Trial Outcomes & Findings for Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD) (NCT NCT03242928)
NCT ID: NCT03242928
Last Updated: 2021-10-08
Results Overview
The cocaine consumption was recorded once daily (Yes/No) by the subject using the Timeline Follow-Back (TLFB) cocaine assessment tool during the treatment period. For each patient, the proportion of cocaine use days was calculated by dividing the number of days of cocaine use during the treatment period, i.e. 98 days for completers and number of days between Day 1 and day of last dose in case of premature discontinuation of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Day 1 up to day 98
Results posted on
2021-10-08
Participant Flow
There were 68 patients who received study treatment.
Participant milestones
| Measure |
AFQ056
Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
|
Placebo
Matching tablet of placebo taken orally BID
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
37
|
|
Overall Study
COMPLETED
|
22
|
32
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
AFQ056
Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
|
Placebo
Matching tablet of placebo taken orally BID
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
Baseline Characteristics
Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)
Baseline characteristics by cohort
| Measure |
AFQ056
n=31 Participants
Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
|
Placebo
n=37 Participants
Matching tablet of placebo taken orally BID
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 8.31 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 9.19 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
|
Age, Customized
18 - 65 years
|
31 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
31 participants
n=5 Participants
|
36 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to day 98Population: Pharmacodynamic analysis set (PD): subjects with any available efficacy (PD) data, who received study drug for at least 14 days with no relevant protocol deviation
The cocaine consumption was recorded once daily (Yes/No) by the subject using the Timeline Follow-Back (TLFB) cocaine assessment tool during the treatment period. For each patient, the proportion of cocaine use days was calculated by dividing the number of days of cocaine use during the treatment period, i.e. 98 days for completers and number of days between Day 1 and day of last dose in case of premature discontinuation of study treatment.
Outcome measures
| Measure |
AFQ056
n=29 Participants
Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
|
Placebo
n=36 Participants
Matching tablet of placebo taken orally BID
|
|---|---|---|
|
Proportion of Cocaine Use Days
|
0.122 cocaine use days
Standard Error 0.027
|
0.209 cocaine use days
Standard Error 0.024
|
SECONDARY outcome
Timeframe: Day 1 up to day 98Urine samples were analyzed for the presence of cocaine's metabolite benzoylecgonine (BE) which is the main metabolite of cocaine present in urine. Two urine samples were provided per week to provide a quantitative measure.
Outcome measures
| Measure |
AFQ056
n=29 Participants
Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
|
Placebo
n=36 Participants
Matching tablet of placebo taken orally BID
|
|---|---|---|
|
Proportion of Positive Urine Measurements of Benzoylecgonine (BE)
|
0.666 positive urine samples
Standard Error 0.057
|
0.843 positive urine samples
Standard Error 0.051
|
SECONDARY outcome
Timeframe: Day 1 up to day 98Population: Pharmacodynamic analysis set (PD): subjects with any available efficacy (PD) data, who received study drug for at least 14 days with no relevant protocol deviation
Alcohol consumption was recorded by the subjects using the Timeline Follow-Back (TLFB) alcohol self report. The number of standard drinks were recorded daily. The proportion of days of alcohol consumption during the study treatment period was was compared using an ANCOVA model with treatment as factor and past alcohol consumption as covariate. The past consumption of alcohol was the proportion of alcohol over the 28 days preceding the screening visit, which was assessed retrospectively using the TLFB.
