Clinical Trial Results:
A RANDOMIZED CONTROLLED STUDY ON THE EFFECTIVENESS OF FIRST-LINE CHEMOTHERAPY (CARBOPLATIN AND PACLITAXEL) VERSUS CHEMO-IMMUNOTHERAPY (CARBOPLATIN-PACLITAXEL-OREGOVOMAB) IN PATIENTS WITH ADVANCED EPITHELIAL OVARIAN, ADNEXAL OR PERITONEAL CARCINOMA
Summary
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EudraCT number |
2010-024305-13 |
Trial protocol |
IT |
Global end of trial date |
12 Oct 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Oct 2021
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First version publication date |
16 Oct 2021
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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 |
QPT-ORE-02
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01616303 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
OncoQuest Pharmaceuticals Inc.
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Sponsor organisation address |
670-21 Sannae-ro, Sannae-myeon Miryang-Si, Korea, Republic of,
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Public contact |
Thomas Woo, VP of Product Development, OncoQuest Pharmaceuticals Inc., 1 780 448 1400, thomas@oncoquestinc.com
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Scientific contact |
Thomas Woo, VP of Product Development, OncoQuest Pharmaceuticals Inc., 1 780 448 1400, thomas@oncoquestinc.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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Feb 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Jun 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Oct 2018
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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 |
Confirm and clarify the preliminary results of Braly8 on the induction of CA125-specific cellular immunity of clinical relevance with Oregovomab infusion associated with first-line chemotherapy in patients with stage III-IV ovarian cancer. The primary objective of the clinical trial is the evaluation of anti CA125 cellular immune response by ELISPOT assay.
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Protection of trial subjects |
Each enrolled patient was carefully monitored for any potential adverse events from the study treatment. If any adverse events were happened, patients were treated accordingly. Insurance was also provided.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Dec 2011
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
3 Years | ||
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 |
Italy: 81
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Country: Number of subjects enrolled |
United States: 16
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Worldwide total number of subjects |
97
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EEA total number of subjects |
81
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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) |
0
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Adults (18-64 years) |
72
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From 65 to 84 years |
25
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 137 patients were screened, and 40 failed screening. A total of 97 patients were randomly assigned to treatment, and 94 were treated; 91 patients entered follow-up. Eight patients (17.0%) in Arm 1 and 12 patients (24.0%) in Arm 2 discontinued from the study. | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Patients were screened for eligibility up to 4 weeks before treatment. Informed consent was obtained before any protocol-specific screening evaluations were done. Once all eligibility criteria were met, the patient was randomly assigned to a treatment arm. The treatment period began immediately after randomization. | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment Period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Arm 1 | ||||||||||||||||||||||||||||||
Arm description |
Treatment Arm 1 (40 patients planned) received, sequentially on the same day, carboplatin area under the curve (AUC) 6 administered intravenously (IV) every 3 weeks (21 days) for 6 cycles, paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles, and oregovomab 2 mg infused IV over 20 minutes administered during the first, third, and fifth cycles. Patients in Arm 1 also received oregovomab as monotherapy 12 weeks after the fifth cycle. At the discretion of the investigator, treatment with oregovomab may have been discontinued for patients who experienced an allergic event. No other oregovomab dosage modification was permitted without prior approval from the medical monitor. Oregovomab, when dosed at 2 mg, has been demonstrated to induce cross-presentation of CA125 peptide fragments and induce a CA125-specific cellular immune response and has been well tolerated in clinical trials. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Oregovomab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Oregovomab was supplied in vials containing 2 mg of the monoclonal antibody with a reducing
agent, a buffer complex, and excipients.
The lyophilized contents of the vial of oregovomab were dissolved in 2 mL of 0.9% sodium
chloride injection US Pharmacopeia then added to 50 mL of 0.9% sodium chloride injection USP
in a small (50 mL) infusion bag.
Paclitaxel was diluted before infusion in 0.9% sodium chloride injection, 5% dextrose injection,
5% dextrose and 0.9% sodium chloride injection, or 5% dextrose in Ringer's injection to a final
concentration of 0.3 to 1.2 mg/mL.
Carboplatin powder was reconstituted for injection with sterile water for injection, dextrose 5%
in water, or sodium chloride 0.9 concentration of 10 mg/mL. Reconstituted solution, or premixed aqueous solution, may have
been further diluted with dextrose 5% in water or sodium chloride 0.9% injection.
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Investigational medicinal product name |
carboplatin + paclitaxel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Paclitaxel was diluted before infusion in 0.9% sodium chloride injection, 5% dextrose injection,
5% dextrose and 0.9% sodium chloride injection, or 5% dextrose in Ringer's injection to a final
concentration of 0.3 to 1.2 mg/mL.
Carboplatin powder was reconstituted for injection with sterile water for injection, dextrose 5%
in water, or sodium chloride 0.9% injection. Diluent was added to produce a solution with a final concentration of 10 mg/mL. Reconstituted solution, or premixed aqueous solution, may have
been further diluted with dextrose 5% in water or sodium chloride 0.9% injection
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Arm title
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Treatment Arm 2 | ||||||||||||||||||||||||||||||
Arm description |
Treatment Arm 2 (40 patients planned) received, sequentially, carboplatin AUC 6 administered IV every 3 weeks (21 days) for 6 cycles, followed by paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles. | ||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
carboplatin + paclitaxel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Paclitaxel was diluted before infusion in 0.9% sodium chloride injection, 5% dextrose injection,
5% dextrose and 0.9% sodium chloride injection, or 5% dextrose in Ringer's injection to a final
concentration of 0.3 to 1.2 mg/mL.
Carboplatin powder was reconstituted for injection with sterile water for injection, dextrose 5%
in water, or sodium chloride 0.9 concentration of 10 mg/mL. Reconstituted solution, or premixed aqueous solution, may have
been further diluted with dextrose 5% in water or sodium chloride 0.9% injection.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment Arm 1
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Reporting group description |
Treatment Arm 1 (40 patients planned) received, sequentially on the same day, carboplatin area under the curve (AUC) 6 administered intravenously (IV) every 3 weeks (21 days) for 6 cycles, paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles, and oregovomab 2 mg infused IV over 20 minutes administered during the first, third, and fifth cycles. Patients in Arm 1 also received oregovomab as monotherapy 12 weeks after the fifth cycle. At the discretion of the investigator, treatment with oregovomab may have been discontinued for patients who experienced an allergic event. No other oregovomab dosage modification was permitted without prior approval from the medical monitor. Oregovomab, when dosed at 2 mg, has been demonstrated to induce cross-presentation of CA125 peptide fragments and induce a CA125-specific cellular immune response and has been well tolerated in clinical trials. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment Arm 2
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Reporting group description |
Treatment Arm 2 (40 patients planned) received, sequentially, carboplatin AUC 6 administered IV every 3 weeks (21 days) for 6 cycles, followed by paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment Arm 1
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Reporting group description |
Treatment Arm 1 (40 patients planned) received, sequentially on the same day, carboplatin area under the curve (AUC) 6 administered intravenously (IV) every 3 weeks (21 days) for 6 cycles, paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles, and oregovomab 2 mg infused IV over 20 minutes administered during the first, third, and fifth cycles. Patients in Arm 1 also received oregovomab as monotherapy 12 weeks after the fifth cycle. At the discretion of the investigator, treatment with oregovomab may have been discontinued for patients who experienced an allergic event. No other oregovomab dosage modification was permitted without prior approval from the medical monitor. Oregovomab, when dosed at 2 mg, has been demonstrated to induce cross-presentation of CA125 peptide fragments and induce a CA125-specific cellular immune response and has been well tolerated in clinical trials. | ||
Reporting group title |
Treatment Arm 2
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Reporting group description |
Treatment Arm 2 (40 patients planned) received, sequentially, carboplatin AUC 6 administered IV every 3 weeks (21 days) for 6 cycles, followed by paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles. |
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End point title |
Comparison of CA 125 cellular immune response | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
28 weeks
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Statistical analysis title |
Statistical Analysis Plan (SAP) | ||||||||||||
Statistical analysis description |
For qualitative variables, the chi-square test was applied. For continuous variables, the Student’s t-test or Wilcoxon-Mann-Whitney test (according to normality of the data) was applied. In both cases, the H0 (null hypothesis) was that there were no differences between groups for a determinate variable. The level of significance was α = 0.05.
All descriptive statistical analyses were performed using SAS version 9.4 or later, unless otherwise noted.
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Comparison groups |
Treatment Arm 1 v Treatment Arm 2
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Parameter type |
percentage | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
22 December 2011 to 27 December 2017
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Adverse event reporting additional description |
Monitoring for adverse experiences was conducted by the investigator throughout the study and the results recorded on the AE Report Form.The investigator graded all adverse experiences as to their severity according to the WHO Toxicity Guidelines.All patients followed for AE/SAE for 30days following the last dose or until the date of treatment exit
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
Treatment Group
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Reporting group description |
Arm 1: Oregovomab in combination with first-line chemotherapy (carboplatin and pacitaxel) in patients with advanced epithelial ovarian, adnexal, or peritoneal carcinoma. Arm 1 (40 patients planned) received, sequentially on the same day, carboplatin area under the curve (AUC) 6 administered intravenously (IV) every 3 weeks (21 days) for 6 cycles, paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles, and oregovomab 2 mg infused IV over 20 minutes administered during the first, third, and fifth cycles. Patients in Arm 1 also received oregovomab as monotherapy 12 weeks after the fifth cycle. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group
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Reporting group description |
Arm 2: First-line chemotherapy (carboplatin and pacitaxel) in patients with advanced epithelial ovarian, adnexal, or peritoneal carcinoma. Treatment Arm 2 (40 patients planned) received, sequentially, carboplatin AUC 6 administered IV every 3 weeks (21 days) for 6 cycles, followed by paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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29 Feb 2012 |
Updated Protocol |
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21 Jul 2012 |
Updated Protocol |
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07 Sep 2012 |
Updated Protocol |
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08 Feb 2013 |
Updated Protocol |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/31916979 |