Trial Outcomes & Findings for Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis (NCT NCT01385748)
NCT ID: NCT01385748
Last Updated: 2017-11-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
8 weeks
Results posted on
2017-11-28
Participant Flow
183 participants were randomized from 6 countries during 4 years
Participant milestones
| Measure |
Clonidine Lauriad® 50 µg
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
65
|
62
|
|
Overall Study
COMPLETED
|
41
|
51
|
49
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
13
|
Reasons for withdrawal
| Measure |
Clonidine Lauriad® 50 µg
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
5
|
|
Overall Study
Noncompliance
|
3
|
1
|
6
|
|
Overall Study
Other
|
1
|
7
|
1
|
|
Overall Study
Adverse Event
|
4
|
2
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
Baseline characteristics by cohort
| Measure |
Clonidine Lauriad® 50 µg
n=56 Participants
Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=65 Participants
Clonidine Lauriad® 100 µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
n=5 Participants
|
55.7 years
n=7 Participants
|
56.6 years
n=5 Participants
|
57.3 years
n=4 Participants
|
|
Age, Customized
18 to 64 years
|
43 participants
n=5 Participants
|
58 participants
n=7 Participants
|
50 participants
n=5 Participants
|
151 participants
n=4 Participants
|
|
Age, Customized
65 to 84 years
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Age, Customized
85 years and over
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
53 participants
n=5 Participants
|
61 participants
n=7 Participants
|
59 participants
n=5 Participants
|
173 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
France
|
31 participants
n=5 Participants
|
27 participants
n=7 Participants
|
30 participants
n=5 Participants
|
88 participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
14 participants
n=5 Participants
|
20 participants
n=7 Participants
|
18 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score
Score 0
|
42 participants
n=5 Participants
|
41 participants
n=7 Participants
|
42 participants
n=5 Participants
|
125 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score
Score 1
|
14 participants
n=5 Participants
|
22 participants
n=7 Participants
|
20 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score
Score 2
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Disease location
Oral cavity
|
26 participants
n=5 Participants
|
37 participants
n=7 Participants
|
30 participants
n=5 Participants
|
93 participants
n=4 Participants
|
|
Disease location
Oropharynx
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
21 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Disease location
Hypopharynx
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Disease location
Larynx
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Disease location
Oral cavity/oropharynx
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Disease location
Oral cavity/hypopharynx
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Disease location
Oral cavity/larynx
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Disease location
Oropharynx/hypopharynx
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Disease location
Oropharynx/larynx
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Disease location in oral cavity or oropharynx
Yes
|
48 participants
n=5 Participants
|
57 participants
n=7 Participants
|
55 participants
n=5 Participants
|
160 participants
n=4 Participants
|
|
Disease location in oral cavity or oropharynx
No
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Mucosal irritation
Yes
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Mucosal irritation
No
|
53 participants
n=5 Participants
|
63 participants
n=7 Participants
|
61 participants
n=5 Participants
|
177 participants
n=4 Participants
|
|
Mucosal irritation
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Tooth extraction
Yes
|
30 participants
n=5 Participants
|
32 participants
n=7 Participants
|
32 participants
n=5 Participants
|
94 participants
n=4 Participants
|
|
Tooth extraction
No
|
25 participants
n=5 Participants
|
32 participants
n=7 Participants
|
30 participants
n=5 Participants
|
87 participants
n=4 Participants
|
|
Tooth extraction
Missing
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Oral infection
Yes
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Oral infection
No
|
55 participants
n=5 Participants
|
64 participants
n=7 Participants
|
62 participants
n=5 Participants
|
181 participants
n=4 Participants
|
|
Oral infection
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Prior surgery
Yes
|
55 participants
n=5 Participants
|
64 participants
n=7 Participants
|
61 participants
n=5 Participants
|
180 participants
n=4 Participants
|
|
Prior surgery
No
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Prior radiotherapy and/or chemotherapy
Yes
|
54 participants
n=5 Participants
|
62 participants
n=7 Participants
|
61 participants
n=5 Participants
|
177 participants
n=4 Participants
|
|
Prior radiotherapy and/or chemotherapy
No
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Height
|
171 cm
n=5 Participants
|
170 cm
n=7 Participants
|
172 cm
n=5 Participants
|
171 cm
n=4 Participants
|
|
Weight
|
71.3 kg
n=5 Participants
|
66 kg
n=7 Participants
|
69 kg
n=5 Participants
|
69 kg
n=4 Participants
|
|
Body Mass Index (BMI)
|
23.7 kg/m^2
n=5 Participants
|
23.66 kg/m^2
n=7 Participants
|
23.33 kg/m^2
n=5 Participants
|
23.59 kg/m^2
n=4 Participants
|
|
Disease duration
|
2 months
n=5 Participants
|
2 months
n=7 Participants
|
2 months
n=5 Participants
|
2 months
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The analysis was conducted on the Intent to treat population, defined as all participants who received at least one dose of investigational drug.
