Trial Outcomes & Findings for A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis (NCT NCT00979654)
NCT ID: NCT00979654
Last Updated: 2016-10-27
Results Overview
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
From start of study drug administration until week 182
Results posted on
2016-10-27
Participant Flow
A total of 118 participants were Screened out of which 15 participants did not meet eligibility criteria and were considered screen failures, and 103 participants were entered into the study.
Participant milestones
| Measure |
MEDI-545
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
|
|---|---|
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Overall Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
MEDI-545
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
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Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
22
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Adverse Event of Diverticulitis
|
1
|
|
Overall Study
Per Principal Investigator's Discretion
|
1
|
|
Overall Study
Patient Wanted to Pursue Other Treatment
|
1
|
|
Overall Study
Serious Adverse Event
|
1
|
|
Overall Study
Unfavorable Risk-Benefit Analysis
|
1
|
Baseline Characteristics
A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis
Baseline characteristics by cohort
| Measure |
MEDI-545
n=103 Participants
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
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Age, Continuous
|
48.2 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Age, Customized
< 40
|
21 Participants
n=5 Participants
|
|
Age, Customized
40 - <65
|
78 Participants
n=5 Participants
|
|
Age, Customized
>= 65
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration until week 182Population: Safety Population included all participants who received at least one dose of investigational product.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)
n=103 Participants
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
101 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
27 participants
|
SECONDARY outcome
Timeframe: Pre-infusion and End of Infusion on Day 1Population: The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, "N" is number of participants analyzed for this outcome measure.
The Cmax is the maximum observed plasma concentration of sifalimumab.
Outcome measures
| Measure |
Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)
n=94 Participants
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
|
Maximum Observed Serum Concentration (Cmax) for Sifalimumab
|
225.569 microgram per milliliter (mcg/mL)
Standard Deviation 78.842
|
SECONDARY outcome
Timeframe: Pre-infusion and End of Infusion on Day 1Population: The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, "N" is number of participants analyzed for this outcome measure.
The Tmax is the time to reach maximum observed plasma concentration of sifalimumab.
Outcome measures
| Measure |
Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)
n=94 Participants
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab
|
0.049 days
Interval 0.04 to 0.13
|
SECONDARY outcome
Timeframe: Pre-infusion and End of Infusion on Day 1Population: The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, "N" is number of participants analyzed for this outcome measure.
The Tlast is the time to last quantifiable plasma concentration (Tlast) of sifalimumab.
Outcome measures
| Measure |
Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)
n=99 Participants
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
|
Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab
|
14.413 days
Standard Deviation 1.693
|
SECONDARY outcome
Timeframe: Pre-infusion and End of Infusion on Day 1Population: The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, "N" is number of participants analyzed for this outcome measure.
The Ctrough is the minimum observed serum concentration of sifalimumab.
Outcome measures
| Measure |
Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)
n=99 Participants
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
|
Minimum Observed Serum Concentration (Ctrough) of Sifalimumab
|
65.009 mcg/mL
Standard Deviation 30.516
|
SECONDARY outcome
Timeframe: Pre-infusion and End of Infusion on Day 1Population: The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, "N" is number of participants analyzed for this outcome measure.
The AUCtau is the area under the serum concentration-time curve over the dosing interval of sifalimumab.
Outcome measures
| Measure |
Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)
n=93 Participants
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
|
Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab
|
2084.180 microgram.day per milliliter(mcg*day/mL)
Standard Deviation 665.882
|
SECONDARY outcome
Timeframe: Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168Population: The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, "N" is number of participants analyzed for this outcome measure.
The Ctrough is the minimum observed serum concentration at steady state of sifalimumab.
Outcome measures
| Measure |
Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)
n=87 Participants
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
|
Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab
|
78.731 mcg/mL
Standard Deviation 53.942
|
SECONDARY outcome
Timeframe: Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168Population: The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, "N" is number of participants analyzed for this outcome measure.
The Ctrough is the minimum observed serum concentration of sifalimumab. Accumulation Index is calculated as Ctrough value at steady state divided by Ctrough value after first dose.
