Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Benralizumab 30 mg q.4 Weeks
|
Benralizumab 30 mg q.8 Weeks
|
Placebo
|
Arm/Group Description |
Benralizumab administered subcutane...
|
Benralizumab administered subcutane...
|
Placebo administered subcutaneously
|
Arm/Group Description |
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab administered subcutaneously every 8 weeks
|
Placebo administered subcutaneously
|
|
|
Benralizumab 30 mg q.4 Weeks
|
Benralizumab 30 mg q.8 Weeks
|
Placebo
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
--/--
|
|
--/--
|
|
--/--
|
|
|
|
Benralizumab 30 mg q.4 Weeks
|
Benralizumab 30 mg q.8 Weeks
|
Placebo
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
46/438 (10.50%)
|
|
41/428 (9.58%)
|
|
61/440 (13.86%)
|
|
Blood and lymphatic system disorders |
|
|
|
Anaemia |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Cardiac disorders |
|
|
|
Acute coronary syndrome |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Acute myocardial infarction |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
2 |
Angina pectoris |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Aortic valve stenosis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Atrial fibrillation |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Atrioventricular block complete |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Cardiac arrest |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Cardiac failure congestive |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Coronary artery disease |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Myocardial infarction |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Myocardial ischaemia |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
2/440 (0.45%)
|
2 |
Supraventricular tachycardia |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Eye disorders |
|
|
|
Cataract |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
Gastritis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Gastroduodenitis |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Inguinal hernia |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Large intestine polyp |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Rectal polyp |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
General disorders |
|
|
|
Chest pain |
1/438 (0.23%)
|
1 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Death |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Non-cardiac chest pain |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Hepatobiliary disorders |
|
|
|
Cholecystitis |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Cholecystitis acute |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Cholecystitis chronic |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Cholelithiasis |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Hepatitis alcoholic |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Immune system disorders |
|
|
|
Anaphylactic reaction |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Drug hypersensitivity |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
1/440 (0.23%)
|
1 |
Infections and infestations |
|
|
|
Appendicitis |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Bacterial infection |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Bronchitis |
1/438 (0.23%)
|
1 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Bronchitis haemophilus |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Chronic sinusitis |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Cytomegalovirus hepatitis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Gastroenteritis |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Herpes zoster |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Influenza |
0/438 (0.00%)
|
0 |
2/428 (0.47%)
|
2 |
0/440 (0.00%)
|
0 |
Liver abscess |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Pneumonia |
2/438 (0.46%)
|
2 |
0/428 (0.00%)
|
0 |
4/440 (0.91%)
|
6 |
Pneumonia bacterial |
2/438 (0.46%)
|
2 |
0/428 (0.00%)
|
0 |
3/440 (0.68%)
|
3 |
Pseudomonas bronchitis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Pseudomonas infection |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Respiratory tract infection bacterial |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Sepsis |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Sinusitis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Upper respiratory tract infection |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Urinary tract infection |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
Anastomotic ulcer |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Humerus fracture |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Injury |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Joint injury |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Patella fracture |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Procedural complication |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Road traffic accident |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Thermal burn |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Toxicity to various agents |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
