Trial Outcomes & Findings for Safety and Efficacy of RHH646 for Knee Osteoarthritis (NCT NCT05816395)
NCT ID: NCT05816395
Last Updated: 2026-03-31
Results Overview
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in the volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
Baseline, Week 52
Results posted on
2026-03-31
Participant Flow
Participants took part in 10 investigative sites in 5 countries.
The study consisted of a screening period up to 6 weeks.
Participant milestones
| Measure |
RHH646 75 mg
RHH646 was administered orally once per day for a year.
|
Placebo
Matching Placebo was administered orally once per day for a year.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
RHH646 75 mg
RHH646 was administered orally once per day for a year.
|
Placebo
Matching Placebo was administered orally once per day for a year.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Deviation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Safety and Efficacy of RHH646 for Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
RHH646 75 mg
n=41 Participants
RHH646 was administered orally once per day for a year.
|
Placebo
n=41 Participants
Matching Placebo was administered orally once per day for a year.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.12 years
STANDARD_DEVIATION 6.779 • n=4 Participants
|
62.20 years
STANDARD_DEVIATION 7.862 • n=28 Participants
|
62.16 years
STANDARD_DEVIATION 7.295 • n=10 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=4 Participants
|
31 Participants
n=28 Participants
|
51 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=4 Participants
|
10 Participants
n=28 Participants
|
31 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=4 Participants
|
2 Participants
n=28 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=4 Participants
|
38 Participants
n=28 Participants
|
76 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: The Safety Analysis Set included all participants who received any study treatment and had an available value for the outcome measure as aligned with protocol.
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in the volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.
Outcome measures
| Measure |
RHH646 75 mg
n=37 Participants
RHH646 was administered orally once per day for a year.
|
Placebo
n=34 Participants
Matching Placebo was administered orally once per day for a year.
|
|---|---|---|
|
Change From Baseline in Cartilage Volume in the Index Region of the Target Knee by MRI
|
94.6 µL
Standard Error 36.67
|
9.3 µL
Standard Error 38.15
|
PRIMARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.Population: The Safety Analysis Set included all participants who received any study treatment.
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
Outcome measures
| Measure |
RHH646 75 mg
n=41 Participants
RHH646 was administered orally once per day for a year.
|
Placebo
n=41 Participants
Matching Placebo was administered orally once per day for a year.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events
|
34 Participants
|
35 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious Adverse Events
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (4 hours post dose), Week 4 (pre dose)Population: The PK Analysis Set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received any dose of RHH646 and with no protocol deviations that impact PK data.
RHH646 concentration was determined by a validated LC-MS/MS method; the anticipated Lower Limit of Quantification (LLOQ) was 2 ng/mL. RHH646 concentrations below the lower limit of quantification (LLOQ) were treated as "zero" .
Outcome measures
| Measure |
RHH646 75 mg
n=40 Participants
RHH646 was administered orally once per day for a year.
|
Placebo
Matching Placebo was administered orally once per day for a year.
|
|---|---|---|
|
Pharmacokinetic (PK) Parameter: RHH646 Plasma Concentrations
Week 4 (pre dose)
|
726 ng/mL
Standard Deviation 239
|
—
|
|
Pharmacokinetic (PK) Parameter: RHH646 Plasma Concentrations
Baseline (4 hours post dose)
|
541 ng/mL
Standard Deviation 186
|
—
|
Adverse Events
RHH646 75 mg
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Total
Serious events: 4 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RHH646 75 mg
n=41 participants at risk
RHH646 was administered orally once per day for a year.
|
Placebo
n=41 participants at risk
Matching Placebo was administered orally once per day for a year.
|
Total
n=82 participants at risk
Total
|
|---|---|---|---|
|
Infections and infestations
Erysipelas
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Postoperative wound infection
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
Other adverse events
| Measure |
RHH646 75 mg
n=41 participants at risk
RHH646 was administered orally once per day for a year.
|
Placebo
n=41 participants at risk
Matching Placebo was administered orally once per day for a year.
|
Total
n=82 participants at risk
Total
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Cardiac disorders
Cardiac failure
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Endocrine disorders
Goitre
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Eye disorders
Corneal disorder
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Colitis microscopic
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Large intestine polyp
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
General disorders and administration site conditions
Chest discomfort
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
General disorders and administration site conditions
Influenza like illness
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
4/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
General disorders and administration site conditions
Oedema peripheral
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
General disorders and administration site conditions
Peripheral swelling
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
General disorders and administration site conditions
Pyrexia
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
COVID-19
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
11.0%
9/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Gastroenteritis viral
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
3.7%
3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Herpes simplex
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Influenza
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
6.1%
5/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Localised infection
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
7.3%
6/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Otitis externa
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Rectal abscess
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
7.3%
6/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Urinary tract infection
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
7.3%
6/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
14.6%
6/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
8.5%
7/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
4/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Skin injury
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Injury, poisoning and procedural complications
Spinal cord injury lumbar
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Investigations
Blood pressure increased
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Investigations
Cardiac murmur
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Investigations
Weight increased
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
3.7%
3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.1%
7/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
17.1%
7/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
17.1%
14/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
7.3%
6/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
3.7%
3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of cervix uteri
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Nervous system disorders
Dizziness
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
3.7%
3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Nervous system disorders
Headache
|
14.6%
6/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
19.5%
8/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
17.1%
14/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Nervous system disorders
Phantom limb syndrome
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Renal and urinary disorders
Bladder cyst
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
3.7%
3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
|
Vascular disorders
Hypertension
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.
|
4.9%
4/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 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