|
Variable
|
No. (%)
|
P
|
|
Kymriah (n=499)
|
Yescarta (n=701)
|
| Type of ADR |
|
|
|
| Immune system disorders |
261 (52) |
433 (62) |
0.001 |
| Cytokine release syndrome (CRS) |
237 (47) |
426 (61) |
< 0.001 |
| Nervous system disorders |
153 (31) |
422 (60) |
| General disorders and administration site conditions |
259 (52) |
286 (41) |
| Blood and lymphatic system disorders |
150 (30) |
137 (20) |
| Cardiac disorders |
58 (12) |
119 (17) |
0.1 |
| Psychiatric disorders |
52 (10) |
109 (16) |
0.01 |
| Vascular disorders |
99 (20) |
104 (15) |
0.024 |
| Infections and infestations |
112 (22) |
99 (14) |
< 0.001 |
| Investigations |
173 (35) |
92 (13) |
| Respiratory, thoracic and mediastinal disorders |
89 (18) |
83 (12) |
0.004 |
| Gastrointestinal disorders |
64 (13) |
72 (10) |
0.196 |
| Benign Neoplasms, Malignant Neoplasm and unspecified (incl cysts and polyps) |
120 (24) |
49 (7) |
< 0.001 |
| Renal and urinary disorders |
39 (8) |
39 (6) |
0.124 |
| Metabolism and nutrition disorders |
49 (10) |
29 (4) |
< 0.001 |
| Injury, poisoning and procedural complications |
21 (4) |
26 (4) |
0.654 |
| Musculoskeletal and connective tissue disorders |
26 (5) |
25 (4) |
0.191 |
| Skin and subcutaneous tissue disorders |
23 (5) |
15 (2) |
0.019 |
| Surgical and medical procedures |
0 |
15 (2) |
0.031 |
| Hepatobiliary disorders |
15 (3) |
11 (2) |
0.108 |
| Eye disorders |
17 (3.4) |
8 (1) |
0.12 |
| Endocrine disorders |
3 (0.6) |
7 (0.9) |
0.536 |
| Social circumstances |
1 (0.2) |
5 (0.7) |
0.41 |
| Congenital, familial and genetic disorders |
1 (0.2) |
3 (0.4) |
0.645 |
| Product issues |
14 (3) |
3 (0.4) |
0.001 |
| Reproductive system and breast disorders |
2 (0.4) |
1 (0.1) |
0.574 |
| Ear and labyrinth disorders |
3 (0.6) |
0 |
0.072 |
| Age group |
|
|
|
| 28 days to 23 months |
7 |
— |
|
| 2 - 11 years |
106 |
— |
|
| 12 - 17 years |
85 |
1 |
|
| 18 - 44 years |
95 |
80 |
|
| 45 - 64 years |
43 |
245 |
|
| 65 - 74 years |
29 |
141 |
|
| ≥ 75 years |
7 |
23 |
|
| Unknown |
127 |
211 |
|
| ADR reports per year |
|
|
|
| 2019 (up to August 2019) |
322 |
585 |
|
| 2018 |
162 |
116 |
|
| 2017 |
8 |
— |
|
| 2016 |
5 |
— |
|
| 2015 |
2 |
— |
|
| Geographical distribution |
|
|
|
| Americas |
407 |
623 |
|
| Europe |
82 |
78 |
|
| Oceania |
10 |
— |
|
