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Table 2 Results of signal detection for adverse events of anti-IL-5 drugs

From: Adverse events of anti-IL-5 drugs in patients with eosinophilic asthma: a meta-analysis of randomized controlled trials and real-world evidence-based assessments

SOC/PT

Event (A)

PRR

X2

E (IC)-2SD

Blood And Lymphatic System Disorders

    

Eosinophiliaa

328

20.67

5819.59

3.84

Gastrointestinal Disorders

    

Gastrooesophageal Reflux Disease

350

5.29

1204.78

2.01

General Disorders And Administration Site Conditions

    

Adverse Drug Reaction

298

3.33

482.35

1.33

Chest Discomforta

1271

15.05

16,068.74

3.65

Chest Pain

502

3.68

973.47

1.56

Chills

341

3.56

622.70

1.45

Condition Aggravated

1091

3.57

2024.68

1.62

Fatigue

1491

2.06

832.45

0.86

Ill-Defined Disorder

350

9.56

2617.90

2.83

Illness

539

2.89

665.60

1.23

Injection Site Pain

527

2.43

445.14

0.98

Malaise

1351

4.30

3416.87

1.90

Oedema Peripheral

279

3.77

564.38

1.49

Pyrexia

1040

3.51

1873.04

1.59

Secretion Dischargea

250

21.57

4635.53

3.81

Therapeutic Product Effect Incompletea

3121

23.66

63,994.22

4.34

Immune System Disorders

    

Anaphylactic Reaction

249

5.41

884.83

1.97

Hypersensitivity

562

3.07

781.31

1.32

Infections And Infestations

    

Bronchitis

414

6.74

1990.83

2.38

Covid-19

499

2.13

298.28

0.78

Herpes Zoster

288

5.28

988.19

1.97

Infection

501

3.76

1008.76

1.59

Influenza

679

6.74

3272.32

2.46

Lower Respiratory Tract Infectiona

643

14.77

7951.78

3.53

Nasopharyngitis

947

5.86

3774.96

2.30

Pneumonia

2560

8.71

17,260.09

2.95

Respiratory Tract Infectiona

375

16.48

5223.38

3.58

Sinusitis

610

6.92

3040.83

2.48

Upper Respiratory Tract Infection

304

8.04

1837.83

2.56

Injury, Poisoning And Procedural Complications

    

Accidental Exposure To Product

453

4.42

1186.84

1.80

Exposure Via Skin Contacta

490

120.58

43,858.25

5.93

Inappropriate Schedule Of Product Administration

776

2.87

946.59

1.27

Product Dose Omission Issue

2199

3.92

4828.04

1.81

Underdose

274

4.14

647.65

1.62

Wrong Technique In Device Usage Process

542

9.18

3861.21

2.85

Investigations

    

Blood Pressure Increased

446

3.14

646.44

1.32

Blood Test Abnormala

259

18.36

4054.03

3.62

Eosinophil Count Increaseda

560

78.66

35,435.09

5.56

Full Blood Count Abnormala

1922

60.09

96,236.90

5.49

Heart Rate Increased

282

3.41

478.38

1.35

Oxygen Saturation Decreased

279

5.05

896.95

1.90

Weight Increased

410

2.12

243.80

0.75

Musculoskeletal And Connective Tissue Disorders

    

Arthralgia

791

2.09

451.03

0.81

Back Pain

696

3.47

1218.45

1.52

Myalgia

420

3.07

584.62

1.28

Pain In Extremity

561

2.24

384.08

0.87

Nervous System Disorders

    

Headache

1582

2.90

1991.73

1.35

Product Issues

    

Product Complainta

515

12.17

5120.31

3.23

Psychiatric Disorders

    

Sleep Disorder

247

3.89

526.57

1.51

Sleep Disorder Due To A General Medical Conditiona

1766

189.72

219,426.83

6.69

Respiratory, Thoracic And Mediastinal Disorders

    

Asthmaa

8071

95.40

601,908.84

6.15

Asthmatic Crisisa

486

172.80

56,633.75

6.23

Bronchiectasisa

313

54.01

14,218.65

4.96

Chronic Obstructive Pulmonary Diseasea

554

13.09

5985.27

3.34

Cougha

3162

12.62

33,004.38

3.48

Dysphonia

317

6.19

1357.85

2.21

Dyspnoeaa

6395

13.22

70,989.84

3.58

Dyspnoea Exertionala

724

19.89

12,344.85

3.95

Lung Disorder

436

9.95

3421.92

2.93

Nasal Congestiona

667

13.45

7429.47

3.41

Nasal Polypsa

355

139.31

35,440.36

5.91

Obstructive Airways Disordera

1420

133.11

137,080.89

6.32

Oropharyngeal Pain

510

6.17

2178.26

2.29

Productive Cougha

1413

32.38

39,585.24

4.68

Pulmonary Massa

291

19.70

4906.56

3.74

Respiratory Disordera

291

11.76

2779.49

3.07

Rhinorrhoea

463

7.44

2536.10

2.54

Sputum Discoloureda

683

77.22

42,544.86

5.60

Upper-Airway Cough Syndromea

285

40.57

9917.96

4.61

Wheezinga

4134

90.04

293,468.35

6.04

Skin And Subcutaneous Tissue Disorders

    

Rash

845

2.03

448.55

0.79

Urticaria

550

3.84

1146.86

1.63

Social Circumstances

    

Loss Of Personal Independence In Daily Activitiesa

2492

39.39

84,484.01

4.99

Surgical And Medical Procedures

    

Hospitalisation

927

6.17

3974.32

2.37

Vascular Disorders

    

Hypertension

555

3.13

804.20

1.35

  1. aIndicates strong signals