Table 2 Clinical characteristics of adverse events with durvalumab as the primary suspected drug (January 2017 to June 2024).
From: A pharmacovigilance analysis of post-marketing safety of durvalumab
Characteristics | Report number, n | Report proportion, % |
|---|---|---|
Number of reports | 10,120 | |
Gender | ||
Female | 2820 | 27.9 |
Male | 5760 | 56.9 |
Unknown or missing | 1540 | 15.2 |
Age (years) | ||
<18 | 4 | 0.0 |
18 ≤ and<45 | 198 | 2.0 |
45 ≤ and<65 | 2381 | 23.5 |
≥ 65 | 4067 | 40.2 |
Unknown | 3470 | 34.3 |
Median age (Q1,Q3) | 68.00 (60.00,73.35) | |
Major indication (Top six) | ||
Non-small cell lung cancer | 3488 | 34.5 |
Small cell lung cancer | 1321 | 13.1 |
Hepatocellular carcinoma | 522 | 5.2 |
Lung neoplasm malignant | 463 | 4.6 |
Bile duct cancer | 458 | 4.5 |
Not Specified | 1874 | 18.5 |
Reporting country (Top Five) | ||
Japan | 2763 | 27.3 |
America | 2223 | 22.0 |
China | 1214 | 12.0 |
Canada | 683 | 6.8 |
France | 630 | 6.2 |
Serious outcome | ||
Hospitalization - Initial or Prolonged | 3389 | 33.5 |
Death | 3089 | 30.5 |
Life-Threatening | 851 | 8.4 |
Disability | 210 | 2.1 |
Required Intervention to Prevent Permanent Impairment/Damage | 11 | 0.1 |
Congenital Anomaly | 6 | 0.1 |
Other | 4857 | 48.0 |
Report year | ||
2017 | 178 | 1.8 |
2018 | 621 | 6.1 |
2019 | 1037 | 10.2 |
2020 | 1876 | 18.5 |
2021 | 1324 | 13.1 |
2022 | 1290 | 12.8 |
2023 | 2219 | 21.9 |
2024 | 1575 | 15.6 |
Reported Person | ||
Physician | 6112 | 60.4 |
Consumer | 1746 | 17.3 |
Pharmacist | 1164 | 11.5 |
Lawyer | 1 | 0.0 |
Other health-professional | 140 | 1.4 |
Not Specified | 957 | 9.5 |
The tine to onset (days) | ||
0–30 | 1623 | 16.0 |
31–60 | 686 | 6.8 |
61–90 | 401 | 4.0 |
91–180 | 550 | 5.4 |
181–360 | 336 | 3.3 |
≥ 360 | 123 | 1.2 |
NotSpecified | 6401 | 63.3 |
Median time to onset (Q1,Q3) | 40.00(14.00,99.00) | |
Serious or non-serious reports | ||
Serious | 9444 | 93.3% |
Non-Serious | 676 | 6.7% |
