Trial Outcomes & Findings for A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis (NCT NCT01085097)
NCT ID: NCT01085097
Last Updated: 2022-03-09
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Baseline up to Week 28
Results posted on
2022-03-09
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received 2 capsules of placebo matched to laquinimod orally once daily (QD) for 24 weeks, mycophenolate mofetil (MMF) 500 milligrams (mg) tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and methylprednisolone (MP) 500 mg/day intravenously(IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 0.5 mg
Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 1 mg
Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
15
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
15
|
16
|
15
|
|
Overall Study
COMPLETED
|
13
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 2 capsules of placebo matched to laquinimod orally once daily (QD) for 24 weeks, mycophenolate mofetil (MMF) 500 milligrams (mg) tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and methylprednisolone (MP) 500 mg/day intravenously(IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 0.5 mg
Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 1 mg
Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
|
Overall Study
Treatment failure
|
2
|
0
|
0
|
Baseline Characteristics
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 0.5 mg
n=16 Participants
Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 1 mg
n=15 Participants
Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
32.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
33.8 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 28Population: Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 0.5 mg
n=16 Participants
Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 1 mg
n=15 Participants
Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
14 participants
|
15 participants
|
15 participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Modified intent-to-treat (mITT) analysis set included all randomized participants, excluding observations after treatment failure.
Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 0.5 mg
n=16 Participants
Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 1 mg
n=15 Participants
Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
|---|---|---|---|
|
Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
|
12.1 percent change
Standard Deviation 20.17
|
18.0 percent change
Standard Deviation 30.65
|
24.3 percent change
Standard Deviation 28.84
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Laquinimod 0.5 mg
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Laquinimod 1 mg
Serious events: 4 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=15 participants at risk
Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 0.5 mg
n=16 participants at risk
Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 1 mg
n=15 participants at risk
Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
General disorders
Generalised Oedema
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Herpes Zoster
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
Other adverse events
| Measure |
Placebo
n=15 participants at risk
Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 0.5 mg
n=16 participants at risk
Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
Laquinimod 1 mg
n=15 participants at risk
Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Increased Upper Airway Secretion
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Ear and labyrinth disorders
Middle Ear Effusion
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Endocrine disorders
Cushing's Syndrome
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
12.5%
2/16 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Eye disorders
Dry Eye
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Eye disorders
Visual Impairment
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
12.5%
2/16 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
12.5%
2/16 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
20.0%
3/15 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Gingival Recession
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
12.5%
2/16 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
12.5%
2/16 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
General disorders
Asthenia
|
13.3%
2/15 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
General disorders
Chills
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
General disorders
Fatigue
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
General disorders
Generalised Oedema
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
General disorders
Oedema
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
General disorders
Oedema Peripheral
|
26.7%
4/15 • Number of events 6 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
12.5%
2/16 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
General disorders
Pyrexia
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
12.5%
2/16 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Cystitis
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
13.3%
2/15 • Number of events 5 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Folliculitis
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Herpes Zoster
|
13.3%
2/15 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
20.0%
3/15 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Oral Candidiasis
|
6.7%
1/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Sinusitis
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
12.5%
2/16 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Subcutaneous Abscess
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Tinea Pedis
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
20.0%
3/15 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
25.0%
4/16 • Number of events 5 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
6.7%
1/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Infections and infestations
Varicella
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Investigations
Bacterial Test Positive
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Investigations
Blood Albumin Increased
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Investigations
Blood Urea Increased
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Investigations
Weight Decreased
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
18.8%
3/16 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Investigations
Weight Increased
|
20.0%
3/15 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
18.8%
3/16 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Metabolism and nutrition disorders
Macroamylasaemia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
12.5%
2/16 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint Lock
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
20.0%
3/15 • Number of events 4 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
18.8%
3/16 • Number of events 5 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.7%
1/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
12.5%
2/16 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
6.7%
1/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Nervous system disorders
Ageusia
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
25.0%
4/16 • Number of events 6 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 4 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Psychiatric disorders
Affect Lability
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
18.8%
3/16 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Renal and urinary disorders
Dysuria
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
13.3%
2/15 • Number of events 3 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Papule
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • Number of events 2 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Surgical and medical procedures
Vasectomy
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Vascular disorders
Hot Flush
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
0.00%
0/16 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 28
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D, Inc.
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER