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Trial record 97 of 326 for:    clonidine

Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis

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ClinicalTrials.gov Identifier: NCT01385748
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : August 9, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Onxeo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Oral Mucositis
Interventions Drug: Clonidine Lauriad® 50µg
Drug: Clonidine Lauriad® 100µg
Drug: Placebo Lauriad®
Enrollment 183
Recruitment Details 183 participants were randomized from 6 countries during 4 years
Pre-assignment Details  
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad®
Hide Arm/Group Description Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Period Title: Overall Study
Started 56 65 62
Completed 41 51 49
Not Completed 15 14 13
Reason Not Completed
Withdrawal by Subject             7             4             5
Noncompliance             3             1             6
Not specified             1             7             1
Adverse Event             4             2             1
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad® Total
Hide Arm/Group Description Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks Clonidine Lauriad® 100 µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 56 65 62 183
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 56 participants 65 participants 62 participants 183 participants
58.8
(30 to 79)
55.7
(22 to 75)
56.6
(33 to 72)
57.3
(22 to 79)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
18 to 64 years 43 58 50 151
65 to 84 years 13 7 12 32
85 years and over 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Female
16
  28.6%
16
  24.6%
13
  21.0%
45
  24.6%
Male
40
  71.4%
49
  75.4%
49
  79.0%
138
  75.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Caucasian 53 61 59 173
Other 2 4 3 9
Black 1 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Hungary 1 3 0 4
United States 0 2 4 6
France 31 27 30 88
Switzerland 0 2 0 2
Germany 10 11 10 31
Spain 14 20 18 52
Eastern Cooperative Oncology Group (ECOG) Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Score 0 42 41 42 125
Score 1 14 22 20 56
Score 2 0 2 0 2
[1]
Measure Description: ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead.
Disease location   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Oral cavity 26 37 30 93
Oropharynx 19 17 21 57
Hypopharynx 4 2 2 8
Larynx 4 6 5 15
Oral cavity/oropharynx 0 1 1 2
Oral cavity/hypopharynx 0 1 1 2
Oral cavity/larynx 1 0 0 1
Oropharynx/hypopharynx 2 1 1 4
Oropharynx/larynx 0 0 1 1
[1]
Measure Description: The location of the squamous cell carcinoma.
Disease location in oral cavity or oropharynx   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Yes 48 57 55 160
No 8 8 7 23
[1]
Measure Description: Location of the squamous cell carcinoma (in oral cavity or oropharynx).
Mucosal irritation   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Yes 2 2 1 5
No 53 63 61 177
Missing 1 0 0 1
[1]
Measure Description: The number of participants with mucosal irritation at baseline.
Tooth extraction   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Yes 30 32 32 94
No 25 32 30 87
Missing 1 1 0 2
[1]
Measure Description: The number of participants having undergone tooth extraction at baseline.
Oral infection   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Yes 0 1 0 1
No 55 64 62 181
Missing 1 0 0 1
[1]
Measure Description: The number of participants presenting with oral infection at baseline.
Prior surgery   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Yes 55 64 61 180
No 1 1 1 3
[1]
Measure Description: The number of participants having undergone prior surgery.
Prior radiotherapy and/or chemotherapy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 65 participants 62 participants 183 participants
Yes 54 62 61 177
No 2 3 1 6
[1]
Measure Description: The number of participants previously treated with radiotherapy and/or chemotherapy.
Height  
Median (Full Range)
Unit of measure:  Cm
Number Analyzed 56 participants 65 participants 62 participants 183 participants
171
(153 to 182)
170
(147 to 186)
172
(145 to 190)
171
(145 to 190)
Weight  
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 56 participants 65 participants 62 participants 183 participants
71.3
(44 to 130)
66
(43 to 123)
69
(48 to 115)
69
(43 to 130)
Body Mass Index (BMI)  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 56 participants 65 participants 62 participants 183 participants
23.7
(16.1 to 44.4)
23.66
(16.8 to 40.3)
23.33
(16.9 to 43.8)
23.59
(16.1 to 44.4)
Disease duration   [1] 
Median (Full Range)
Unit of measure:  Months
Number Analyzed 56 participants 65 participants 62 participants 183 participants
2
(1 to 14)
2
(1 to 99)
2
(0 to 7)
2
(0 to 99)
[1]
Measure Description: Duration of the squamous cell carcinoma at baseline.
1.Primary Outcome
Title Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed
Hide Description The primary endpoint planned in the protocol was the percentage of participants with an oral mucositis score greater than or equal to 3 using the WHO oral mucositis severity scale at a cumulative radiation dose of 50 Gy. This was modified by protocol amendment to the cumulative radiation dose at which a WHO score greater than or equal to 3 was first observed. This change was made to account for the fact that in real practice most patients receive a cumulative dose between 60 and 70 Gy. The presence of grade 3 or 4 oral mucositis was assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = oral ulcers, liquid diet only; WHO score 4 = oral alimentation impossible. Each assessment was associated with the actual cumulative dose of radiotherapy.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted on the Intent to treat population, defined as all participants who received at least one dose of investigational drug.
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Hide Arm/Group Description:
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
Overall Number of Participants Analyzed 56 65 62 121
Median (95% Confidence Interval)
Unit of Measure: Cumulative radiation dose (Gy)
66 [1] 
(44 to NA)
56 [1] 
(44 to NA)
48
(42 to 61.6)
60 [1] 
(48 to NA)
[1]
NA indicates that the upper limit of the confidence interval was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 50 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.165
Comments [Not Specified]
Method Log Rank
Comments The log rank test at 5% significance level was used.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.677
Confidence Interval (2-Sided) 95%
0.387 to 1.186
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 100 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.421
Comments [Not Specified]
Method Log Rank
Comments The log rank test at 5% significance level was used.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.817
Confidence Interval (2-Sided) 95%
0.495 to 1.35
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Lauriad®, Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.211
Comments [Not Specified]
Method Log Rank
Comments The log rank test at 5% significance level was used.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.754
Confidence Interval (2-Sided) 95%
0.484 to 1.175
Estimation Comments [Not Specified]
2.Secondary Outcome
Title At Least One Opioid Use (Class 3 Analgesic)
Hide Description Opioid use was recorded twice weekly during the active phase (radiotherapy)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad®
Hide Arm/Group Description:
Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Overall Number of Participants Analyzed 56 65 62
Measure Type: Number
Unit of Measure: participants
Missing 2 1 0
Yes 23 30 30
No 31 34 32
3.Secondary Outcome
Title Opioid Use: Minimal Total Cumulative Dose Administered (Mean, Standard Deviation)
Hide Description Opioid use was recorded twice weekly for up to 8 weeks during the active phase (radiotherapy). The sum of non-missing total cumulative doses across all class 3 analgesics recorded for the considered participant is reported.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one use of an opioid during the active phase with evaluable data.
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Hide Arm/Group Description:
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
Overall Number of Participants Analyzed 20 24 29 44
Mean (Standard Deviation)
Unit of Measure: morphine dose equivalent
469.31  (633.51) 415.49  (490.55) 624.94  (958.81) 439.95  (553.88)
4.Secondary Outcome
Title Opioid Use: Minimal Total Cumulative Dose Administered (Median, Range)
Hide Description Opioid use was recorded twice weekly for up to 8 weeks during the active phase (radiotherapy). The sum of non-missing total cumulative doses across all class 3 analgesics recorded for the considered participant is reported.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one use of an opioid during the active phase with evaluable data.
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Hide Arm/Group Description:
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
Overall Number of Participants Analyzed 20 24 29 44
Median (Full Range)
Unit of Measure: morphine dose equivalent
183.6
(12 to 2249.1)
174
(15 to 1804)
215
(20 to 3672)
178.65
(12 to 2249.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 50 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.807
Comments Significance threshold = 5%
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 100 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.971
Comments Significance threshold = 5%
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival
Hide Description After the end-of study visit, the investigator center collects OS follow-up data for each patient who has consented to participate in the follow-up data collection. the OS follow-up period was still ongoing at time of the primary analysis and ended in Nov 2016. The analysis was condicted on the ITT population. The overall survival was evaluate every 6 months after last subject completed in patients who has consented to participate .
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The population for the 2-year OS follow-up was the ITT defined as all patients who received at least 1 dose of investigational drug.
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Hide Arm/Group Description:
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
Overall Number of Participants Analyzed 56 65 62 121
Median (95% Confidence Interval)
Unit of Measure: months
47 [1] 
(17.3 to NA)
58.8 [1] 
(35.9 to NA)
41.8 [1] 
(27.7 to NA)
58.8 [1] 
(32.3 to NA)
[1]
NA indicate that the upper limit of the confidence interval was not reached
6.Other Pre-specified Outcome
Title Time to Onset of Severe Oral Mucositis
Hide Description Time to onset is the duration until first Severe Oral Mucositis. Severe Oral Mucositis was defined as a Grade 3 or Grade 4 score on the World Health Organization (WHO) oral mucositis severity scale. Participants were assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = ulcers, extensive erythema, and the inability of the participant to swallow a solid diet; WHO score 4 = mucositis to the extent that alimentation was not possible.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Hide Arm/Group Description:
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
Overall Number of Participants Analyzed 56 65 62 121
Median (95% Confidence Interval)
Unit of Measure: weeks
6.4 [1] 
(4.6 to NA)
6
(4.6 to 8)
5.1
(4.4 to 6.9)
6.4 [1] 
(5.1 to NA)
[1]
NA indicates that the upper limit of the confidence interval was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 50 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.199
Comments Significance threshold = 5%
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.698
Confidence Interval (2-Sided) 95%
0.398 to 1.223
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 100 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.424
Comments [Not Specified]
Method Log Rank
Comments Significance threshold = 5%
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.817
Confidence Interval (2-Sided) 95%
0.493 to 1.353
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Lauriad®, Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.235
Comments [Not Specified]
Method Log Rank
Comments Significance threshold = 5%
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.764
Confidence Interval (2-Sided) 95%
0.489 to 1.193
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title The Maximum Severity of Oral Mucositis
Hide Description Participants were assessed using the World Health Organization (WHO) oral mucositis severity scale twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. The WHO scores were as follows: 0 = None; 1 = oral soreness, erythema; 2 = oral erythema, ulcers, solid diet tolerated; 3 = oral ulcers, liquid diet only; 4 = oral alimentation impossible. The maximum severity was the maximum score reported during the active phase.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Hide Arm/Group Description:
Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
Overall Number of Participants Analyzed 56 65 62 121
Measure Type: Number
Unit of Measure: participants
Grade 0 7 6 4 13
Grade 1 9 7 9 16
Grade 2 15 20 11 35
Grade 3 17 20 30 37
Grade 4 6 10 6 16
No value during the concerned period 2 2 2 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 50 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method Kruskal-Wallis
Comments Significance threshold = 5%
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 100 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Kruskal-Wallis
Comments Significance threshold = 5%
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Lauriad®, Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.295
Comments [Not Specified]
Method Kruskal-Wallis
Comments Significance threshold = 5%
8.Other Pre-specified Outcome
Title The Overall Incidence of Grade 3/4 Mucositis During the Active Phase.
