Clinical Trial Results:
A Multi-centre, Open-label, Long-term, Safety Trial of Clin RA Gel in the Treatment of Acne Vulgaris.
Summary
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EudraCT number |
2010-022912-37 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
21 Jan 2005
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jul 2016
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First version publication date |
29 Jul 2016
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Other versions |
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 |
MP-1501-01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medicis Pharmaceutical Corp.
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Sponsor organisation address |
8125 North Hayden Road, Scottsdale, United States, AZ 85258
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Public contact |
Group leader study manager, MEDA Pharma GmbH & Co KG, +49 6172 888 01, 42b@medapharma.de
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Scientific contact |
Head of Corporate Clinical Affairs, MEDA Pharma GmbH & Co KG, +49 6172 888 01, 42b@medapharma.de
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Sponsor organisation name |
Dow Pharmaceutical Sciences, Inc.
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Sponsor organisation address |
1330A Redwood Way, Petaluma, United States, CA 94954- 1169
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Public contact |
Group leader study manager, MEDA Pharma GmbH & Co KG, +49 6172 888 01, 42b@medapharma.de
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Scientific contact |
Head of Corporate Clinical Affairs, MEDA Pharma GmbH & Co KG, +49 6172 888 01, 42b@medapharma.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000892-PIP01-10 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Apr 2006
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Jan 2005
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Jan 2005
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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 |
The primary objective of the study is to assess the long-term safety of the new combination therapy as a single therapy or with other concomitant acne medications for a six month period or one year period.
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Protection of trial subjects |
No specific additional measures to minimise pain and distress were required. The subjects could withdraw from treatment at any time and for any reason.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Jan 2004
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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 |
United States: 442
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Worldwide total number of subjects |
442
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
242
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Adults (18-64 years) |
200
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Male or female subjects of any race, 12 years of age or older, with mild, moderate, or severe acne vulgaris. | |||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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Cohort 1 | |||||||||||||||||||||||||||||||||
Arm description |
Cohort 1 consists of all subjects who entered the long-term study and are the population of subjects in the 0 to 6 Month analyses. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Clin RA Gel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Topical use
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Dosage and administration details |
Topical application of study drug (active ingredients: Clindamycin phosphate 1.2% and Tretinoin 0.025% ) was made to the face once daily prior to bedtime, as directed by the investigator. After cleansing, the study drug was applied as a thin coating and rubbed into the skin. Total weekly dosage of study drug was anticipated to be no more than approximately 5 g/week.
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Arm title
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Cohort 2 | |||||||||||||||||||||||||||||||||
Arm description |
Cohort 2 consists of those subjects in Cohort 1 who continued to participate in the study past their 6-month visit and are the population of subjects in the 7 to 12-month analyses. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Clin RA Gel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Topical use
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Dosage and administration details |
Topical application of study drug (active ingredients: Clindamycin phosphate 1.2% and Tretinoin 0.025% ) was made to the face once daily prior to bedtime, as directed by the investigator. After cleansing, the study drug was applied as a thin coating and rubbed into the skin. Total weekly dosage of study drug was anticipated to be no more than approximately 5 g/week.
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Baseline characteristics reporting groups
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Reporting group title |
Cohort 1
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Reporting group description |
Cohort 1 consists of all subjects who entered the long-term study and are the population of subjects in the 0 to 6 Month analyses. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 2
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Reporting group description |
Cohort 2 consists of those subjects in Cohort 1 who continued to participate in the study past their 6-month visit and are the population of subjects in the 7 to 12-month analyses. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cohort 1
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Reporting group description |
Cohort 1 consists of all subjects who entered the long-term study and are the population of subjects in the 0 to 6 Month analyses. | ||
Reporting group title |
Cohort 2
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Reporting group description |
Cohort 2 consists of those subjects in Cohort 1 who continued to participate in the study past their 6-month visit and are the population of subjects in the 7 to 12-month analyses. |
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End point title |
Evaluator's Global Severity Score at Month 1 [1] [2] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 1 after 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: No other statistical analyses besides descriptive statistics available for this end point. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 1. |
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Notes [3] - 424 subjects available at month 1. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 2 [4] [5] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 2 after baseline.
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No other statistical analyses besides descriptive statistics available for this end point. [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 1. |
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Notes [6] - 395 subjects avalibale at month 2. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 3 [7] [8] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 3 after baseline.
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Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No other statistical analyses besides descriptive statistics available for this end point. [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 1. |
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Notes [9] - 384 subjects avaliable at month 3. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 4 [10] [11] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 4 after baseline.
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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: No other statistical analyses besides descriptive statistics available for this end point. [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 1. |
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Notes [12] - 367 subjects available at month 4. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 5 [13] [14] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 5 after baseline.
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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: No other statistical analyses besides descriptive statistics available for this end point. [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 1. |
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Notes [15] - 354 subjects available at month 5. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 6 [16] [17] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 6 after baseline.
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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: No other statistical analyses besides descriptive statistics available for this end point. [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 1. |
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Notes [18] - 351 subjects available at month 6. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 7 [19] [20] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 7 after baseline.
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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: No other statistical analyses besides descriptive statistics available for this end point. [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 2. |
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Notes [21] - 206 subjects available at month 7. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 8 [22] [23] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 8 after baseline.
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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: No other statistical analyses besides descriptive statistics available for this end point. [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 2. |
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Notes [24] - 200 subjects available at month 8. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 9 [25] [26] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 9 after baseline.
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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: No other statistical analyses besides descriptive statistics available for this end point. [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 2. |
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Notes [27] - 201 subjects available at month 9. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 10 [28] [29] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 10 after baseline.
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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: No other statistical analyses besides descriptive statistics available for this end point. [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 2. |
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Notes [30] - 198 subjects available at month 10. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 11 [31] [32] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 11 after baseline.
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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: No other statistical analyses besides descriptive statistics available for this end point. [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 2. |
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Notes [33] - 196 subjects available at month 11. |
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No statistical analyses for this end point |
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End point title |
Evaluator's Global Severity Score at Month 12 [34] [35] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Month 12 after baseline.
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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: No other statistical analyses besides descriptive statistics available for this end point. [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point reports only statistics for the arm Cohort 2. |
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Notes [36] - 195 subjects available at month 12. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Study duration.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
7.0
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Reporting groups
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Reporting group title |
Safety Evaluable Population
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 0.5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |