≥1 TEAE
|
3 (75.0)
|
1 (100.0)
|
4 (100.0)
|
6 (100.0)
|
5 (83.3)
|
7 (100.0)
|
23 (95.8)
|
≥1 grade 3 TEAE
|
0
|
1 (100.0)
|
0
|
2 (33.3)
|
2 (33.3)
|
2 (28.6)
|
7 (29.2)
|
≥1 grade 4 TEAE
|
0
|
0
|
0
|
0
|
1 (16.7)
|
0
|
1 (4.2)
|
Death
|
0
|
0
|
0
|
0
|
1 (16.7)
|
0
|
0
|
≥1 SAE
|
0
|
1 (100.0)
|
1 (25.0)
|
1 (16.7)
|
2 (33.3)
|
1 (14.3)
|
6 (25.0)
|
≥1 study drug-related TEAE
|
0
|
0
|
2 (50.0)
|
4 (66.7)
|
4 (66.7)
|
4 (57.1)
|
14 (58.3)
|
≥1 study drug-related SAE
|
0
|
0
|
1 (25.0)
|
1 (16.7)
|
0
|
0
|
2 (8.3)
|
Treatment-related TEAEs and SAEs, by MedDRA preferred term
|
Infusion-related reaction
|
0
|
0
|
1 (25.0)
|
2 (33.3)
|
1 (16.7)
|
0
|
4 (16.7)
|
Cough
|
0
|
0
|
0
|
0
|
0
|
2 (28.6)
|
2 (8.3)
|
Diarrhea
|
0
|
0
|
0
|
0
|
1 (16.7)
|
0
|
1 (4.2)
|
Fatigue
|
0
|
0
|
0
|
0
|
0
|
1 (14.3)
|
1 (4.2)
|
Flushing
|
0
|
0
|
0
|
1 (16.7)
|
0
|
0
|
1 (4.2)
|
Headache
|
0
|
0
|
0
|
0
|
0
|
1 (14.3)
|
1 (4.2)
|
Hot flush
|
0
|
0
|
0
|
1 (16.7)
|
0
|
0
|
1 (4.2)
|
Hyperglycemia
|
0
|
0
|
0
|
0
|
1 (16.7)
|
0
|
1 (4.2)
|
Lip swelling
|
0
|
0
|
0
|
0
|
1 (16.7)
|
0
|
1 (4.2)
|
Night sweats
|
0
|
0
|
0
|
0
|
0
|
1 (14.3)
|
1 (4.2)
|
Rash
|
0
|
0
|
0
|
0
|
1 (16.7)
|
0
|
1 (4.2)
|
Subclavian vein thrombosis
|
0
|
0
|
0
|
1 (16.7)
|
0
|
0
|
1 (4.2)
|
Supraventricular extrasystoles
|
0
|
0
|
0
|
0
|
0
|
1 (14.3)
|
1 (4.2)
|
Supraventricular tachycardia
|
0
|
0
|
1 (25.0)
|
0
|
0
|
0
|
1 (4.2)
|
Tongue ulceration
|
0
|
0
|
0
|
0
|
0
|
1 (14.3)
|
1 (4.2)
|
Upper respiratory tract infection
|
0
|
0
|
0
|
0
|
1 (16.7)
|
0
|
1 (4.2)
|