Skip to main content

Table 1 Characteristics of reports associated with durvalumab from Q1 2004 to Q1 2024

From: A real-world disproportionality analysis of the US Food and Drug Administration (FDA) adverse event reporting system (FAERS) events for Durvalumab

Indicators

Number of patients (%)

Overall number of patients

9447

Gender

 Female

2620 (27.73)

 Male

5379 (56.94)

 Not Specified

1448 (15.33)

Age (years)

 < 18

4 (0.04)

 18–44

190 (2.01)

 45–64

2296 (24.30)

 65–74

2525 (26.73)

 ≥ 75

1346 (14.25)

 Not Specified

3086 (32.67)

 Mean (SD)

66.25 (10.38)

 Median (Q1, Q3)

67.83 (60.00, 73.07)

 Min, Max

0.00, 100.00

Reported person

 Consumer

1550 (16.41)

 Pharmacist

1091 (11.55)

 Physician

5707 (60.41)

 Other health-professional

142 (1.50)

 Not Specified

957 (10.13)

Reported countries

 

 Japan

2559 (27.09)

 United States of America

2115 (22.39)

 China

1113 (11.78)

 Canada

650 (6.88)

 France

562 (5.95)

Serious report

 

 Serious

8821 (93.37)

 Non-Serious

626 (6.63)

Outcome

 

 Life-Threatening

790 (8.36)

 Hospitalization-Initial or Prolonged

3234 (34.23)

 Disability

193 (2.04)

 Death

2870 (30.38)

 Congenital Anomaly

5 (0.05)

 Intervention

11 (0.12)

 Other

4503 (47.67)

Onset time (days)

 0–30

1552 (16.43)

 31–60

664 (7.03)

 61–90

391 (4.14)

 91–120

266 (2.82)

 121–150

165 (1.75)

 151–180

104 (1.10)

 181–360

324 (3.43)

 > 360

121 (1.28)

 Not Specified

5860 (62.03)

 Mean (SD)

83.74 (136.60)

 Median (Q1, Q3)

41.00 (14.00,99.00)

 Min, Max

0.00, 3657.00

Reporting year

 2014

2 (0.02)

 2015

1 (0.01)

 2016

3 (0.03)

 2017

178 (1.88)

 2018

621 (6.57)

 2019

1037 (10.98)

 2020

1880 (19.90)

 2021

1323 (14.00)

 2022

1290 (13.66)

 2023

2239 (23.70)

 2024

873 (9.24)

  1. For patients included in the analysis and administered the target medication, statistical description was conducted based on individual patient data. In cases where multiple adverse events occurred simultaneously within a patient, only one adverse event was considered for counting purposes