [44] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Neutrophils [45] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [45] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Neutrophils/Leukocytes [46] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [46] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Neutrophils/Leukocytes [47] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [47] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Platelets [48] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [48] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Platelets [49] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [49] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Alanine Aminotransferase [50] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [50] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Alanine Aminotransferase [51] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [51] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Albumin [52] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [52] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Albumin [53] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [53] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Alkaline Phosphatase [54] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [54] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Alkaline Phosphatase [55] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [55] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Aspartate Aminotransferase [56] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [56] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Aspartate Aminotransferase [57] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [57] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Bicarbonate [58] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [58] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Bicarbonate [59] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [59] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Bilirubin [60] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [60] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Bilirubin [61] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [61] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Calcium [62] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [62] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Calcium [63] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [63] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Chloride [64] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [64] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Chloride [65] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [65] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Creatine Kinase [66] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [66] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Creatine Kinase [67] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [67] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Creatinine Enzymatic [68] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [68] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Creatinine Enzymatic [69] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [69] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Direct Bilirubin [70] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [70] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Direct Bilirubin [71] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [71] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Lactate Dehydrogenase [72] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [72] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Lactate Dehydrogenase [73] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [73] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Magnesium [74] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [74] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Magnesium [75] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [75] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Phosphate [76] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [76] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Phosphate [77] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [77] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Potassium [78] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [78] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Potassium [79] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [79] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Protein [80] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [80] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Protein [81] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [81] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Sodium [82] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [82] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Sodium [83] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [83] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Urate [84] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [84] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Urate [85] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [85] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Urea Nitrogen [86] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [86] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Urea Nitrogen [87] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of laboratory parameter values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined laboratory reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [87] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Diastolic Blood Pressure [88] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of vital signs values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [88] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Diastolic Blood Pressure [89] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of vital signs values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [89] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at minimum on-treatment versus pre-Chronocort baseline – Systolic Blood Pressure [90] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of vital signs values at the minimum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined reference ranges. For each participant, the minimum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [90] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Safety and Tolerability: Categorical distribution of values at maximum on-treatment versus pre-Chronocort baseline – Systolic Blood Pressure [91] | ||||||||||||||||||||||||
End point description |
This endpoint summarises the categorical distribution of vital signs values at the maximum on-treatment timepoint compared with pre-Chronocort baseline. Values were categorised as low, normal, or high according to predefined reference ranges. For each participant, the maximum value observed during the on-treatment period was identified and categorised accordingly. Results are presented as the number of participants in each category, stratified by their corresponding pre-Chronocort baseline category. No formal statistical comparisons were performed; analyses are descriptive in nature.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Throughout DIUR-015 treatment period of up to 3 years
|
||||||||||||||||||||||||
| Notes [91] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||
End point title |
Safety and Tolerability: Signs and symptoms of adrenal insufficiency or over-treatment – 1.5 years [92] | ||||||||||
End point description |
Adrenal insufficiency checklist results as reported at DIUR-015 study visits
|
||||||||||
End point type |
Primary
|
||||||||||
End point timeframe |
DIUR-015 1.5 year visit
|
||||||||||
| Notes [92] - 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: The full analysis set was used for all data summaries. Summaries over time were produced for safety and efficacy parameters. |
|||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at Week 24 | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, Week 24
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 1 Year | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 1-year
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 1.5 years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 1.5 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 2 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 2 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 2.5 years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 2.5 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 3 years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 3 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 4 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 4 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 4.5 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 4.5 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 5 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 5 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 5.5 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 5.5 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 6 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 6 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 6.5 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 6.5 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 7 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 7 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean total daily steroid dose at 7.5 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous
Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 7.5 Years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in 17-OHP Levels at Week 24 | ||||||||
End point description |
Change from pre-Chronocort baseline in mean 17-Hydroxyprogesterone (17-OHP) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, Week 24
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in 17-OHP Levels at 1 Year | ||||||||
End point description |
Change from pre-Chronocort baseline in mean 17-Hydroxyprogesterone (17-OHP) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 1 year
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in 17-OHP Levels at 2 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean 17-Hydroxyprogesterone (17-OHP) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 2 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in 17-OHP Levels at 3 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean 17-Hydroxyprogesterone (17-OHP) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 3 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in 17-OHP Levels at 4 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean 17-Hydroxyprogesterone (17-OHP) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 4 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in 17-OHP Levels at 5 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean 17-Hydroxyprogesterone (17-OHP) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 5 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in 17-OHP Levels at 6 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean 17-Hydroxyprogesterone (17-OHP) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 6 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in 17-OHP Levels at 7 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean 17-Hydroxyprogesterone (17-OHP) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 7 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in 17-OHP Levels at 8 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean 17-Hydroxyprogesterone (17-OHP) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 8 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in A4 Levels at Week 24 | ||||||||
End point description |
Change from pre-Chronocort baseline in mean androstenedione (A4) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, Week 24
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in A4 Levels at 1 Year | ||||||||
End point description |
Change from pre-Chronocort baseline in mean androstenedione (A4) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 1 year
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in A4 Levels at 2 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean androstenedione (A4) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 2 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in A4 Levels at 3 years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean androstenedione (A4) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 3 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in A4 Levels at 4 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean androstenedione (A4) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 4 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in A4 Levels at 5 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean androstenedione (A4) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 5 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in A4 Levels at 6 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean androstenedione (A4) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 6 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in A4 Levels at 7 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean androstenedione (A4) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 7 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in A4 Levels at 8 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean androstenedione (A4) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 8 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||
End point title |
Menstrual regularity in pre-menopausal females without hysterectomy and not using hormonal contraceptives at pre-Chronocort baseline | ||||||||||||||||
End point description |
Data are presented for participants with more than monthly menstrual cycles, monthly menstrual cycles, number of participants with oligomenorrhoea, amenorrhoea or not determinable. Oligomenorrhoea was defined as cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Pre-Chronocort Baseline
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Menstrual regularity in pre-menopausal females without hysterectomy and not using hormonal contraceptives at Week 24 | ||||||||||||||||
End point description |
Data are presented for participants with more than monthly menstrual cycles, monthly menstrual cycles, number of participants with oligomenorrhoea, amenorrhoea or not determinable. Oligomenorrhoea was defined as cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Menstrual regularity in pre-menopausal females without hysterectomy and not using hormonal contraceptives at 1 Year | ||||||||||||||||
End point description |
Data are presented for participants with more than monthly menstrual cycles, monthly menstrual cycles, number of participants with oligomenorrhoea, amenorrhoea or not determinable. Oligomenorrhoea was defined as cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
1 Year
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Menstrual regularity in pre-menopausal females without hysterectomy and not using hormonal contraceptives at 2 Year | ||||||||||||||||
End point description |
Data are presented for participants with more than monthly menstrual cycles, monthly menstrual cycles, number of participants with oligomenorrhoea, amenorrhoea or not determinable. Oligomenorrhoea was defined as cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
2 Years
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Menstrual regularity in pre-menopausal females without hysterectomy and not using hormonal contraceptives at 3 Years | ||||||||||||||||
End point description |
Data are presented for participants with more than monthly menstrual cycles, monthly menstrual cycles, number of participants with oligomenorrhoea, amenorrhoea or not determinable. Oligomenorrhoea was defined as cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
3 Years
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Menstrual regularity in pre-menopausal females without hysterectomy and not using hormonal contraceptives at 4 Years | ||||||||||||||||
End point description |
Data are presented for participants with more than monthly menstrual cycles, monthly menstrual cycles, number of participants with oligomenorrhoea, amenorrhoea or not determinable. Oligomenorrhoea was defined as cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
4 years
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Menstrual regularity in pre-menopausal females without hysterectomy and not using hormonal contraceptives at 5 Years | ||||||||||||||||
End point description |
Data are presented for participants with more than monthly menstrual cycles, monthly menstrual cycles, number of participants with oligomenorrhoea, amenorrhoea or not determinable. Oligomenorrhoea was defined as cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
5 Years
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Menstrual regularity in pre-menopausal females without hysterectomy and not using hormonal contraceptives at 6 Years | ||||||||||||||||
End point description |
Data are presented for participants with more than monthly menstrual cycles, monthly menstrual cycles, number of participants with oligomenorrhoea, amenorrhoea or not determinable. Oligomenorrhoea was defined as cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
6 years
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Menstrual regularity in pre-menopausal females without hysterectomy and not using hormonal contraceptives at 7 Years | ||||||||||||||||
End point description |
Data are presented for participants with more than monthly menstrual cycles, monthly menstrual cycles, number of participants with oligomenorrhoea, amenorrhoea or not determinable. Oligomenorrhoea was defined as cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
7 Years
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Menstrual regularity in pre-menopausal females without hysterectomy and not using hormonal contraceptives at 8 Years | ||||||||||||||||
