Trial Outcomes & Findings for An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults (NCT NCT01753193)
NCT ID: NCT01753193
Last Updated: 2019-07-31
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
218 participants
Primary outcome timeframe
From first dose of study drug (Day 1) through 168 weeks
Results posted on
2019-07-31
Participant Flow
The study was conducted from 28 Mar 2013 to 18 Jul 2018.
A total of 218 participants were enrolled in this open-label extension (OLE) study.
Participant milestones
| Measure |
Anifrolumab
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Overall Study
STARTED
|
218
|
|
Overall Study
COMPLETED
|
172
|
|
Overall Study
NOT COMPLETED
|
46
|
Reasons for withdrawal
| Measure |
Anifrolumab
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
23
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other
|
16
|
Baseline Characteristics
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
Baseline characteristics by cohort
| Measure |
Anifrolumab
n=218 Participants
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Age, Continuous
|
40.8 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
203 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
85 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug (Day 1) through 168 weeksPopulation: As-treated population included all participants who received any dose of study drug in the OLE study.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Anifrolumab
n=218 Participants
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
170 Participants
|
|
Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
50 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug (Day 1) through 168 weeksPopulation: As-treated population included all participants who received any dose of study drug in the OLE study.
Number of participants with DAEs are reported.
Outcome measures
| Measure |
Anifrolumab
n=218 Participants
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab
|
17 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug (Day 1) through 168 weeksPopulation: As-treated population included all participants who received any dose of study drug in the OLE study.
An AESI is scientific and medical concern specific to understanding of the study drug. An AESI may be serious or non-serious. Number of participants with AESIs are reported.
Outcome measures
| Measure |
Anifrolumab
n=218 Participants
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
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|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Herpes zoster
|
11 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Drug hypersensitivity
|
1 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Hypersensitivity
|
2 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Infusion related reaction
|
4 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Nausea
|
1 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Hodgkin's disease
|
1 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Latent tuberculosis
|
5 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Hypersensitivity vasculitis
|
1 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Vasculitis
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Day 1) up to Week 168Population: As-treated population included all participants who received any dose of study drug in the OLE study. Participants with reportable ADA titer results were analyzed for this outcome measure.
The number of participants with positive serum antibodies to anifrolumab at anytime (including baseline) are reported.
Outcome measures
| Measure |
Anifrolumab
n=216 Participants
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Day 1) up to Week 168Population: As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.
Median ADA titer in participants with ADA-positive assessments and reportable ADA titer results are reported.
Outcome measures
| Measure |
Anifrolumab
n=5 Participants
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Anti-Drug Antibodies (ADA) Titer to Anifrolumab
|
120 Antibody titers
Interval 30.0 to 120.0
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Day 1) up to Week 168Population: As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.
Number of participants with decreased serum concentration of anifrolumab due to ADA-positive results are reported.
Outcome measures
| Measure |
Anifrolumab
n=5 Participants
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Day 1) up to Week 168Population: As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.
Number of participants with decreased pharmacodynamic response of anifrolumab due to ADA-positive results are reported.
Outcome measures
| Measure |
Anifrolumab
n=5 Participants
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Day 1); and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 160, and 168Population: As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.
The SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).
Outcome measures
| Measure |
Anifrolumab
n=5 Participants
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Baseline
|
7.8 Units on Score
Standard Deviation 7.6
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 12
|
5 Units on Score
Standard Deviation 2.0
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 24
|
1.5 Units on Score
Standard Deviation 1.9
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 36
|
2.0 Units on Score
Standard Deviation 2.3
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 48
|
1.8 Units on Score
Standard Deviation 2.0
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 60
|
2.0 Units on Score
Standard Deviation 1.6
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 72
|
4.0 Units on Score
Standard Deviation 5.7
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 84
|
3.0 Units on Score
Standard Deviation 1.4
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 96
|
3.0 Units on Score
Standard Deviation 1.4
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 108
|
4.0 Units on Score
Standard Deviation 0.0
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 120
|
5.0 Units on Score
Standard Deviation 1.4
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 132
|
4.0 Units on Score
Standard Deviation 0.0
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 144
|
7.0 Units on Score
Standard Deviation 7.1
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 156
|
6.0 Units on Score
Standard Deviation 2.8
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 160
|
2.0 Units on Score
Standard Deviation 2.8
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Week 168
|
2.0 Units on Score
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Day 1) up to Week 168Population: As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.
