Trial Outcomes & Findings for Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia. (NCT NCT01753310)
NCT ID: NCT01753310
Last Updated: 2019-08-07
Results Overview
The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
134 participants
Primary outcome timeframe
4 weeks post-treatment
Results posted on
2019-08-07
Participant Flow
First subject enrolled: 7 January 2013; last subject completed: 9 January 2015. 46 investigational sites in the United States of America were planned, 43 sites were initiated and 38 sites enrolled adult subjects with cervical dystonia (CD).
150 subjects were screened; 16 subjects failed screening. 134 subjects were enrolled (signed informed consent) and were randomised with a 2:1 ratio of Dysport®:placebo. Randomisation was also stratified for subjects who were Botulinum toxin type A (BoNT-A) treatment naive or non-naive at baseline.
Participant milestones
| Measure |
Dysport®
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
45
|
|
Overall Study
COMPLETED
|
57
|
21
|
|
Overall Study
NOT COMPLETED
|
32
|
24
|
Reasons for withdrawal
| Measure |
Dysport®
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
Overall Study
Entered into open label extension study
|
25
|
22
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Subject decision
|
2
|
2
|
|
Overall Study
Sponsor decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
Baseline characteristics by cohort
| Measure |
Dysport®
n=89 Participants
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=45 Participants
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
Total Title
n=134 Participants
|
|---|---|---|---|
|
Age, Customized
18-24 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Age, Customized
25-34 years
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Age, Customized
35-44 years
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Age, Customized
45-54 years
|
26 participants
n=99 Participants
|
14 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Age, Customized
55-64 years
|
26 participants
n=99 Participants
|
12 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Age, Customized
65-74 years
|
22 participants
n=99 Participants
|
11 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Age, Customized
>75 years
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-treatmentPopulation: The modified ITT population consisted of all randomised subjects with both a baseline and a Week 4 post-treatment TWSTRS total score assessment.
The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.
Outcome measures
| Measure |
Dysport®
n=84 Participants
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=45 Participants
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
Baseline (Day 1) Pre-treatment
|
42.5 units on a scale
Standard Deviation 10.40
|
42.4 units on a scale
Standard Deviation 10.63
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
Week 4 Post-treatment
|
31.7 units on a scale
Standard Deviation 15.29
|
39.9 units on a scale
Standard Deviation 12.46
|
SECONDARY outcome
Timeframe: 2 weeks post-treatmentPopulation: The ITT population consisted of all randomised subjects.
The change from baseline in the TWSTRS total score at Week 2 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.
Outcome measures
| Measure |
Dysport®
n=89 Participants
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=45 Participants
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
Change From Baseline in TWSTRS Total Score at Week 2.
Baseline (Day 1) pre-treatment
|
42.1 units on a scale
Standard Deviation 10.77
|
42.4 units on a scale
Standard Deviation 10.63
|
|
Change From Baseline in TWSTRS Total Score at Week 2.
Week 2 post-treatment
|
34.5 units on a scale
Standard Deviation 14.54
|
39.8 units on a scale
Standard Deviation 12.72
|
SECONDARY outcome
Timeframe: 2 weeks post-treatmentPopulation: The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 4 subjects (3 from the Dysport® arm and 1 from the Placebo arm) had missing values for CGIC.
The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.
Outcome measures
| Measure |
Dysport®
n=86 Participants
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=44 Participants
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.
|
1.2 units on a scale
Standard Deviation 1.32
|
-0.0 units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 2 weeks post-treatmentPopulation: The ITT population consisted of all randomised subjects.
Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as (\[Week 2 score - baseline score\]/baseline score) \* 100.
Outcome measures
| Measure |
Dysport®
n=89 Participants
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=45 Participants
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
TWSTRS Responders at Week 2.
|
27.9 percentage of participants
Interval 18.8 to 38.6
|
11.4 percentage of participants
Interval 3.8 to 24.6
|
SECONDARY outcome
Timeframe: 4 weeks post-treatmentPopulation: The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 3 subjects (all from the Dysport® arm) had missing values for CGIC.
The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.
Outcome measures
| Measure |
Dysport®
n=86 Participants
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=45 Participants
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
Change From Baseline in CGIC in CD at Week 4.
|
1.2 units on a scale
Standard Deviation 1.50
|
0.1 units on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: 4 weeks post-treatmentPopulation: The ITT population consisted of all randomised subjects.
Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as (\[Week 4 score - baseline score\]/baseline score) \* 100.
Outcome measures
| Measure |
Dysport®
n=89 Participants
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=45 Participants
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
TWSTRS Responders at Week 4.
|
41.9 percentage of participants
Interval 31.3 to 53.0
|
11.1 percentage of participants
Interval 3.7 to 24.1
|
SECONDARY outcome
Timeframe: 4 weeks post-treatmentPopulation: The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (7 from the Dysport® arm and 1 from the Placebo arm) had missing values for CDIP-58.
The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening.
Outcome measures
| Measure |
Dysport®
n=82 Participants
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=44 Participants
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.
|
-8.5 units on a scale
Standard Deviation 14.26
|
-4.7 units on a scale
Standard Deviation 16.18
|
SECONDARY outcome
Timeframe: 2 weeks post-treatmentPopulation: The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (6 from the Dysport® arm and 2 from the Placebo arm) had missing values for CDIP-58.
The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect.
Outcome measures
| Measure |
Dysport®
n=83 Participants
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=43 Participants
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
Change From Baseline in CDIP-58 Total Score at Week 2.
|
-5.8 units on a scale
Standard Deviation 13.96
|
-4.3 units on a scale
Standard Deviation 14.49
|
Adverse Events
Dysport®
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dysport®
n=88 participants at risk
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=45 participants at risk
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/88 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
2.2%
1/45 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
Other adverse events
| Measure |
Dysport®
n=88 participants at risk
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
|
Placebo
n=45 participants at risk
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
2/88 • Number of events 2 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
General disorders
Pain
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
8/88 • Number of events 8 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.0%
7/88 • Number of events 7 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Gastrointestinal disorders
Dysphagia
|
8.0%
7/88 • Number of events 7 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Infections and infestations
Sinusitis
|
3.4%
3/88 • Number of events 3 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Infections and infestations
Bronchitis
|
2.3%
2/88 • Number of events 2 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Nervous system disorders
Burning sensation
|
2.3%
2/88 • Number of events 2 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Nervous system disorders
Presyncope
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Surgical and medical procedures
Endodontic procedure
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/88 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
2.2%
1/45 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/88 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
2.2%
1/45 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Eye disorders
Vision blurred
|
2.3%
2/88 • Number of events 2 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Eye disorders
Dry eye
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Nervous system disorders
Hypoaesthesia
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Investigations
Blood triglycerides increased
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
2.2%
1/45 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Nervous system disorders
Headache
|
5.7%
5/88 • Number of events 5 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Psychiatric disorders
Depression
|
2.3%
2/88 • Number of events 2 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
2.2%
1/45 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/88 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
4.4%
2/45 • Number of events 2 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/88 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
2.2%
1/45 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/88 • Number of events 2 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
4.4%
2/45 • Number of events 2 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Injury, poisoning and procedural complications
Post injection phenomenon
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/88 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
2.2%
1/45 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/88 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
2.2%
1/45 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/88 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
2.2%
1/45 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
General disorders
Fatigue
|
2.3%
2/88 • Number of events 2 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Investigations
Blood bilirubin increased
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/88 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
2.2%
1/45 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Eye disorders
Visual Impairment
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Infections and infestations
Ear infection
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
General disorders
Gait disturbance
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Investigations
Blood potassium decreased
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Investigations
Blood cholesterol increased
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Nervous system disorders
Tension headache
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
1.1%
1/88 • Number of events 1 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
0.00%
0/45 • Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place