Table 3.
Sign or symptom | Total number of patients | Prevalence at enrolment |
TEAE |
AE |
AE vs TEAE |
|||
---|---|---|---|---|---|---|---|---|
n | Incidence | n | Incidence | Relative difference | ||||
Gastro-intestinal |
Anorexia |
1279 |
47% |
217 |
17% |
551 |
43% |
154% |
Abdominal |
740 |
46% |
66 |
9% |
202 |
27% |
206% |
|
|
Vomiting |
1277 |
34% |
188 |
15% |
392 |
31% |
108% |
|
Diarrhoea |
1278 |
20% |
214 |
17% |
315 |
25% |
47% |
|
Nausea |
726 |
18% |
22 |
3% |
107 |
15% |
386% |
Neurological |
Headache |
736 |
46% |
27 |
4% |
132 |
18% |
388% |
|
Dizziness |
519 |
2% |
3 |
1% |
15 |
3% |
399% |
|
Tinnitus |
200 |
1% |
1 |
1% |
1 |
1% |
0% |
Dermatological |
Pruritus |
756 |
26% |
141 |
19% |
192 |
25% |
36% |
|
Skin symptom |
759 |
24% |
97 |
13% |
118 |
16% |
22% |
Other |
Cough |
759 |
69% |
248 |
33% |
371 |
49% |
50% |
|
Weakness |
1119 |
59% |
176 |
16% |
470 |
42% |
167% |
|
Myalgia |
216 |
32% |
17 |
8% |
21 |
10% |
24% |
Jaundice | 759 | 2% | 4 | 1% | 4 | 1% | 0% |
* The total number of patients was different since different signs or symptoms were screened across the studies.