Table 1 Clinical characteristics of reports with omalizumab from the FAERS database.

From: A real-world pharmacovigilance study of omalizumab using disproportionality analysis in the FDA adverse drug events reporting system database

Characteristics

Case number, n

Case Proportion, %

Number of events

  

Gender

  

Female

32,485

65.7

Male

12,118

24.5

Missing

4853

9.8

Age

  

 < 18

2048

4.1

18–64.9

16,516

33.4

65–85

4143

8.4

 > 85

197

0.4

Missing

26,552

53.7

Weight

  

 < 50 kg

756

1.5

50–100 kg

6440

13.0

 > 100 kg

1707

3.5

Missing

40,553

82.0

Outcomes

  

Death (DE)

1954

4.0

Hospitalization(HO)

8249

16.7

Disability (DS)

380

0.8

Life-Threatening (LT)

1189

2.4

Other Serious

14,890

30.11

Missing

22,794

46.1

Reported Person(Top five)

  

Health professional

3485

7.0

Consumer

21,244

43

Physician

17,631

35.6

Other health-professional

5188

10.5

Pharmacist

1500

3.0

Reported countries(Top five)

  

America

33,177

67.08

Canada

5534

11.2

Switzerland

1605

3.2

Japan

978

2.0

Brazil

726

1.5

Indications (Top five)

  

Asthma

22,836

46.2

Chronic spontaneous urticaria

4886

9.9

Idiopathic urticaria

4583

9.3

Product used for unknown

10,331

20.9

Urticaria

2788

5.6