End point description |
Data are presented for participants with more than monthly menstrual cycles, monthly menstrual cycles, number of participants with oligomenorrhoea, amenorrhoea or not determinable. Oligomenorrhoea was defined as cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
8 years
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean LH Levels for males only at 24 Weeks | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Luteinizing Hormone (LH) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 24 Weeks
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean LH Levels for males only at 1 Year | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Luteinizing Hormone (LH) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 1 year
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean LH Levels for males only at 2 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Luteinizing Hormone (LH) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 2 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean LH Levels for males only at 3 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Luteinizing Hormone (LH) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 3 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean LH Levels for males only at 4 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Luteinizing Hormone (LH) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 4 years
|
||||||||
|
|||||||||
| Notes [93] - No data is available from 4 years onwards |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Females at Week 24 | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, week 24
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Females at 1 Year | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 1 year
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Females at 2 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 2 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Females at 3 years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 3 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Females at 4 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 4 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Females at 5 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 5 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Females at 6 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 6 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Females at 7 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 7 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Females at 8 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 8 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Males at week 24 | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, week 24
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Males at 1 Year | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 1 year
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Males at 2 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 2 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Males at 3 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 3 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Males at 4 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 4 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Males at 5 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 5 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Males at 6 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 6 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Males at 7 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 7 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Pre-Chronocort Baseline in mean T Levels in Males at 8 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean Testosterone (T) levels. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 8 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean waist circumference at Week 24 | ||||||||
End point description |
Change from pre-Chronocort baseline in mean waist circumference. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, week 24
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean waist circumference at 1 Year | ||||||||
End point description |
Change from pre-Chronocort baseline in mean waist circumference. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 1 year
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean waist circumference at 2 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean waist circumference. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 2 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean waist circumference at 3 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean waist circumference. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 3 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean waist circumference at 4 years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean waist circumference. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 4 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean waist circumference at 5 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean waist circumference. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 5 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean waist circumference at 6 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean waist circumference. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 6 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean waist circumference at 7 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean waist circumference. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 7 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean waist circumference at 8 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean waist circumference. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 8 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean body weight at week 24 | ||||||||
End point description |
Change from pre-Chronocort baseline in mean body weight. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 24 weeks
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean body weight at 1 Year | ||||||||
End point description |
Change from pre-Chronocort baseline in mean body weight. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 1 year
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean body weight at 2 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean body weight. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 2 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean body weight at 3 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean body weight. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 3 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean body weight at 4 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean body weight. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 4 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean body weight at 5 years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean body weight. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 5 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean body weight at 6 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean body weight. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 6 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean body weight at 7 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean body weight. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 7 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from pre-Chronocort baseline in mean body weight at 8 Years | ||||||||
End point description |
Change from pre-Chronocort baseline in mean body weight. Pre-Chronocort baseline is defined as the last non-missing value prior to the first dose of continuous Chronocort received by the participant, from either the feeder study or from DIUR-015. Analysis visits were assigned using windowing, by calculating time relative to the pre-Chronocort baseline.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-Chronocort Baseline, 8 years
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Up to 30 days after last study dose (maximum treatment duration of approximately 3 years)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
28.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Chronocort
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Open-label treatment with Chronocort | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
15 Sep 2021 |
1) Titration visit at Week 4 for participants entering from study DIUR-014 moved to Week 6 and second titration visit at Week 12 made optional to reduce the number of times participants have to attend clinic visits.
2) Alertness visual analogue scale removed from the efficacy assessments and the study objectives and endpoints since this was no longer considered necessary.
3) Added at the request of some Investigators that participants who became pregnant could remain in the study but discontinue study treatment and can restart study treatment 6 weeks post pregnancy/post-lactation.
4) Electronic diary changed to a paper diary.
|
||
17 Jan 2022 |
1) Information on drug interactions and dose modifications added from the Summary of Product Characteristics (SmPC) at the request of the French Regulatory Authority.
2) Information on remote monitoring visits added at the request of the French Regulatory Authority.
|
||
26 Jan 2022 |
Exclusion criterion added to exclude participants with a body weight of 50 kg or less in France. |
||
23 Feb 2022 |
1) Clarified that baseline androgen results for participants entering from study DIUR 014 would not be available to the Investigator and local androgen testing must not be conducted in order to maintain the blinding of the DIUR-014 study.
2) BMI added to the assessments.
3) Assessment of demographic details moved from the baseline visit to the screening visit since this assessment is needed to check eligibility into the study.
4) Measurement plasma renin removed since no longer required.
5) Concomitant therapy requirements clarified.
6) Additional details added on the assessments required for domiciliary and off-site clinic/laboratory visits.
7) Pharmacovigilance provider changed.
8) Urinalysis removed from the required laboratory assessments (but noted that this can be performed locally if indicated).
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05 Apr 2022 |
1) Bulgaria removed since it was no longer included in the DIUR-014 feeder study.
2) Added that screening and baseline visits can be combined for participants who entered this extension study from their feeder study without a gap to reduce the number of visits required for participants that rolled straight into the study from their feeder study.
3) Clarified that informed consent was to be obtained up to 14 days before, or at the baseline visit for this DIUR-015 study.
4) Clarified that AESIs were to be reported using the SAE form, which was renamed the SAE/AESI form. Events causing implementation of ‘stress dosing rules’ were also removed from the list of AESIs since these are captured elsewhere.
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13 Apr 2023 |
1) Removed the requirement for informed consent to be taken within 14 days of the baseline visit and clarified informed consent needed before any screening or baseline procedures.
2) Added that the exploratory plasma/serum research samples are optional.
3) Turkey removed since it was no longer included in the DIUR-014 feeder study.
4) Added that the total amount of blood collected would not exceed each site's policy, and that the amount of blood collected at each visit would not exceed 40 mL.
5) Added that participants would continue in the study until December 2024, when a decision would be made to either switch the participant onto Chronocort commercial supply, extend the study, or return the participant to standard of care therapy.
6) Details of the transfer of the participant’s total daily dose details from the DIUR 014 IRT clarified.
7) Added that dose changes should be made in 5 mg increments.
8) Added that the baseline testosterone sample can be taken from the last visit of the feeder study.
9) Window around the annual visits has been increased to 4 weeks to allow flexibility of scheduling the annual visits.
10) Added that participants from study DIUR-014 were instructed to take a 10 mg hydrocortisone dose from their emergency treatment pack between 15:00 and 17:00 on Day 1 to avoid under replacement of cortisol and unblinding the DIUR 014 study.
11) Table of blood volumes at each visit added.
12) Changed to specify that the EQ-5D-5L QoL questionnaire should be completed on paper not through the participant diary.
13) Follow-up on pregnancies in female partners of male participants changed from 6-8 weeks to 30 days.
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31 Jul 2024 |
(US-specific amendment)
1) Trial extended until December 2025 in USA only to collect long-term data in USA participants.
2) The definition of pre-Chronocort baseline revised to specify the screening visit (Visit 1) for DIUR-014 so that the pre-Chronocort baseline is captured before the run-in medication is given in study DIUR-014.
3) Added that there may be exceptions to the recommended dosing split of approximately ⅓ to ¼ of the total daily dose in the morning on waking and ⅔ to ¾ of the total daily dose at night just prior to bed to allow flexibility if a participant did not tolerate the higher dose at night.
4) Added that assessment of menstrual changes was needed in pre-menopausal females without hysterectomy and that these are required on a weekly basis.
5) Clarified that only participants who had a dose change were required to have a follow up phone call 1 week later.
6) Statement added about increased fertility with Chronocort which could lead to unexpected pregnancies to align with the SmPC.
7) 5 mg oral hydrocortisone tablets added to allow provision of 5 mg or 10 mg oral hydrocortisone tablets.
8) Definition of Addisonian crisis updated to bring it in line with the definition used in other studies.
9) Clarified that not all clinically significant laboratory changes had to be recorded as an AE – only if they were considered an AE by the investigator.
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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 | |||