Hide Description The presence of grade 3 or 4 oral mucositis on the World Health Organization (WHO) oral mucositis severity scale was assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = ulcers, extensive erythema, and the inability of the participant to swallow a solid diet; WHO score 4 = mucositis to the extent that alimentation was not possible.The number of participants with at least one Grade 3 or Grade 4 mucositis score during the active phase is reported.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing = participants without a WHO score during the active phase
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Hide Arm/Group Description:
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
Overall Number of Participants Analyzed 56 65 62 121
Measure Type: Number
Unit of Measure: participants
Missing 2 2 2 4
No 31 33 24 64
Yes 23 30 36 53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 50 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments Significance threshold = 5%
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 100 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.169
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Lauriad®, Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method Chi-squared
Comments Significance threshold = 5%
9.Other Pre-specified Outcome
Title Salivary Flow Assessment Using the National Cancer Institute-Common Terminology Criteria (NCI-CTC) for Xerostomia: Time to First Grade 2 or Higher
Hide Description Salivary flow was assessed and scored by the investigator weekly using the NCI-CTC scale for xerostomia for up to 8 weeks during the active phase (radiotherapy). Time to appearance of Grade 2 or higher on the following 4-point scoring scale is reported: 0 = normal; 1 = symptomatic (dry or thick saliva) without significant dietary alteration (unstimulated saliva flow greater than 0.2 mL/minute); 2 = symptomatic and significant oral intake alterations (e.g. copious water, other lubricants, diet limited to purees and/or soft, moist foods) (unstimulated saliva 0.1 to 0.2 mL/minute); and 3 = symptoms leading to inability to adequately aliment orally, intravenous fluids, tube feedings, or total parenteral nutrition indicated (unstimulated saliva < 0.1 mL/minute).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Two of the 183 participants received study treatment but withdrew early without any safety assessments (1 in the clonidine Lauriad 50 μg group and 1 in the clonidine Lauriad 100 μg group). The safety population therefore included 181 participants.
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Hide Arm/Group Description:
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
Overall Number of Participants Analyzed 55 64 62 119
Median (95% Confidence Interval)
Unit of Measure: weeks
6
(4.9 to 9.4)
7.4 [1] 
(6 to NA)
5.1
(4.1 to 7.1)
7.1
(5.7 to 9.4)
[1]
NA indicates that the upper limit of the confidence interval was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 50 µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.388
Comments [Not Specified]
Method Log Rank
Comments Significance threshold = 5%
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.824
Confidence Interval (2-Sided) 95%
0.484 to 1.401
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clonidine Lauriad® 100µg, Placebo Lauriad®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method Log Rank
Comments Significance threshold = 5%
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.601
Confidence Interval (2-Sided) 95%
0.357 to 1.012
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Lauriad®, Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments [Not Specified]
Method Log Rank
Comments Significance threshold = 5%
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.692
Confidence Interval (2-Sided) 95%
0.444 to 1.078
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Overall Treatment Compliance According to the Patient Diary
Hide Description All participants complete a daily questionnaire during the active phase (radiotherapy). Compliance = [ number of tablets / (end date of treatment - start date treatment + 1 ) ] * 100. The "number of tablets" is the number of days with a tablet applied and treatment start and end dates are the first and last dates of the patient diary with a tablet applied.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data.
Arm/Group Title Clonidine Lauriad® 50 µg Clonidine Lauriad® 100 µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Hide Arm/Group Description:
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
Overall Number of Participants Analyzed 55 64 62 119
Mean (Standard Deviation)
Unit of Measure: percentage of compliance
94.28  (8.23) 93.12  (11.89) 96.12  (5.59) 93.66  (10.34)
Time Frame [Not Specified]
Adverse Event Reporting Description Two of the 183 participants received study treatment but withdrew early without any safety assessments (1 in the clonidine Lauriad 50 μg group and 1 in the clonidine Lauriad 100 μg group). The safety population therefore included 181 participants.