Obesity |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
Back pain |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Dupuytren's contracture |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Epiphysiolysis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Intervertebral disc disorder |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Jaw cyst |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Muscular weakness |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Osteoarthritis |
1/438 (0.23%)
|
1 |
1/428 (0.23%)
|
1 |
1/440 (0.23%)
|
1 |
Rheumatoid arthritis |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Rotator cuff syndrome |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Spinal osteoarthritis |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Spondylolisthesis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Breast cancer female |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Colon neoplasm |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Gallbladder cancer |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Gastric cancer |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Thyroid adenoma |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Uterine leiomyoma |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
Cerebrovascular accident |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Lumbar radiculopathy |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
2 |
Sciatica |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Seizure |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Syncope |
1/438 (0.23%)
|
1 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Transient ischaemic attack |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Psychiatric disorders |
|
|
|
Completed suicide |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Depression |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
Calculus ureteric |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Nephrolithiasis |
2/438 (0.46%)
|
3 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
|
Benign prostatic hyperplasia |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Asthma |
21/438 (4.79%)
|
25 |
19/428 (4.44%)
|
27 |
23/440 (5.23%)
|
38 |
Hyperventilation |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Nasal polyps |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Nasal turbinate hypertrophy |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Pleural effusion |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
Parakeratosis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Urticaria |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Urticaria papular |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
0/440 (0.00%)
|
0 |
Vascular disorders |
|
|
|
Aortic stenosis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Hypertension |
0/438 (0.00%)
|
0 |
1/428 (0.23%)
|
1 |
1/440 (0.23%)
|
1 |
Hypertensive crisis |
1/438 (0.23%)
|
1 |
0/428 (0.00%)
|
0 |
0/440 (0.00%)
|
0 |
Phlebitis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Venous thrombosis |
0/438 (0.00%)
|
0 |
0/428 (0.00%)
|
0 |
1/440 (0.23%)
|
1 |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 18.1
|
|
Frequency Threshold for Reporting Other Adverse Events
|
3%
|
|
Benralizumab 30 mg q.4 Weeks
|
Benralizumab 30 mg q.8 Weeks
|
Placebo
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
244/438 (55.71%)
|
|
232/428 (54.21%)
|
|
264/440 (60.00%)
|
|
General disorders |
|
|
|
Pyrexia |
16/438 (3.65%)
|
20 |
13/428 (3.04%)
|
13 |
6/440 (1.36%)
|
6 |
Infections and infestations |
|
|
|
Acute sinusitis |
6/438 (1.37%)
|
6 |
5/428 (1.17%)
|
6 |
14/440 (3.18%)
|
19 |
Bronchitis |
40/438 (9.13%)
|
51 |
45/428 (10.51%)
|
54 |
54/440 (12.27%)
|
72 |
Influenza |
24/438 (5.48%)
|
27 |
12/428 (2.80%)
|
17 |
25/440 (5.68%)
|
27 |
Nasopharyngitis |
90/438 (20.55%)
|
132 |
82/428 (19.16%)
|
131 |
92/440 (20.91%)
|
147 |
Pharyngitis |
17/438 (3.88%)
|
21 |
10/428 (2.34%)
|
10 |
8/440 (1.82%)
|
9 |
Rhinitis |
12/438 (2.74%)
|
13 |
18/428 (4.21%)
|
24 |
17/440 (3.86%)
|
22 |
Sinusitis |
23/438 (5.25%)
|
31 |
21/428 (4.91%)
|
30 |
39/440 (8.86%)
|
56 |
Upper respiratory tract infection |
29/438 (6.62%)
|
35 |
37/428 (8.64%)
|
53 |
42/440 (9.55%)
|
53 |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
8/438 (1.83%)
|
10 |
14/428 (3.27%)
|
16 |
10/440 (2.27%)
|
14 |
Back pain |
17/438 (3.88%)
|
18 |
11/428 (2.57%)
|
11 |
16/440 (3.64%)
|
20 |
Nervous system disorders |
|
|
|
Headache |
33/438 (7.53%)
|
63 |
34/428 (7.94%)
|
65 |
32/440 (7.27%)
|
57 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Asthma |
50/438 (11.42%)
|
76 |
32/428 (7.48%)
|
50 |
52/440 (11.82%)
|
96 |
Cough |
10/438 (2.28%)
|
11 |
14/428 (3.27%)
|
18 |
8/440 (1.82%)
|
12 |
Rhinitis allergic |
21/438 (4.79%)
|
25 |
16/428 (3.74%)
|
19 |
24/440 (5.45%)
|
28 |
Vascular disorders |
|
|
|
Hypertension |
12/438 (2.74%)
|
12 |
18/428 (4.21%)
|
23 |
22/440 (5.00%)
|
24 |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 18.1
|