Outcome measures
| Measure |
Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)
n=84 Participants
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
|
|---|---|
|
Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab
|
1.217 ratio
Standard Deviation 0.808
|
SECONDARY outcome
Timeframe: Day 1 and Week 12, 24, 52, 104, 156 and 168Population: Safety Population included all participants who received at least one dose of investigational product.
Participants tested for immunogenicity to Sifalimumab (MEDI-545) from Day 1 to the end of study.
Outcome measures
| Measure |
Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)
n=103 Participants
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
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Number of Participants With Positive Anti-Drug Antibody
Day 1
|
5 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody
Week 12
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody
Week 24
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody
Week 52
|
1 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody
Week 104
|
4 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody
Week 156
|
1 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody
Week 168
|
4 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody
Any Day Post Baseline
|
9 Participants
|
Adverse Events
MEDI-545
Serious events: 27 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MEDI-545
n=103 participants at risk
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
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|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
2/103 • Number of events 2 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Cardiac disorders
Cardiac tamponade
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Cardiac disorders
Myocardial infarction
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Cardiac disorders
Pericardial effusion
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
General disorders
Mucosal inflammation
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
General disorders
Non-cardiac chest pain
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Abscess limb
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Bone abscess
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Cellulitis
|
2.9%
3/103 • Number of events 3 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Diverticulitis
|
1.9%
2/103 • Number of events 2 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Enteritis infectious
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Herpes simplex meningitis
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Intervertebral discitis
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Osteomyelitis
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Pneumonia
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/103 • Number of events 2 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.9%
3/103 • Number of events 3 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Psychiatric disorders
Bipolar disorder
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Psychiatric disorders
Depression
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Psychiatric disorders
Suicidal ideation
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Renal and urinary disorders
Renal failure acute
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Vascular disorders
Deep vein thrombosis
|
0.97%
1/103 • Number of events 1 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
Other adverse events
| Measure |
MEDI-545
n=103 participants at risk
All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
6/103 • Number of events 8 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.5%
16/103 • Number of events 24 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.8%
6/103 • Number of events 6 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
19.4%
20/103 • Number of events 28 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
11/103 • Number of events 17 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
General disorders
Fatigue
|
7.8%
8/103 • Number of events 9 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Immune system disorders
Seasonal allergy
|
6.8%
7/103 • Number of events 7 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Bronchitis
|
22.3%
23/103 • Number of events 36 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
6.8%
7/103 • Number of events 7 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Gastroenteritis viral
|
5.8%
6/103 • Number of events 10 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Herpes zoster
|
7.8%
8/103 • Number of events 8 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Influenza
|
6.8%
7/103 • Number of events 10 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
21.4%
22/103 • Number of events 36 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Sinusitis
|
17.5%
18/103 • Number of events 38 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
38.8%
40/103 • Number of events 65 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Urinary tract infection
|
29.1%
30/103 • Number of events 62 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.8%
6/103 • Number of events 13 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.7%
9/103 • Number of events 12 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
6/103 • Number of events 8 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.8%
8/103 • Number of events 13 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.4%
22/103 • Number of events 26 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.7%
12/103 • Number of events 12 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.8%
6/103 • Number of events 6 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.8%
8/103 • Number of events 8 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.8%
6/103 • Number of events 6 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
6.8%
7/103 • Number of events 9 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Dizziness
|
9.7%
10/103 • Number of events 14 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Headache
|
21.4%
22/103 • Number of events 27 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Psychiatric disorders
Anxiety
|
6.8%
7/103 • Number of events 7 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Psychiatric disorders
Depression
|
8.7%
9/103 • Number of events 11 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Psychiatric disorders
Insomnia
|
5.8%
6/103 • Number of events 6 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
14/103 • Number of events 14 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.8%
7/103 • Number of events 8 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
8/103 • Number of events 12 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
|
Vascular disorders
Hypertension
|
8.7%
9/103 • Number of events 12 • From start of study drug administration until week 182
The safety Population included all participants who received at least one dose of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER