Table 5.
AE type and outcomes for AEs grade 1–3
| AE grade | System Organ Class (SOC)/AE type | AE outcome | Treatment interruption | Improvement after interr | Treatment restart | Alternative cause for AE | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| General disorders | Vascular disorders | Musculo-Skeletal disorders | Nervous System & Psychiatric disorders | Renal disorders | Gastroint. disorders | Reproduct system disorders | Skin disorders | |||||||
| BZB | 1 | 1 enlarged PAVM | 1 joint pain 1 facial pain |
2 hair loss | 1 unresolved/worsened 4 resolved |
1 Yes 4 No |
1 No | 1 No | In 2 | |||||
| 2 | 1 fatigue | 2 hypertension | 6 joint pain 1 vertebral fracture |
1 confusion 3 headaches |
2 proteinuria | 1 diarrhea | 17 resolved | 17 No | In 1 | |||||
| 3 | 1 fatigue | 3 hypertension 1 arterial thrombosisa |
2 joint pain | 1 confusion | 1 GI bleedingb 1 diarrhea |
1 unresolved/worsened 9 resolved |
3 Yes 7 No |
2 Yes 1 No |
1 Yes 2 No |
In 2 | ||||
| TH | 1 | 5 peripheral neuropathyc 1 somnolence 1 drowsiness |
1 rash | 2 unresolved/worsened 6 resolved |
3 Yes 5 No |
3 Yes | 3 No | none | ||||||
| 2 | 5 peripheral neuropathyd 4 dizziness 2 somnolence 7 drowsiness |
1 constipation | 1 erectile dysfunction | 7 unresolved/worsened 2 resolved with sequelae 11 resolved |
15 Yes 5 No |
10 Yes 5 No |
15 No | none | ||||||
| 3 | 1 limb edema | 1 arterial thrombosisf | 2 peripheral neuropathy & 2 dizziness |
4 unresolved/worsened 2 resolved |
4 Yes 2 No |
2 Yes 2 No |
1 Yes 3 No |
In 1 | ||||||
Legend: aunresolved/worsened after treatment interruption
bresolved completely
c3 resolved completely, 2 unresolved/worsened,
d1 resolved completely, 1 resolved with sequelae, 3 unresolved/worsened
&2 unresolved/worsened
fresolved completely