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.
Outcome measures
| Measure |
Clonidine Lauriad® 50 µg
n=56 Participants
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=65 Participants
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=121 Participants
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.
|
|---|---|---|---|---|
|
Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed
|
66 Cumulative radiation dose (Gy)
Interval 44.0 to
NA indicates that the upper limit of the confidence interval was not reached.
|
56 Cumulative radiation dose (Gy)
Interval 44.0 to
NA indicates that the upper limit of the confidence interval was not reached.
|
48 Cumulative radiation dose (Gy)
Interval 42.0 to 61.6
|
60 Cumulative radiation dose (Gy)
Interval 48.0 to
NA indicates that the upper limit of the confidence interval was not reached.
|
SECONDARY outcome
Timeframe: 8 weeksOpioid use was recorded twice weekly during the active phase (radiotherapy)
Outcome measures
| Measure |
Clonidine Lauriad® 50 µg
n=56 Participants
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=65 Participants
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
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.
|
|---|---|---|---|---|
|
At Least One Opioid Use (Class 3 Analgesic)
Missing
|
2 participants
|
1 participants
|
0 participants
|
—
|
|
At Least One Opioid Use (Class 3 Analgesic)
Yes
|
23 participants
|
30 participants
|
30 participants
|
—
|
|
At Least One Opioid Use (Class 3 Analgesic)
No
|
31 participants
|
34 participants
|
32 participants
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants with at least one use of an opioid during the active phase with evaluable data.
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.
Outcome measures
| Measure |
Clonidine Lauriad® 50 µg
n=20 Participants
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=24 Participants
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=29 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=44 Participants
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.
|
|---|---|---|---|---|
|
Opioid Use: Minimal Total Cumulative Dose Administered (Mean, Standard Deviation)
|
469.31 morphine dose equivalent
Standard Deviation 633.51
|
415.49 morphine dose equivalent
Standard Deviation 490.55
|
624.94 morphine dose equivalent
Standard Deviation 958.81
|
439.95 morphine dose equivalent
Standard Deviation 553.88
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants with at least one use of an opioid during the active phase with evaluable data.
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.
Outcome measures
| Measure |
Clonidine Lauriad® 50 µg
n=20 Participants
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=24 Participants
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=29 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=44 Participants
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.
|
|---|---|---|---|---|
|
Opioid Use: Minimal Total Cumulative Dose Administered (Median, Range)
|
183.6 morphine dose equivalent
Interval 12.0 to 2249.1
|
174 morphine dose equivalent
Interval 15.0 to 1804.0
|
215 morphine dose equivalent
Interval 20.0 to 3672.0
|
178.65 morphine dose equivalent
Interval 12.0 to 2249.1
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
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 .
Outcome measures
| Measure |
Clonidine Lauriad® 50 µg
n=56 Participants
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=65 Participants
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=121 Participants
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 Survival
|
47 months
Interval 17.3 to
NA indicate that the upper limit of the confidence interval was not reached
|
58.8 months
Interval 35.9 to
NA indicate that the upper limit of the confidence interval was not reached
|
41.8 months
Interval 27.7 to
NA indicate that the upper limit of the confidence interval was not reached
|
58.8 months
Interval 32.3 to
NA indicate that the upper limit of the confidence interval was not reached
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksTime 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.
Outcome measures
| Measure |
Clonidine Lauriad® 50 µg
n=56 Participants
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=65 Participants
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=121 Participants
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.
|
|---|---|---|---|---|
|
Time to Onset of Severe Oral Mucositis
|
6.4 weeks
Interval 4.6 to
NA indicates that the upper limit of the confidence interval was not reached.
|
6 weeks
Interval 4.6 to 8.0
|
5.1 weeks
Interval 4.4 to 6.9
|
6.4 weeks
Interval 5.1 to
NA indicates that the upper limit of the confidence interval was not reached.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksParticipants 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.
Outcome measures
| Measure |
Clonidine Lauriad® 50 µg
n=56 Participants
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=65 Participants
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=121 Participants
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.
|
|---|---|---|---|---|
|
The Maximum Severity of Oral Mucositis
Grade 0
|
7 participants
|
6 participants
|
4 participants
|
13 participants
|
|
The Maximum Severity of Oral Mucositis
Grade 1
|
9 participants
|
7 participants
|
9 participants
|
16 participants
|
|
The Maximum Severity of Oral Mucositis
Grade 2
|
15 participants
|
20 participants
|
11 participants
|
35 participants
|
|
The Maximum Severity of Oral Mucositis
Grade 3
|
17 participants
|
20 participants
|
30 participants
|
37 participants
|
|
The Maximum Severity of Oral Mucositis
Grade 4
|
6 participants
|
10 participants
|
6 participants
|
16 participants
|
|
The Maximum Severity of Oral Mucositis
No value during the concerned period
|
2 participants
|
2 participants
|
2 participants
|
4 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksPopulation: Missing = participants without a WHO score during the active phase
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.
Outcome measures
| Measure |
Clonidine Lauriad® 50 µg
n=56 Participants
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=65 Participants
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=121 Participants
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.
|
|---|---|---|---|---|
|
The Overall Incidence of Grade 3/4 Mucositis During the Active Phase.
No
|
31 participants
|
33 participants
|
24 participants
|
64 participants
|
|
The Overall Incidence of Grade 3/4 Mucositis During the Active Phase.
Missing
|
2 participants
|
2 participants
|
2 participants
|
4 participants
|
|
The Overall Incidence of Grade 3/4 Mucositis During the Active Phase.
Yes
|
23 participants
|
30 participants
|
36 participants
|
53 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Clonidine Lauriad® 50 µg
n=55 Participants
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=64 Participants
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=119 Participants
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.
|
|---|---|---|---|---|
|
Salivary Flow Assessment Using the National Cancer Institute-Common Terminology Criteria (NCI-CTC) for Xerostomia: Time to First Grade 2 or Higher
|
6 weeks
Interval 4.9 to 9.4
|
7.4 weeks
Interval 6.0 to
NA indicates that the upper limit of the confidence interval was not reached.
|
5.1 weeks
Interval 4.1 to 7.1
|
7.1 weeks
Interval 5.7 to 9.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksPopulation: Participants with evaluable data.
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.