 
Arm/Group Title Clonidine Lauriad® 50µg Clonidine Lauriad® 100µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Hide Arm/Group Description Clonidine Lauriad® 50µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks Clonidine Lauriad® 100µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks
All-Cause Mortality
Clonidine Lauriad® 50µg Clonidine Lauriad® 100µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clonidine Lauriad® 50µg Clonidine Lauriad® 100µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/55 (29.09%)      21/64 (32.81%)      14/62 (22.58%)      37/119 (31.09%)    
Blood and lymphatic system disorders         
Neutropenia  1  1/55 (1.82%)  1 1/64 (1.56%)  1 0/62 (0.00%)  0 2/119 (1.68%)  2
Febrile neutropenia  1  0/55 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 1/119 (0.84%)  1
Haemolytic anemia  1  0/55 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 1/119 (0.84%)  1
Leukopenia  1  0/55 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 1/119 (0.84%)  1
Thromoboctyopenia  1  0/55 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 1/119 (0.84%)  1
Gastrointestinal disorders         
Stomatitis  1  2/55 (3.64%)  2 4/64 (6.25%)  4 2/62 (3.23%)  2 6/119 (5.04%)  6
Dysphagia  1  2/55 (3.64%)  2 2/64 (3.13%)  2 2/62 (3.23%)  2 4/119 (3.36%)  4
Vomiting  1  1/55 (1.82%)  1 3/64 (4.69%)  3 0/62 (0.00%)  0 4/119 (3.36%)  4
Nausea  1  0/55 (0.00%)  0 2/64 (3.13%)  2 0/62 (0.00%)  0 2/119 (1.68%)  2
Odynophagia  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Oral pain  1  0/55 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 1/119 (0.84%)  1
General disorders         
General physical health deterioration  1  4/55 (7.27%)  4 1/64 (1.56%)  1 0/62 (0.00%)  0 5/119 (4.20%)  5
Asthenia  1  1/55 (1.82%)  1 0/64 (0.00%)  0 1/62 (1.61%)  1 1/119 (0.84%)  1
Localised oedema  1  0/55 (0.00%)  0 1/64 (1.56%)  1 1/62 (1.61%)  1 1/119 (0.84%)  1
Pyrexia  1  1/55 (1.82%)  1 1/64 (1.56%)  1 0/62 (0.00%)  0 2/119 (1.68%)  2
Pain  1  0/55 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/119 (0.00%)  0
Infections and infestations         
Infection  1  2/55 (3.64%)  2 1/64 (1.56%)  1 0/62 (0.00%)  0 3/119 (2.52%)  3
Bronchitis  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Bronchopneumonia  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Hepatitis viral  1  0/55 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/119 (0.00%)  0
Lung infection  1  0/55 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/119 (0.00%)  0
Pneumonia  1  0/55 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 1/119 (0.84%)  1
Respiratory tract infection  1  0/55 (0.00%)  0 1/64 (1.56%)  3 0/62 (0.00%)  0 1/119 (0.84%)  3
Staphylococcal sepsis  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Injury, poisoning and procedural complications         
Infusion related reaction  1  0/55 (0.00%)  0 1/64 (1.56%)  1 1/62 (1.61%)  1 1/119 (0.84%)  1
Postoperative wound complication  1  0/55 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/119 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration  1  1/55 (1.82%)  1 2/64 (3.13%)  3 3/62 (4.84%)  4 3/119 (2.52%)  4
Malnutrition  1  0/55 (0.00%)  0 2/64 (3.13%)  2 1/62 (1.61%)  1 2/119 (1.68%)  2
Abnormal loss of weight  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Cachexia  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Decreased appetite  1  0/55 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/119 (0.00%)  0
Hypoglycaemia  1  0/55 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/119 (0.00%)  0
Hyponatraemia  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Musculoskeletal and connective tissue disorders         
Muscular weakness  1  0/55 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/119 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant neoplasm progression  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Metastases to liver  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Nervous system disorders         
Dizziness  1  0/55 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/119 (0.00%)  0
Renal and urinary disorders         
Renal failure  1  1/55 (1.82%)  1 3/64 (4.69%)  5 3/62 (4.84%)  4 4/119 (3.36%)  6
Renal failure acute  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Reproductive system and breast disorders         
Testicular oedema  1  0/55 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/119 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  1/55 (1.82%)  1 1/64 (1.56%)  1 0/62 (0.00%)  0 2/119 (1.68%)  2
Pulmonary mass  1  0/55 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/119 (0.00%)  0
Respiratory distress  1  0/55 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 1/119 (0.84%)  1
Vascular disorders         
Hypotension  1  2/55 (3.64%)  2 0/64 (0.00%)  0 0/62 (0.00%)  0 2/119 (1.68%)  2
Circulatory collapse  1  0/55 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 1/119 (0.84%)  1
Syncope  1  1/55 (1.82%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/119 (0.84%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clonidine Lauriad® 50µg Clonidine Lauriad® 100µg Placebo Lauriad® Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/55 (87.27%)      60/64 (93.75%)      61/62 (98.39%)      108/119 (90.76%)    
Blood and lymphatic system disorders         
Anaemia  1  9/55 (16.36%)  11 12/64 (18.75%)  16 11/62 (17.74%)  12 21/119 (17.65%)  27
Leukopenia  1  10/55 (18.18%)  17 12/64 (18.75%)  19 8/62 (12.90%)  11 22/119 (18.49%)  36
Neutropenia  1  7/55 (12.73%)  9 12/64 (18.75%)  15 8/62 (12.90%)  9 19/119 (15.97%)  24
Lymphopenia  1  7/55 (12.73%)  10 8/64 (12.50%)  12 5/62 (8.06%)  10 15/119 (12.61%)  22
Thrombocytopenia  1  6/55 (10.91%)  13 6/64 (9.38%)  11 4/62 (6.45%)  4 12/119 (10.08%)  24
Ear and labyrinth disorders         
Tinnitus  1  2/55 (3.64%)  2 4/64 (6.25%)  5 3/62 (4.84%)  3 6/119 (5.04%)  7
Gastrointestinal disorders         
Nausea  1  29/55 (52.73%)  63 29/64 (45.31%)  41 44/62 (70.97%)  82 58/119 (48.74%)  104
Dysphagia  1  18/55 (32.73%)  25 19/64 (29.69%)  23 29/62 (46.77%)  40 37/119 (31.09%)  48
Dry mouth  1  22/55 (40.00%)  26 17/64 (26.56%)  21 17/62 (27.42%)  22 39/119 (32.77%)  47
Vomiting  1  14/55 (25.45%)  26 15/64 (23.44%)  20 24/62 (38.71%)  32 29/119 (24.37%)  46
Constipation  1  18/55 (32.73%)  20 17/64 (26.56%)  19 16/62 (25.81%)  16 35/119 (29.41%)  39
Oral pain  1  16/55 (29.09%)  40 19/64 (29.69%)  70 16/62 (25.81%)  40 35/119 (29.41%)  110
Dysgeusia  1  14/55 (25.45%)  15 11/64 (17.19%)  13 12/62 (19.35%)  12 25/119 (21.01%)  28
Diarrhoea  1  7/55 (12.73%)  15 14/64 (21.88%)  22 13/62 (20.97%)  22 21/119 (17.65%)  37
Odynophagia  1  7/55 (12.73%)  11 14/64 (21.88%)  21 8/62 (12.90%)  22 21/119 (17.65%)  32
Stomatitis  1  6/55 (10.91%)  15 8/64 (12.50%)  18 8/62 (12.90%)  17 14/119 (11.76%)  33
Dyspepsia  1  1/55 (1.82%)  1 6/64 (9.38%)  6 6/62 (9.68%)  6 7/119 (5.88%)  7
Abdominal pain upper  1  2/55 (3.64%)  2 2/64 (3.13%)  3 5/62 (8.06%)  5 4/119 (3.36%)  5
Aptyalism  1  1/55 (1.82%)  1 4/64 (6.25%)  5 3/62 (4.84%)  4 5/119 (4.20%)  6
Salivary hypersecretion  1  3/55 (5.45%)  3 0/64 (0.00%)  0 2/62 (3.23%)  2 3/119 (2.52%)  3
General disorders         
Asthenia  1  9/55 (16.36%)  12 11/64 (17.19%)  14 14/62 (22.58%)  18 20/119 (16.81%)  26
Mucosal inflammation  1  8/55 (14.55%)  21 11/64 (17.19%)  19 6/62 (9.68%)  12 19/119 (15.97%)  40
Pyrexia  1  5/55 (9.09%)  5 10/64 (15.63%)  13 3/62 (4.84%)  3 15/119 (12.61%)  18
Fatigue  1  5/55 (9.09%)  5 5/64 (7.81%)  6 8/62 (12.90%)  10 10/119 (8.40%)  11
General physical health deterioration  1  3/55 (5.45%)  4 1/64 (1.56%)  2 2/62 (3.23%)  2 4/119 (3.36%)  6
Pain  1  3/55 (5.45%)  3 2/64 (3.13%)  3 4/62 (6.45%)  4 5/119 (4.20%)  6
Oedema  1  0/55 (0.00%)  0 4/64 (6.25%)  4 0/62 (0.00%)  0 4/119 (3.36%)  4
Infections and infestations         
Oral candidiasis  1  3/55 (5.45%)  4 10/64 (15.63%)  11 9/62 (14.52%)  13 13/119 (10.92%)  15
Fungal infection  1  2/55 (3.64%)  2 2/64 (3.13%)  2 7/62 (11.29%)  7 4/119 (3.36%)  4
Candida infection  1  2/55 (3.64%)  2 2/64 (3.13%)  2 4/62 (6.45%)  4 4/119 (3.36%)  4
Injury, poisoning and procedural complications         
Radiation skin injury  1  14/55 (25.45%)  24 22/64 (34.38%)  45 24/62 (38.71%)  35 36/119 (30.25%)  69
Investigations         
Blood creatinine increased  1  7/55 (12.73%)  7 3/64 (4.69%)  3 7/62 (11.29%)  7 10/119 (8.40%)  10
Metabolism and nutrition disorders         
Abnormal loss of weight  1  4/55 (7.27%)  4 11/64 (17.19%)  13 17/62 (27.42%)  19 15/119 (12.61%)  17
Decreased appetite  1  6/55 (10.91%)  8 8/64 (12.50%)  11 5/62 (8.06%)  6 14/119 (11.76%)  19
Musculoskeletal and connective tissue disorders         
Musculoskeletal pain  1  3/55 (5.45%)  3 1/64 (1.56%)  1 2/62 (3.23%)  3 4/119 (3.36%)  4
Nervous system disorders         
Headache  1  5/55 (9.09%)  6 2/64 (3.13%)  2 9/62 (14.52%)  9 7/119 (5.88%)  8
Dizziness  1  2/55 (3.64%)  2 6/64 (9.38%)  10 2/62 (3.23%)  3 8/119 (6.72%)  12
Psychiatric disorders         
Anxiety  1  5/55 (9.09%)  5 1/64 (1.56%)  1 3/62 (4.84%)  4 6/119 (5.04%)  6
Renal and urinary disorders         
Renal failure  1  3/55 (5.45%)  3 2/64 (3.13%)  2 1/62 (1.61%)  1 5/119 (4.20%)  5
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/55 (5.45%)  3 5/64 (7.81%)  6 8/62 (12.90%)  8 8/119 (6.72%)  9
Oropharyngeal pain  1  4/55 (7.27%)  4 3/64 (4.69%)  6 3/62 (4.84%)  4 7/119 (5.88%)  10
Dysphonia  1  3/55 (5.45%)  3 3/64 (4.69%)  3 3/62 (4.84%)  3 6/119 (5.04%)  6
Skin and subcutaneous tissue disorders         
Dermatitis  1  11/55 (20.00%)  27 9/64 (14.06%)  17 8/62 (12.90%)  17 20/119 (16.81%)  44
Erythema  1  4/55 (7.27%)  5 4/64 (6.25%)  4 3/62 (4.84%)  3 8/119 (6.72%)  9
Vascular disorders         
Hypotension  1  3/55 (5.45%)  4 4/64 (6.25%)  4 1/62 (1.61%)  1 7/119 (5.88%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Berangere Vasseur, MD
Organization: Onxeo
Phone: +33 (0)1 45 58 76 00
EMail: b.vasseur@onxeo.com
Layout table for additonal information
Responsible Party: Onxeo
ClinicalTrials.gov Identifier: NCT01385748     History of Changes
Other Study ID Numbers: BA2009/28/01
First Submitted: June 29, 2011
First Posted: June 30, 2011
Results First Submitted: October 27, 2016
Results First Posted: August 9, 2017
Last Update Posted: November 28, 2017