Table 3 Overview of adverse event profile in Part A and Part B (patients with all TEAEs occurring in at least three patients and their associated treatment-related TEAEs)—safety populations.
TEAEs, n (%) | Treatment-related TEAEs, n (%) | |||||||
|---|---|---|---|---|---|---|---|---|
All grades | Grade 1 | Grade 2 | Grade ≥3 | All Grades | Grade 1 | Grade 2 | Grade ≥3 | |
Part A (N = 16) | ||||||||
Any TEAE | 16 (100) | 5 (31.3) | 7 (43.8) | 4 (25.0) | 13 (81.3) | 10 (62.5) | 3 (18.8) | 0 |
Constipation | 6 (37.5) | 5 (31.3) | 1 (6.3) | 0 | 3 (18.8) | 3 (18.8) | 0 | 0 |
Decreased appetite | 6 (37.5) | 6 (37.5) | 0 | 0 | 3 (18.8) | 3 (18.8) | 0 | 0 |
Diarrhea | 6 (37.5) | 5 (31.3) | 1 (6.3) | 0 | 4 (25.0) | 3 (18.8) | 1 (6.3) | 0 |
Hot flush | 6 (37.5) | 6 (37.5) | 0 | 0 | 5 (31.3) | 5 (31.3) | 0 | 0 |
Nausea | 6 (37.5) | 3 (18.8) | 3 (18.8) | 0 | 4 (25.0) | 3 (18.8) | 1 (6.3) | 0 |
Arthralgia | 5 (31.3) | 2 (12.5) | 3 (18.8) | 0 | 2 (12.5) | 1 (6.3) | 1 (6.3) | 0 |
Asthenia | 4 (25.0) | 2 (12.5) | 2 (12.5) | 0 | 3 (18.8) | 3 (18.8) | 0 | 0 |
Dyspnea | 4 (25.0) | 2 (12.5) | 1 (6.3) | 1 (6.3) | 1 (6.3) | 1 (6.3) | 0 | 0 |
Fatigue | 4 (25.0) | 3 (18.8) | 0 | 1 (6.3) | 2 (12.5) | 2 (12.5) | 0 | 0 |
Urinary tract infection | 4 (25.0) | 0 | 3 (18.8) | 1 (6.3) | 0 | 0 | 0 | 0 |
Back pain | 3 (18.8) | 2 (12.5) | 0 | 1 (6.3) | 1 (6.3) | 1 (6.3) | 0 | 0 |
Hypoesthesia | 3 (18.8) | 3 (18.8) | 0 | 0 | 0 | 0 | 0 | 0 |
Night sweat | 3 (18.8) | 3 (18.8) | 0 | 0 | 3 (18.8) | 3 (18.8) | 0 | 0 |
Part B (N = 49) | ||||||||
Any TEAE | 49 (100) | 11 (22.4) | 22 (44.9) | 16 (32.7) | 26 (53.1) | 21 (42.9) | 5 (10.2) | 0 |
Constipation | 14 (28.6) | 12 (24.5) | 2 (4.1) | 0 | 3 (6.1) | 2 (4.1) | 1 (2.0) | 0 |
Vomiting | 14 (28.6) | 10 (20.4) | 3 (6.1) | 1 (2.0) | 4 (8.2) | 4 (8.2) | 0 | 0 |
Fatigue | 12 (24.5) | 8 (16.3) | 2 (4.1) | 2 (4.1) | 2 (4.1) | 2 (4.1) | 0 | 0 |
Abdominal pain | 11 (22.4) | 8 (16.3) | 3 (6.1) | 0 | 2 (4.1) | 2 (4.1) | 0 | 0 |
Nausea | 11 (22.4) | 9 (18.4) | 1 (2.0) | 1 (2.0) | 2 (4.1) | 2 (4.1) | 0 | 0 |
Arthralgia | 10 (20.4) | 7 (14.3) | 3 (6.1) | 0 | 4 (8.2) | 3 (6.1) | 1 (2.0) | 0 |
Asthenia | 10 (20.4) | 7 (14.3) | 3 (6.1) | 0 | 2 (4.1) | 2 (4.1) | 0 | 0 |
Diarrhea | 8 (16.3) | 5 (10.2) | 2 (4.1) | 1 (2.0) | 1 (2.0) | 1 (2.0) | 0 | 0 |
Dyspnea | 8 (16.3) | 6 (12.2) | 2 (4.1) | 0 | 1 (2.0) | 1 (2.0) | 0 | 0 |
Decreased appetite | 7 (14.3) | 5 (10.2) | 2 (4.1) | 0 | 2 (4.1) | 2 (4.1) | 0 | 0 |
Hot flush | 7 (14.3) | 5 (10.2) | 2 (4.1) | 0 | 5 (10.2) | 5 (10.2) | 0 | 0 |
Abdominal pain upper | 6 (12.2) | 2 (4.1) | 4 (8.2) | 0 | 1 (2.0) | 1 (2.0) | 0 | 0 |
Back pain | 5 (10.2) | 3 (6.1) | 2 (4.1) | 0 | 0 | 0 | 0 | 0 |
Urinary tract infection | 5 (10.2) | 0 | 5 (10.2) | 0 | 1 (2.0) | 0 | 1 (2.0) | 0 |
Cough | 4 (8.2) | 4 (8.2) | 0 | 0 | 1 (2.0) | 1 (2.0) | 0 | 0 |
Gastroesophageal reflux disease | 4 (8.2) | 4 (8.2) | 0 | 0 | 3 (6.1) | 3 (6.1) | 0 | 0 |
Hypertension | 4 (8.2) | 0 | 4 (8.2) | 0 | 1 (2.0) | 0 | 1 (2.0) | 0 |
Pyrexia | 4 (8.2) | 3 (6.1) | 1 (2.0) | 0 | 0 | 0 | 0 | 0 |
ALT increased | 3 (6.1) | 0 | 0 | 3 (6.1) | 0 | 0 | 0 | 0 |
AST increased | 3 (6.1) | 0 | 0 | 3 (6.1) | 0 | 0 | 0 | 0 |
Depression | 3 (6.1) | 3 (6.1) | 0 | 0 | 2 (4.1) | 2 (4.1) | 0 | 0 |
Dry skin | 3 (6.1) | 2 (4.1) | 1 (2.0) | 0 | 1 (2.0) | 1 (2.0) | 0 | 0 |
Edema peripheral | 3 (6.1) | 3 (6.1) | 0 | 0 | 1 (2.0) | 1 (2.0) | 0 | 0 |
Headache | 3 (6.1) | 3 (6.1) | 0 | 0 | 0 | 0 | 0 | 0 |
Nasopharyngitis | 3 (6.1) | 3 (6.1) | 0 | 0 | 0 | 0 | 0 | 0 |
Pain in extremity | 3 (6.1) | 2 (4.1) | 1 (2.0) | 0 | 0 | 0 | 0 | |
Paresthesia | 3 (6.1) | 3 (6.1) | 0 | 0 | 1 (2.0) | 1 (2.0) | 0 | 0 |
Rhinitis allergic | 3 (6.1) | 2 (4.1) | 1 (2.0) | 0 | 0 | 0 | 0 | 0 |