Outcome measures
| Measure |
Clonidine Lauriad® 50 µg
n=55 Participants
Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100 µg
n=64 Participants
Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 Participants
Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=119 Participants
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 Treatment Compliance According to the Patient Diary
|
94.28 percentage of compliance
Standard Deviation 8.23
|
93.12 percentage of compliance
Standard Deviation 11.89
|
96.12 percentage of compliance
Standard Deviation 5.59
|
93.66 percentage of compliance
Standard Deviation 10.34
|
Adverse Events
Clonidine Lauriad® 50µg
Serious events: 16 serious events
Other events: 48 other events
Deaths: 0 deaths
Clonidine Lauriad® 100µg
Serious events: 21 serious events
Other events: 60 other events
Deaths: 0 deaths
Placebo Lauriad®
Serious events: 14 serious events
Other events: 61 other events
Deaths: 0 deaths
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
Serious events: 37 serious events
Other events: 108 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clonidine Lauriad® 50µg
n=55 participants at risk
Clonidine Lauriad® 50µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100µg
n=64 participants at risk
Clonidine Lauriad® 100µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 participants at risk
Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=119 participants at risk
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
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/55
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.00%
0/119
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Vascular disorders
Hypotension
|
3.6%
2/55 • Number of events 2
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
1.7%
2/119 • Number of events 2
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.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Vascular disorders
Syncope
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
1/55 • Number of events 1
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
1.7%
2/119 • Number of events 2
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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
Haemolytic anemia
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
Thromoboctyopenia
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Gastrointestinal disorders
Stomatitis
|
3.6%
2/55 • Number of events 2
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.
|
6.2%
4/64 • Number of events 4
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.
|
3.2%
2/62 • Number of events 2
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.
|
5.0%
6/119 • Number of events 6
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.
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
2/55 • Number of events 2
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.
|
3.1%
2/64 • Number of events 2
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.
|
3.2%
2/62 • Number of events 2
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.
|
3.4%
4/119 • Number of events 4
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.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/55 • Number of events 1
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.
|
4.7%
3/64 • Number of events 3
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.
|
0.00%
0/62
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.
|
3.4%
4/119 • Number of events 4
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/55
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.
|
3.1%
2/64 • Number of events 2
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.
|
0.00%
0/62
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.
|
1.7%
2/119 • Number of events 2
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.
|
|
Gastrointestinal disorders
Odynophagia
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
General disorders
General physical health deterioration
|
7.3%
4/55 • Number of events 4
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
4.2%
5/119 • Number of events 5
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.
|
|
General disorders
Asthenia
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
General disorders
Localised oedema
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 1
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
General disorders
Pyrexia
|
1.8%
1/55 • Number of events 1
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
1.7%
2/119 • Number of events 2
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.
|
|
General disorders
Pain
|
0.00%
0/55
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.00%
0/119
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.
|
|
Infections and infestations
Infection
|
3.6%
2/55 • Number of events 2
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
2.5%
3/119 • Number of events 3
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.
|
|
Infections and infestations
Bronchitis
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Infections and infestations
Bronchopneumonia
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/55
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.00%
0/119
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.
|
|
Infections and infestations
Lung infection
|
0.00%
0/55
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.00%
0/119
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 3
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 3
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.
|
|
Infections and infestations
Staphylococcal sepsis
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/55
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.
|
1.6%
1/64 • Number of events 1
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/55
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.00%
0/119
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/55 • Number of events 1
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.
|
3.1%
2/64 • Number of events 3
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.
|
4.8%
3/62 • Number of events 4
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.
|
2.5%
3/119 • Number of events 4
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.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/55
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.
|
3.1%
2/64 • Number of events 2
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.
|
1.6%
1/62 • Number of events 1
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.
|
1.7%
2/119 • Number of events 2
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.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Metabolism and nutrition disorders
Cachexia
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/55
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.00%
0/119
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/55
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.00%
0/119
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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/55
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.00%
0/119
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/55
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.00%
0/119
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.
|
|
Renal and urinary disorders
Renal failure
|
1.8%
1/55 • Number of events 1
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.
|
4.7%
3/64 • Number of events 5
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.
|
4.8%
3/62 • Number of events 4
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.
|
3.4%
4/119 • Number of events 6
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.
|
|
Renal and urinary disorders
Renal failure acute
|
1.8%
1/55 • Number of events 1
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.
|
0.00%
0/64
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.
|
0.00%
0/62
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.
|
0.84%
1/119 • Number of events 1
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.
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/55
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.
|
0.00%
0/64
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.
|
1.6%
1/62 • Number of events 1
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.
|
0.00%
0/119
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
1/55 • Number of events 1
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.
|
1.6%
1/64 • Number of events 1
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.
|
0.00%
0/62
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.
|
1.7%
2/119 • Number of events 2
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.
|
Other adverse events
| Measure |
Clonidine Lauriad® 50µg
n=55 participants at risk
Clonidine Lauriad® 50µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
|
Clonidine Lauriad® 100µg
n=64 participants at risk
Clonidine Lauriad® 100µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks
|
Placebo Lauriad®
n=62 participants at risk
Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks
|
Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled
n=119 participants at risk
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
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
12.7%
7/55 • Number of events 9
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.
|
18.8%
12/64 • Number of events 15
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.
|
12.9%
8/62 • Number of events 9
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.
|
16.0%
19/119 • Number of events 24
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.4%
9/55 • Number of events 11
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.
|
18.8%
12/64 • Number of events 16
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.
|
17.7%
11/62 • Number of events 12
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.
|
17.6%
21/119 • Number of events 27
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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
18.2%
10/55 • Number of events 17
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.
|
18.8%
12/64 • Number of events 19
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.
|
12.9%
8/62 • Number of events 11
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.
|
18.5%
22/119 • Number of events 36
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.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.7%
7/55 • Number of events 10
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.
|
12.5%
8/64 • Number of events 12
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.
|
8.1%
5/62 • Number of events 10
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.
|
12.6%
15/119 • Number of events 22
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.9%
6/55 • Number of events 13
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.
|
9.4%
6/64 • Number of events 11
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.
|
6.5%
4/62 • Number of events 4
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.
|
10.1%
12/119 • Number of events 24
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.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.6%
2/55 • Number of events 2
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.
|
6.2%
4/64 • Number of events 5
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.
|
4.8%
3/62 • Number of events 3
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.
|
5.0%
6/119 • Number of events 7
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.
|
|
Gastrointestinal disorders
Nausea
|
52.7%
29/55 • Number of events 63
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.
|
45.3%
29/64 • Number of events 41
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.
|
71.0%
44/62 • Number of events 82
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.
|
48.7%
58/119 • Number of events 104
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.
|
|
Gastrointestinal disorders
Dysphagia
|
32.7%
18/55 • Number of events 25
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.
|
29.7%
19/64 • Number of events 23
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.
|
46.8%
29/62 • Number of events 40
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.
|
31.1%
37/119 • Number of events 48
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.
|
|
Gastrointestinal disorders
Dry mouth
|
40.0%
22/55 • Number of events 26
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.
|
26.6%
17/64 • Number of events 21
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.
|
27.4%
17/62 • Number of events 22
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.
|
32.8%
39/119 • Number of events 47
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.
|
|
Gastrointestinal disorders
Vomiting
|
25.5%
14/55 • Number of events 26
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.
|
23.4%
15/64 • Number of events 20
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.
|
38.7%
24/62 • Number of events 32
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.
|
24.4%
29/119 • Number of events 46
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.
|
|
Gastrointestinal disorders
Constipation
|
32.7%
18/55 • Number of events 20
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.
|
26.6%
17/64 • Number of events 19
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.
|
25.8%
16/62 • Number of events 16
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.
|
29.4%
35/119 • Number of events 39
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.
|
|
Gastrointestinal disorders
Oral pain
|
29.1%
16/55 • Number of events 40
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.
|
29.7%
19/64 • Number of events 70
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.
|
25.8%
16/62 • Number of events 40
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.
|
29.4%
35/119 • Number of events 110
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.
|
|
Gastrointestinal disorders
Dysgeusia
|
25.5%
14/55 • Number of events 15
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.
|
17.2%
11/64 • Number of events 13
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.
|
19.4%
12/62 • Number of events 12
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.
|
21.0%
25/119 • Number of events 28
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.7%
7/55 • Number of events 15
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.
|
21.9%
14/64 • Number of events 22
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.
|
21.0%
13/62 • Number of events 22
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.
|
17.6%
21/119 • Number of events 37
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.
|
|
Gastrointestinal disorders
Odynophagia
|
12.7%
7/55 • Number of events 11
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.
|
21.9%
14/64 • Number of events 21
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.
|
12.9%
8/62 • Number of events 22
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.
|
17.6%
21/119 • Number of events 32
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.
|
|
Gastrointestinal disorders
Stomatitis
|
10.9%
6/55 • Number of events 15
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.
|
12.5%
8/64 • Number of events 18
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.
|
12.9%
8/62 • Number of events 17
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.
|
11.8%
14/119 • Number of events 33
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
1/55 • Number of events 1
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.
|
9.4%
6/64 • Number of events 6
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.
|
9.7%
6/62 • Number of events 6
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.
|
5.9%
7/119 • Number of events 7
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
2/55 • Number of events 2
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.
|
3.1%
2/64 • Number of events 3
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.
|
8.1%
5/62 • Number of events 5
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.
|
3.4%
4/119 • Number of events 5
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.
|
|
Gastrointestinal disorders
Aptyalism
|
1.8%
1/55 • Number of events 1
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.
|
6.2%
4/64 • Number of events 5
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.
|
4.8%
3/62 • Number of events 4
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.
|
4.2%
5/119 • Number of events 6
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.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
5.5%
3/55 • Number of events 3
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.
|
0.00%
0/64
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.
|
3.2%
2/62 • Number of events 2
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.
|
2.5%
3/119 • Number of events 3
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.
|
|
General disorders
Asthenia
|
16.4%
9/55 • Number of events 12
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.
|
17.2%
11/64 • Number of events 14
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.
|
22.6%
14/62 • Number of events 18
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.
|
16.8%
20/119 • Number of events 26
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.
|
|
General disorders
Mucosal inflammation
|
14.5%
8/55 • Number of events 21
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.
|
17.2%
11/64 • Number of events 19
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.
|
9.7%
6/62 • Number of events 12
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.
|
16.0%
19/119 • Number of events 40
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.
|
|
General disorders
Pyrexia
|
9.1%
5/55 • Number of events 5
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.
|
15.6%
10/64 • Number of events 13
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.
|
4.8%
3/62 • Number of events 3
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.
|
12.6%
15/119 • Number of events 18
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.
|
|
General disorders
Fatigue
|
9.1%
5/55 • Number of events 5
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.
|
7.8%
5/64 • Number of events 6
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.
|
12.9%
8/62 • Number of events 10
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.
|
8.4%
10/119 • Number of events 11
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.
|
|
General disorders
General physical health deterioration
|
5.5%
3/55 • Number of events 4
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.
|
1.6%
1/64 • Number of events 2
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.
|
3.2%
2/62 • Number of events 2
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.
|
3.4%
4/119 • Number of events 6
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.
|
|
General disorders
Pain
|
5.5%
3/55 • Number of events 3
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.
|
3.1%
2/64 • Number of events 3
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.
|
6.5%
4/62 • Number of events 4
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.
|
4.2%
5/119 • Number of events 6
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.
|
|
General disorders
Oedema
|
0.00%
0/55
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.
|
6.2%
4/64 • Number of events 4
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.
|
0.00%
0/62
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.
|
3.4%
4/119 • Number of events 4
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.
|
|
Infections and infestations
Oral candidiasis
|
5.5%
3/55 • Number of events 4
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.
|
15.6%
10/64 • Number of events 11
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.
|
14.5%
9/62 • Number of events 13
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.
|
10.9%
13/119 • Number of events 15
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.
|
|
Infections and infestations
Fungal infection
|
3.6%
2/55 • Number of events 2
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.
|
3.1%
2/64 • Number of events 2
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.
|
11.3%
7/62 • Number of events 7
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.
|
3.4%
4/119 • Number of events 4
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.
|
|
Infections and infestations
Candida infection
|
3.6%
2/55 • Number of events 2
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.
|
3.1%
2/64 • Number of events 2
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.
|
6.5%
4/62 • Number of events 4
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.
|
3.4%
4/119 • Number of events 4
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.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
25.5%
14/55 • Number of events 24
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.
|
34.4%
22/64 • Number of events 45
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.
|
38.7%
24/62 • Number of events 35
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.
|
30.3%
36/119 • Number of events 69
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.
|
|
Investigations
Blood creatinine increased
|
12.7%
7/55 • Number of events 7
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.
|
4.7%
3/64 • Number of events 3
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.
|
11.3%
7/62 • Number of events 7
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.
|
8.4%
10/119 • Number of events 10
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.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
7.3%
4/55 • Number of events 4
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.
|
17.2%
11/64 • Number of events 13
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.
|
27.4%
17/62 • Number of events 19
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.
|
12.6%
15/119 • Number of events 17
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.9%
6/55 • Number of events 8
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.
|
12.5%
8/64 • Number of events 11
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.
|
8.1%
5/62 • Number of events 6
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.
|
11.8%
14/119 • Number of events 19
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.5%
3/55 • Number of events 3
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.
|
1.6%
1/64 • Number of events 1
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.
|
3.2%
2/62 • Number of events 3
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.
|
3.4%
4/119 • Number of events 4
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.
|
|
Nervous system disorders
Headache
|
9.1%
5/55 • Number of events 6
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.
|
3.1%
2/64 • Number of events 2
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.
|
14.5%
9/62 • Number of events 9
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.
|
5.9%
7/119 • Number of events 8
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.
|
|
Nervous system disorders
Dizziness
|
3.6%
2/55 • Number of events 2
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.
|
9.4%
6/64 • Number of events 10
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.
|
3.2%
2/62 • Number of events 3
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.
|
6.7%
8/119 • Number of events 12
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.
|
|
Psychiatric disorders
Anxiety
|
9.1%
5/55 • Number of events 5
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.
|
1.6%
1/64 • Number of events 1
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.
|
4.8%
3/62 • Number of events 4
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.
|
5.0%
6/119 • Number of events 6
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.
|
|
Renal and urinary disorders
Renal failure
|
5.5%
3/55 • Number of events 3
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.
|
3.1%
2/64 • Number of events 2
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.
|
1.6%
1/62 • Number of events 1
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.
|
4.2%
5/119 • Number of events 5
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
3/55 • Number of events 3
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.
|
7.8%
5/64 • Number of events 6
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.
|
12.9%
8/62 • Number of events 8
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.
|
6.7%
8/119 • Number of events 9
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.3%
4/55 • Number of events 4
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.
|
4.7%
3/64 • Number of events 6
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.
|
4.8%
3/62 • Number of events 4
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.
|
5.9%
7/119 • Number of events 10
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.5%
3/55 • Number of events 3
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.
|
4.7%
3/64 • Number of events 3
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.
|
4.8%
3/62 • Number of events 3
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.
|
5.0%
6/119 • Number of events 6
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
20.0%
11/55 • Number of events 27
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.
|
14.1%
9/64 • Number of events 17
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.
|
12.9%
8/62 • Number of events 17
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.
|
16.8%
20/119 • Number of events 44
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.3%
4/55 • Number of events 5
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.
|
6.2%
4/64 • Number of events 4
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.
|
4.8%
3/62 • Number of events 3
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.
|
6.7%
8/119 • Number of events 9
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.
|
|
Vascular disorders
Hypotension
|
5.5%
3/55 • Number of events 4
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.
|
6.2%
4/64 • Number of events 4
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.
|
1.6%
1/62 • Number of events 1
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.
|
5.9%
7/119 • Number of events 8
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60