The number of ADA-positive participants with TEAEs and TESAEs are reported.
Outcome measures
| Measure |
Anifrolumab
n=5 Participants
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Number of ADA-positive Participants With TEAEs and TESAEs
TEAEs
|
5 Participants
|
|
Number of ADA-positive Participants With TEAEs and TESAEs
TESAEs
|
1 Participants
|
Adverse Events
Anifrolumab
Serious events: 50 serious events
Other events: 164 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Anifrolumab
n=218 participants at risk
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.46%
1/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Pericarditis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Endocrine disorders
Hypothalamic pituitary adrenal axis suppression
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Cataract
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
General disorders
Asthenia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
General disorders
Cyst
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
General disorders
Mucosal inflammation
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Abscess limb
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Bronchitis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Cellulitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Chikungunya virus infection
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Dengue fever
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Diverticulitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Herpes zoster
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Latent tuberculosis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Mastoiditis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Otitis media
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pneumonia
|
1.8%
4/218 • Number of events 5 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Post procedural infection
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pyelonephritis acute
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Tooth abscess
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.92%
2/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.3%
5/218 • Number of events 5 • From first dose of study drug (Day 1) through 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.46%
1/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Dizziness
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Epilepsy
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Idiopathic intracranial hypertension
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.46%
1/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Syncope
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Pregnancy, puerperium and perinatal conditions
High risk pregnancy
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.92%
2/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
Other adverse events
| Measure |
Anifrolumab
n=218 participants at risk
Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
|
|---|---|
|
Reproductive system and breast disorders
Menorrhagia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Uterine cervical erosion
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
2.3%
5/218 • Number of events 5 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.8%
4/218 • Number of events 9 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.8%
4/218 • Number of events 5 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Scar
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Blood immunoglobulin a decreased
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Blood potassium decreased
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Electrocardiogram qt shortened
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Lipids abnormal
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Liver function test increased
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Mycobacterium tuberculosis complex test positive
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Neutrophil count increased
|
0.92%
2/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Nuclear magnetic resonance imaging brain abnormal
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Transaminases increased
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Weight decreased
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Investigations
Weight increased
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Metabolism and nutrition disorders
Acquired mixed hyperlipidaemia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
5/218 • Number of events 6 • From first dose of study drug (Day 1) through 168 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
4/218 • Number of events 5 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
7/218 • Number of events 8 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.2%
7/218 • Number of events 7 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
3/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
3/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.92%
2/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.4%
3/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.92%
2/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Endometriosis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulvovaginal warts
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Dizziness
|
2.3%
5/218 • Number of events 6 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Encephalopathy
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Headache
|
6.4%
14/218 • Number of events 21 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Hypersomnia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Intercostal neuralgia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Migraine
|
1.8%
4/218 • Number of events 6 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Pineal gland cyst
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Seizure
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Syncope
|
1.8%
4/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Nervous system disorders
Visual field defect
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Psychiatric disorders
Anxiety
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Psychiatric disorders
Bipolar disorder
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Psychiatric disorders
Depressed mood
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Psychiatric disorders
Depression
|
1.4%
3/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Psychiatric disorders
Insomnia
|
1.8%
4/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Psychiatric disorders
Libido decreased
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Renal and urinary disorders
Nephritis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Breast discharge
|
0.46%
1/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
6/218 • Number of events 6 • From first dose of study drug (Day 1) through 168 weeks
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Blood and lymphatic system disorders
Leukaemoid reaction
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.92%
2/218 • Number of events 6 • From first dose of study drug (Day 1) through 168 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.46%
1/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Bifascicular block
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Bundle branch block right
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Left atrial dilatation
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Myocardial fibrosis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Palpitations
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Tachycardia
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Endocrine disorders
Hyperparathyroidism
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Endocrine disorders
Thyroid mass
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Blepharitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Blepharochalasis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Cataract
|
1.8%
4/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Chalazion
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Eyelid oedema