Outcome measures
| Measure |
AFQ056
n=29 Participants
Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
|
Placebo
n=36 Participants
Matching tablet of placebo taken orally BID
|
|---|---|---|
|
Proportion of Days of Alcohol Consumption
|
0.233 alcohol consumption days
Standard Error 0.030
|
0.303 alcohol consumption days
Standard Error 0.026
|
SECONDARY outcome
Timeframe: Day 15 (0h, 2h), Day 29 (0, 2h), Day 57 (0h, 2h), Day 98 (0h,2h)Population: Number of samples available for analysis varied across time points
Plasma samples were collected to assess pharmacokinetics (PK)
Outcome measures
| Measure |
AFQ056
n=29 Participants
Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
|
Placebo
Matching tablet of placebo taken orally BID
|
|---|---|---|
|
AFQ056 Plasma Concentrations
Day 15 0 hour
|
41.2 ng/mL
Standard Deviation 47.4
|
—
|
|
AFQ056 Plasma Concentrations
Day 15 2 hour
|
78.0 ng/mL
Standard Deviation 91.7
|
—
|
|
AFQ056 Plasma Concentrations
Day 29 0 hour
|
83.5 ng/mL
Standard Deviation 116
|
—
|
|
AFQ056 Plasma Concentrations
Day 29 2 hour
|
148 ng/mL
Standard Deviation 131
|
—
|
|
AFQ056 Plasma Concentrations
Day 57 0 hour
|
108 ng/mL
Standard Deviation 153
|
—
|
|
AFQ056 Plasma Concentrations
Day 57 2 hour
|
141 ng/mL
Standard Deviation 153
|
—
|
|
AFQ056 Plasma Concentrations
Day 98 0 hour
|
89.8 ng/mL
Standard Deviation 148
|
—
|
|
AFQ056 Plasma Concentrations
Day 98 2 hour
|
116 ng/mL
Standard Deviation 86.1
|
—
|
Adverse Events
AFQ056
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AFQ056
n=31 participants at risk
Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
|
Placebo
n=37 participants at risk
Matching tablet of placebo taken orally BID
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
Other adverse events
| Measure |
AFQ056
n=31 participants at risk
Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
|
Placebo
n=37 participants at risk
Matching tablet of placebo taken orally BID
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Eye disorders
Blepharospasm
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Eye disorders
Diplopia
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Eye disorders
Photophobia
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Eye disorders
Photopsia
|
9.7%
3/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Eye disorders
Vision blurred
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.7%
3/31 • Number of events 6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
18.9%
7/37 • Number of events 12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
6.5%
2/31 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
2/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
13.5%
5/37 • Number of events 5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
6.5%
2/31 • Number of events 4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
9.7%
3/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
5.4%
2/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Gingival bleeding
|
3.2%
1/31 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
19.4%
6/31 • Number of events 8 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
8.1%
3/37 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Odynophagia
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Paraesthesia oral
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Regurgitation
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
16.2%
6/37 • Number of events 6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
3/31 • Number of events 6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
General disorders
Asthenia
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
General disorders
Discomfort
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
General disorders
Fatigue
|
6.5%
2/31 • Number of events 4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
8.1%
3/37 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
General disorders
Influenza like illness
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
General disorders
Malaise
|
6.5%
2/31 • Number of events 4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
General disorders
Physical deconditioning
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
General disorders
Pyrexia
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
General disorders
Thirst
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Immune system disorders
Seasonal allergy
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
5.4%
2/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Infections and infestations
Hordeolum
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Infections and infestations
Influenza
|
12.9%
4/31 • Number of events 7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
5.4%
2/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Infections and infestations
Laryngitis
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
2/31 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
21.6%
8/37 • Number of events 10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Infections and infestations
Pharyngitis
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Infections and infestations
Rhinitis
|
9.7%
3/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
1/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
2/31 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
5.4%
2/37 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Amylase increased
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
6.5%
2/31 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Blood creatinine abnormal
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Blood triglycerides increased
|
9.7%
3/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
5.4%
2/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Lymphocyte count increased
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Neutrophil count increased
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Platelet count increased
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
Red blood cell count increased
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Investigations
White blood cell count increased
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.9%
4/31 • Number of events 4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
13.5%
5/37 • Number of events 6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Nervous system disorders
Dizziness
|
22.6%
7/31 • Number of events 17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
10.8%
4/37 • Number of events 4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Nervous system disorders
Headache
|
19.4%
6/31 • Number of events 13 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
27.0%
10/37 • Number of events 24 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Nervous system disorders
Muscle contractions involuntary
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Nervous system disorders
Paraesthesia
|
6.5%
2/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Nervous system disorders
Psychomotor hyperactivity
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Nervous system disorders
Resting tremor
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Nervous system disorders
Somnolence
|
12.9%
4/31 • Number of events 4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Anxiety
|
9.7%
3/31 • Number of events 4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
10.8%
4/37 • Number of events 5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Aversion
|
3.2%
1/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Depressed mood
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
5.4%
2/37 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Depressive symptom
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Euphoric mood
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Feeling guilty
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Hallucination
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Hallucination, auditory
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Hallucination, olfactory
|
3.2%
1/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Hallucination, visual
|
6.5%
2/31 • Number of events 3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Ideas of reference
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
5.4%
2/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Illusion
|
6.5%
2/31 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Initial insomnia
|
3.2%
1/31 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Insomnia
|
16.1%
5/31 • Number of events 9 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
5.4%
2/37 • Number of events 11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Irritability
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
5.4%
2/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Nightmare
|
6.5%
2/31 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Paranoia
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Sleep disorder
|
9.7%
3/31 • Number of events 4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Psychiatric disorders
Stress
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Renal and urinary disorders
Nocturia
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal ulcer
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
1/31 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
2.7%
1/37 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
2/31 • Number of events 7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Vascular disorders
Haematoma
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
5.4%
2/37 • Number of events 2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Vascular disorders
Peripheral coldness
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
|
Vascular disorders
Vasospasm
|
3.2%
1/31 • Number of events 1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
0.00%
0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus 14 days post treatment, up to maximum duration of approximately 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER