Category of TEAE | Safety analysis set 2 during part 2 of the studya | Safety analysis set 2 during part 2 and/or part 3 of the studya | ||||
---|---|---|---|---|---|---|
CC (n = 53) | LC (n = 51) | LC (n = 52) | ||||
n (%) | m | n (%) | m | n (%) | m | |
Any | 28 (52.8) | 63 | 28 (54.9) | 56 | 41 (78.8) | 124 |
Serious | 9 (17.0) | 10 | 11 (21.6) | 17 | 19 (36.5) | 29 |
Related to study drug | 10 (18.9) | 16 | 8 (15.7) | 14 | 12 (23.1) | 21 |
Leading to study withdrawal | 2 (3.8) | 2 | 3 (5.9) | 6 | 3 (5.8) | 6 |
Leading to death | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
TEAEs occurring in ≥3% of patients in ≥1 treatment arm | ||||||
Blood and lymphatic system disorders | ||||||
Anemia | 0 (0.0) | 0 | 0 (0.0) | 0 | 2 (3.8) | 2 |
Gastrointestinal disorders | ||||||
Vomitingb | 1 (1.9) | 2 | 2 (3.9) | 2 | 6 (11.5) | 7 |
Nauseac | 2 (3.8) | 2 | 2 (3.9) | 3 | 4 (7.7) | 6 |
Abdominal pain | 1 (1.9) | 1 | 0 (0.0) | 0 | 2 (3.8) | 3 |
Diarrhea | 2 (3.8) | 3 | 0 (0.0) | 0 | 0 (0.0) | 0 |
General disorders and administration site conditions | ||||||
Pyrexia | 0 (0.0) | 0 | 1 (2.0) | 1 | 2 (3.8) | 3 |
Infections and infestations | ||||||
Peritonitisd | 0 (0.0) | 0 | 3 (5.9) | 4 | 5 (9.6) | 6 |
Upper respiratory tract infection | 0 (0.0) | 0 | 3 (5.9) | 3 | 5 (9.6) | 5 |
Nasopharyngitis | 2 (3.8) | 2 | 0 (0.0) | 0 | 2 (3.8) | 3 |
Device related infection | 0 (0.0) | 0 | 2 (3.9) | 2 | 2 (3.8) | 3 |
Respiratory tract infection | 3 (5.7) | 5 | 0 (0.0) | 0 | 2 (3.8) | 2 |
Hordeolum | 0 (0.0) | 0 | 1 (2.0) | 1 | 2 (3.8) | 2 |
Influenza | 2 (3.8) | 2 | 0 (0.0) | 0 | 1 (1.9) | 1 |
Metabolism and nutrition disorders | ||||||
Hypercalcemiae | 9 (17.0) | 9 | 4 (7.8) | 4 | 5 (9.6) | 9 |
Hypocalcemia | 3 (5.7) | 3 | 1 (2.0) | 1 | 3 (5.8) | 6 |
Hyperkalemiae | 1 (1.9) | 1 | 0 (0.0) | 0 | 2 (3.8) | 2 |
Hyperphosphatemia | 2 (3.8) | 2 | 0 (0.0) | 0 | 0 (0.0) | 0 |
Hypophosphatemia | 3 (5.7) | 4 | 4 (7.8) | 5 | 6 (11.5) | 10 |
Vascular disorders | ||||||
Hypotension | 0 (0.0) | 0 | 2 (3.9) | 4 | 2 (3.8) | 4 |
Hypertensiond | 3 (5.7) | 3 | 1 (2.0) | 1 | 1 (1.9) | 1 |