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Macular degeneration
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Myopia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Scleritis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Vision blurred
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Eye disorders
Visual acuity reduced
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.92%
2/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
5/218 • Number of events 6 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Constipation
|
2.3%
5/218 • Number of events 5 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
11/218 • Number of events 12 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Enteritis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Gastric mucosa erythema
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Gastritis
|
3.2%
7/218 • Number of events 7 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Internal hernia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.2%
7/218 • Number of events 8 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
General disorders
Acquired gene mutation
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
General disorders
Asthenia
|
1.8%
4/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
General disorders
Cyst
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
General disorders
Influenza like illness
|
2.8%
6/218 • Number of events 10 • From first dose of study drug (Day 1) through 168 weeks
|
|
General disorders
Oedema peripheral
|
1.8%
4/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
General disorders
Pyrexia
|
2.3%
5/218 • Number of events 5 • From first dose of study drug (Day 1) through 168 weeks
|
|
General disorders
Tenderness
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.4%
3/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
0.92%
2/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Acarodermatitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Acute sinusitis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Appendicitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Bacterial vaginosis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Body tinea
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Bone abscess
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Bronchitis
|
12.8%
28/218 • Number of events 33 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Bronchitis bacterial
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Bronchitis viral
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Candida infection
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Cellulitis
|
1.4%
3/218 • Number of events 8 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Cervicitis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Conjunctivitis
|
1.4%
3/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Cystitis
|
1.4%
3/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Dermatophytosis of nail
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Ear infection
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Furuncle
|
1.4%
3/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.3%
5/218 • Number of events 6 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
1.8%
4/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Genital candidiasis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Genital herpes simplex
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Herpes simplex
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Herpes zoster
|
4.6%
10/218 • Number of events 10 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Infected bite
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Influenza
|
4.1%
9/218 • Number of events 10 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Latent tuberculosis
|
2.3%
5/218 • Number of events 5 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Lymphangitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Nail infection
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Nasopharyngitis
|
14.7%
32/218 • Number of events 40 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Onychomycosis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Oral candidiasis
|
0.92%
2/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Oral herpes
|
2.8%
6/218 • Number of events 7 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Otitis media
|
1.8%
4/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Papilloma viral infection
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Paronychia
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Parotitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Peritonsillar abscess
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pharyngitis
|
4.6%
10/218 • Number of events 11 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.4%
3/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pharyngotonsillitis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pleurisy viral
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pneumonia
|
1.8%
4/218 • Number of events 6 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pulpitis dental
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Pyelonephritis acute
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Rhinitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Sinusitis
|
3.7%
8/218 • Number of events 12 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Skin candida
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Skin infection
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Streptococcal infection
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.92%
2/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Tinea manuum
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Tonsillitis
|
1.4%
3/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Tracheobronchitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
9.2%
20/218 • Number of events 29 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.0%
13/218 • Number of events 17 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Urinary tract infection fungal
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Vaginal infection
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Viral infection
|
2.3%
5/218 • Number of events 5 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.3%
5/218 • Number of events 6 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Vulval abscess
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.4%
3/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Vulvovaginitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Infections and infestations
Zika virus infection
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
5/218 • Number of events 5 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.46%
1/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Mechanical urticaria
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
1.4%
3/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.92%
2/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.92%
2/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.92%
2/218 • Number of events 4 • From first dose of study drug (Day 1) through 168 weeks
|
|
Vascular disorders
Hypertension
|
1.4%
3/218 • Number of events 3 • From first dose of study drug (Day 1) through 168 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.46%
1/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Vascular disorders
Peripheral coldness
|
0.46%
1/218 • Number of events 2 • From first dose of study drug (Day 1) through 168 weeks
|
|
Vascular disorders
Peripheral venous disease
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Vascular disorders
Phlebitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Vascular disorders
Raynaud's phenomenon
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
|
Vascular disorders
Vasculitis
|
0.46%
1/218 • Number of events 1 • From first dose of study drug (Day 1) through 168 weeks
|
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 on going 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.
- Publication restrictions are in place
Restriction type: OTHER