Trial Outcomes & Findings for Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (NCT NCT02301624)
NCT ID: NCT02301624
Last Updated: 2020-02-05
Results Overview
Treatment-emergent adverse events (TEAEs) are adverse events with onset on or after the first study drug dose in Study ECU-MG-302. Likewise, treatment-emergent serious adverse events (TESAEs) are serious adverse events that onset on or after the first study drug dose in Study ECU-MG-302. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
117 participants
Primary outcome timeframe
Day 1 (after dosing) through End of Study (Week 208)
Results posted on
2020-02-05
Participant Flow
Participants who completed Study ECU-MG-301 (NCT01997229) were eligible to participate in Study ECU-MG-302.
Participant milestones
| Measure |
Eculizumab/Eculizumab
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-MG-301 were administered eculizumab (4 vials/1200 milligrams \[mg\]) on Day 1 and Week 2 and placebo (4 vials/0 mg) at Weeks 1 and 3.
Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
Placebo/Eculizumab
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-MG-301 were administered eculizumab/placebo (3 vials/900 mg, plus 1 vial/0 mg, respectively) on Day 1 and Weeks 1 through 3.
Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
|---|---|---|
|
Blind Induction Phase
STARTED
|
56
|
61
|
|
Blind Induction Phase
Received at Least 1 Dose of Study Drug
|
56
|
61
|
|
Blind Induction Phase
COMPLETED
|
55
|
61
|
|
Blind Induction Phase
NOT COMPLETED
|
1
|
0
|
|
Open-label Maintenance Phase
STARTED
|
55
|
61
|
|
Open-label Maintenance Phase
Received at Least 1 Dose of Study Drug
|
55
|
61
|
|
Open-label Maintenance Phase
COMPLETED
|
43
|
44
|
|
Open-label Maintenance Phase
NOT COMPLETED
|
12
|
17
|
Reasons for withdrawal
| Measure |
Eculizumab/Eculizumab
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-MG-301 were administered eculizumab (4 vials/1200 milligrams \[mg\]) on Day 1 and Week 2 and placebo (4 vials/0 mg) at Weeks 1 and 3.
Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
Placebo/Eculizumab
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-MG-301 were administered eculizumab/placebo (3 vials/900 mg, plus 1 vial/0 mg, respectively) on Day 1 and Weeks 1 through 3.
Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
|---|---|---|
|
Blind Induction Phase
Withdrawal by Subject
|
1
|
0
|
|
Open-label Maintenance Phase
Withdrawal by Subject
|
4
|
8
|
|
Open-label Maintenance Phase
Adverse Event
|
2
|
5
|
|
Open-label Maintenance Phase
Physician Decision
|
3
|
3
|
|
Open-label Maintenance Phase
Death
|
2
|
1
|
|
Open-label Maintenance Phase
Participant felt no change in condition
|
1
|
0
|
Baseline Characteristics
Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis
Baseline characteristics by cohort
| Measure |
Eculizumab/Eculizumab
n=56 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-MG-301 were administered eculizumab (4 vials/1200 mg) on Day 1 and Week 2 and placebo (4 vials/0 mg) at Weeks 1 and 3.
Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
Placebo/Eculizumab
n=61 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-MG-301 were administered eculizumab/placebo (3 vials/900 mg, plus 1 vial/0 mg, respectively) on Day 1 and Weeks 1 through 3.
Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 15.52 • n=99 Participants
|
47.5 years
STANDARD_DEVIATION 17.85 • n=107 Participants
|
47.4 years
STANDARD_DEVIATION 16.70 • n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 (after dosing) through End of Study (Week 208)Population: All participants who received at least 1 dose of eculizumab in this extension study.
Treatment-emergent adverse events (TEAEs) are adverse events with onset on or after the first study drug dose in Study ECU-MG-302. Likewise, treatment-emergent serious adverse events (TESAEs) are serious adverse events that onset on or after the first study drug dose in Study ECU-MG-302. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Eculizumab/Eculizumab
n=56 Participants
After receiving blinded treatment with eculizumab in Study ECU-MG-301 for 26 weeks, all participants received blinded study drug weekly for 4 weeks, then received open-label eculizumab 1200 mg every 2 weeks for up to 4 years in this extension study.
|
Placebo/Eculizumab
n=61 Participants
After receiving blinded treatment with placebo in Study ECU-MG-301 for 26 weeks, all participants received blinded study drug weekly for 4 weeks, then received open-label eculizumab 1200 mg every 2 weeks for up to 4 years in this extension study.
|
|---|---|---|
|
Count Of Participants With Treatment-Emergent Adverse Events
TEAEs
|
55 Participants
|
59 Participants
|
|
Count Of Participants With Treatment-Emergent Adverse Events
TEAEs leading to withdrawal
|
3 Participants
|
5 Participants
|
|
Count Of Participants With Treatment-Emergent Adverse Events
TESAEs
|
30 Participants
|
30 Participants
|
|
Count Of Participants With Treatment-Emergent Adverse Events
TESAEs leading to withdrawal
|
3 Participants
|
4 Participants
|
|
Count Of Participants With Treatment-Emergent Adverse Events
Deaths
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 130Population: All participants who received at least 1 dose of eculizumab in this extension study and had an MG-ADL efficacy assessment after study drug infusion at the specified time points.
The MG-ADL scale is a validated 8-item patient-reported outcome measure. Participants assessed their functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb impairment (2 items). These 8 items were not weighted and were individually graded from 0 (normal) to 3 (most severe), providing a total MG-ADL score ranging from 0 to 24 points. A reduction in score indicates improvement in condition. Baseline was defined as the last available assessment prior to treatment (first study drug infusion) with eculizumab in Study ECU-MG-302. Change from Baseline in MG-ADL total score at Week 4 (blind induction phase) and at Week 130 (open-label eculizumab phase) are presented.
Outcome measures
| Measure |
Eculizumab/Eculizumab
n=55 Participants
After receiving blinded treatment with eculizumab in Study ECU-MG-301 for 26 weeks, all participants received blinded study drug weekly for 4 weeks, then received open-label eculizumab 1200 mg every 2 weeks for up to 4 years in this extension study.
|
Placebo/Eculizumab
n=61 Participants
After receiving blinded treatment with placebo in Study ECU-MG-301 for 26 weeks, all participants received blinded study drug weekly for 4 weeks, then received open-label eculizumab 1200 mg every 2 weeks for up to 4 years in this extension study.
|
|---|---|---|
|
Change From Baseline In Myasthenia Gravis Activities Of Daily Living Profile (MG-ADL) Total Score At Week 4 And Week 130
Change from Baseline At Week 4 (Blind Induction)
|
-0.2 units on a scale
Standard Deviation 1.77
|
-2.4 units on a scale
Standard Deviation 3.04
|
|
Change From Baseline In Myasthenia Gravis Activities Of Daily Living Profile (MG-ADL) Total Score At Week 4 And Week 130
Change from Baseline at Week 130 (Open-label)
|
-0.7 units on a scale
Standard Deviation 4.19
|
-3.9 units on a scale
Standard Deviation 3.68
|
Adverse Events
Eculizumab/Eculizumab
Serious events: 30 serious events
Other events: 54 other events
Deaths: 2 deaths
Placebo/Eculizumab
Serious events: 30 serious events
Other events: 59 other events
Deaths: 1 deaths
Eculizumab (Combined Total)
Serious events: 60 serious events
Other events: 113 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Eculizumab/Eculizumab
n=56 participants at risk
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-MG-301 were administered eculizumab (4 vials/1200 mg) on Day 1 and Week 2 and placebo (4 vials/0 mg) at Weeks 1 and 3.
Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
Placebo/Eculizumab
n=61 participants at risk
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-MG-301 were administered eculizumab/placebo (3 vials/900 mg, plus 1 vial/0 mg, respectively) on Day 1 and Weeks 1 through 3.
Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
Eculizumab (Combined Total)
n=117 participants at risk
All participants who received at least 1 dose of eculizumab in the extension study. Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.9%
3/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Lupus vasculitis
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Aspergillus infection
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.7%
2/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bursitis infective staphylococcal
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Colonic abscess
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related sepsis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.7%
2/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Localised infection
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.7%
2/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis meningococcal
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Periorbital cellulitis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.4%
4/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pseudomonal sepsis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pseudomonas infection
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rectal abscess
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.7%
2/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.7%
2/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Wound infection
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.7%
2/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Central obesity
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Obesity
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.7%
2/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/18 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.0%
1/20 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Myasthenia gravis
|
12.5%
7/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
14.8%
9/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
13.7%
16/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Myasthenia gravis crisis
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.4%
4/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.7%
2/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/38 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
2.6%
1/38 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.6%
1/38 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.9%
3/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.7%
2/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.85%
1/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Eculizumab/Eculizumab
n=56 participants at risk
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-MG-301 were administered eculizumab (4 vials/1200 mg) on Day 1 and Week 2 and placebo (4 vials/0 mg) at Weeks 1 and 3.
Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
Placebo/Eculizumab
n=61 participants at risk
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-MG-301 were administered eculizumab/placebo (3 vials/900 mg, plus 1 vial/0 mg, respectively) on Day 1 and Weeks 1 through 3.
Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
Eculizumab (Combined Total)
n=117 participants at risk
All participants who received at least 1 dose of eculizumab in the extension study. Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.
Eculizumab 1200 mg was administered for up to 4 years in this extension study.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.8%
6/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
7.7%
9/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
35.7%
20/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
39.3%
24/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
37.6%
44/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.9%
3/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.0%
7/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Myasthenia gravis
|
21.4%
12/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.2%
5/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
14.5%
17/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.8%
8/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
13.1%
8/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.4%
11/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
12.5%
7/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
7.7%
9/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.4%
4/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
7.9%
3/38 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.8%
3/79 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.3%
5/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
12/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
16.4%
10/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
18.8%
22/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
14.8%
9/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
10.3%
12/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.4%
4/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.3%
5/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.9%
3/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.8%
8/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.9%
3/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.4%
4/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
10.7%
6/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.9%
5/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.9%
3/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.8%
8/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.3%
5/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.3%
5/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.3%
5/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.0%
7/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Cataract
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.2%
5/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
7.7%
9/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Dry eye
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.4%
4/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.8%
6/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.5%
10/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.3%
5/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.8%
6/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.8%
8/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.2%
5/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.0%
7/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.8%
15/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
23.0%
14/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
24.8%
29/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.1%
9/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
21.3%
13/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
18.8%
22/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Tooth disorder
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.2%
5/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.8%
8/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
11.5%
7/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.5%
10/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
14.3%
8/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
11.5%
7/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
12.8%
15/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.9%
3/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.0%
7/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.9%
3/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.0%
7/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.3%
5/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
8.9%
5/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
13.1%
8/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
11.1%
13/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
11.5%
7/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.5%
10/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
10.7%
6/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
11.5%
7/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
11.1%
13/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.8%
8/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
10.7%
6/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.2%
5/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.4%
11/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.8%
6/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.5%
10/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.4%
4/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
19.6%
11/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
16.4%
10/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
17.9%
21/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
35.7%
20/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
36.1%
22/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
35.9%
42/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.9%
3/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.8%
6/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.5%
10/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.4%
4/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
12.5%
7/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.4%
11/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
1.8%
1/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.3%
5/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
21.4%
12/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
24.6%
15/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
23.1%
27/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
17.9%
10/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
13.1%
8/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
15.4%
18/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
7/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
8.2%
5/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
10.3%
12/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
8/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.8%
6/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
12.0%
14/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.1%
4/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
11.5%
7/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.4%
11/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.3%
5/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.6%
2/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
5.1%
6/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
2.6%
3/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.4%
4/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
1.6%
1/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.4%
4/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
3.3%
2/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
4.3%
5/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.6%
11/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
19.7%
12/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
19.7%
23/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
5/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
11.5%
7/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
10.3%
12/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.9%
5/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.8%
6/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
9.4%
11/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.4%
3/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.0%
7/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.9%
5/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
11.5%
7/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
10.3%
12/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.9%
5/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
6.6%
4/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
7.7%
9/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.1%
9/56 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
13.1%
8/61 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
14.5%
17/117 • Day 1 after dosing of study drug through Week 208.
All eligible enrolled participants who received at least 1 dose of study drug.
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor can review results communications at least 60 days prior to public release. Within 30 days of receipt, Sponsor shall advise of any information which is Confidential Information (other than Study Data) or which may impair the availability of patent protection for Inventions. Sponsor can require removal of specifically identified Confidential Information (other than Study Data) and/or delay the communication an additional 60 days to enable Sponsor to seek patent protection for Inventions.
- Publication restrictions are in place
Restriction type: OTHER