Overview of TEAEs and most common TEAEs
| Patients with ≥1 . | Luspatercept (N = 96) . | Placebo (N = 49) . | Crossover∗ (N = 38) . |
|---|---|---|---|
| TEAE | 96 (100) | 48 (98.0) | 38 (100) |
| Grade ≥3 TEAE | 33 (34.4) | 15 (30.6) | 7 (18.4) |
| Serious TEAE | 23 (24.0) | 13 (26.5) | 3 (7.9) |
| TEAE leading to dose delay | 47 (49.0) | 11 (22.4) | 18 (47.4) |
| TEAE leading to dose reduction | 11 (11.5) | 0 | 2 (5.3) |
| TEAE leading to study drug discontinuation | 5 (5.2) | 4 (8.2) | 3 (7.9) |
| TEAE leading to death | 1 (1.0) | 0 | 0 |
| Treatment-related TEAE | 79 (82.3) | 18 (36.7) | 29 (76.3) |
| Treatment-related grade ≥3 TEAE | 12 (12.5) | 0 | 2 (5.3) |
| Treatment-related serious TEAE | 4 (4.2) | 0 | 1 (2.6) |
| Treatment-related TEAE leading to dose delay | 10 (10.4) | 0 | 3 (7.9) |
| Treatment-related TEAE leading to dose reduction | 11 (11.5) | 0 | 2 (5.3) |
| Treatment-related TEAE leading to study drug discontinuation | 4 (4.2) | 0 | 2 (5.3) |
| Treatment-related TEAE leading to death | 0 | 0 | 0 |
| TEAEs occurring in ≥10% of patients in either treatment arm | |||
| Headache | 44 (45.8) | 10 (20.4) | 10 (26.3) |
| Bone pain | 42 (43.8) | 3 (6.1) | 8 (21.1) |
| Back pain | 38 (39.6) | 6 (12.2) | 14 (36.8) |
| Arthralgia | 37 (38.5) | 8 (16.3) | 11 (28.9) |
| COVID-19 | 34 (35.4)† | 0 | 15 (39.5) |
| Pyrexia | 30 (31.3) | 9 (18.4) | 11 (28.9) |
| Pain in extremity | 29 (30.2) | 5 (10.2) | 6 (15.8) |
| Diarrhea | 25 (26.0) | 6 (12.2) | 5 (13.2) |
| Influenza-like illness | 25 (26.0) | 3 (6.1) | 2 (5.3) |
| Cough | 24 (25.0) | 1 (2.0) | 2 (5.3) |
| Upper respiratory tract infection | 23 (24.0) | 11 (22.4) | 1 (2.6) |
| Fatigue | 23 (24.0) | 10 (20.4) | 8 (21.1) |
| Prehypertension | 23 (24.0) | 7 (14.3) | 3 (7.9) |
| Oropharyngeal pain | 23 (24.0) | 6 (12.2) | 1 (2.6) |
| Pharyngitis | 21 (21.9) | 7 (14.3) | 1 (2.6) |
| Hypertension | 21 (21.9) | 1 (2.0) | 7 (18.4) |
| Asthenia | 19 (19.8) | 5 (10.2) | 0 |
| Dizziness | 19 (19.8) | 4 (8.2) | 3 (7.9) |
| Abdominal pain | 18 (18.8) | 6 (12.2) | 4 (10.5) |
| Dyspepsia | 18 (18.8) | 2 (4.1) | 3 (7.9) |
| Immunization reaction | 18 (18.8) | 0 | 5 (13.2) |
| Myalgia | 16 (16.7) | 5 (10.2) | 3 (7.9) |
| Influenza | 15 (15.6) | 5 (10.2) | 1 (2.6) |
| Abdominal pain upper | 15 (15.6) | 3 (6.1) | 5 (13.2) |
| Toothache | 15 (15.6) | 1 (2.0) | 0 |
| Nausea | 14 (14.6) | 6 (12.2) | 1 (2.6) |
| Iron overload | 14 (14.6) | 5 (10.2) | 0 |
| Insomnia | 14 (14.6) | 1 (2.0) | 1 (2.6) |
| Menstruation irregular | 13 (13.5) | 3 (6.1) | 2 (5.3) |
| Gastroenteritis | 12 (12.5) | 4 (8.2) | 2 (5.3) |
| Neck pain | 12 (12.5) | 2 (4.1) | 1 (2.6) |
| Epistaxis | 12 (12.5) | 1 (2.0) | 1 (2.6) |
| Vomiting | 11 (11.5) | 1 (2.0) | 1 (2.6) |
| Traumatic fracture | 10 (10.4) | 1 (2.0) | 0 |
| EMH | 10 (10.4) | 2 (4.1) | 2 (5.3) |
| Anxiety | 10 (10.4) | 0 | 1 (2.6) |
| Palpitations | 9 (9.4) | 6 (12.2) | 4 (10.5) |
| Rhinitis | 9 (9.4) | 6 (12.2) | 0 |
| Tonsillitis | 4 (4.2) | 6 (12.2) | 1 (2.6) |
| Patients with ≥1 . | Luspatercept (N = 96) . | Placebo (N = 49) . | Crossover∗ (N = 38) . |
|---|---|---|---|
| TEAE | 96 (100) | 48 (98.0) | 38 (100) |
| Grade ≥3 TEAE | 33 (34.4) | 15 (30.6) | 7 (18.4) |
| Serious TEAE | 23 (24.0) | 13 (26.5) | 3 (7.9) |
| TEAE leading to dose delay | 47 (49.0) | 11 (22.4) | 18 (47.4) |
| TEAE leading to dose reduction | 11 (11.5) | 0 | 2 (5.3) |
| TEAE leading to study drug discontinuation | 5 (5.2) | 4 (8.2) | 3 (7.9) |
| TEAE leading to death | 1 (1.0) | 0 | 0 |
| Treatment-related TEAE | 79 (82.3) | 18 (36.7) | 29 (76.3) |
| Treatment-related grade ≥3 TEAE | 12 (12.5) | 0 | 2 (5.3) |
| Treatment-related serious TEAE | 4 (4.2) | 0 | 1 (2.6) |
| Treatment-related TEAE leading to dose delay | 10 (10.4) | 0 | 3 (7.9) |
| Treatment-related TEAE leading to dose reduction | 11 (11.5) | 0 | 2 (5.3) |
| Treatment-related TEAE leading to study drug discontinuation | 4 (4.2) | 0 | 2 (5.3) |
| Treatment-related TEAE leading to death | 0 | 0 | 0 |
| TEAEs occurring in ≥10% of patients in either treatment arm | |||
| Headache | 44 (45.8) | 10 (20.4) | 10 (26.3) |
| Bone pain | 42 (43.8) | 3 (6.1) | 8 (21.1) |
| Back pain | 38 (39.6) | 6 (12.2) | 14 (36.8) |
| Arthralgia | 37 (38.5) | 8 (16.3) | 11 (28.9) |
| COVID-19 | 34 (35.4)† | 0 | 15 (39.5) |
| Pyrexia | 30 (31.3) | 9 (18.4) | 11 (28.9) |
| Pain in extremity | 29 (30.2) | 5 (10.2) | 6 (15.8) |
| Diarrhea | 25 (26.0) | 6 (12.2) | 5 (13.2) |
| Influenza-like illness | 25 (26.0) | 3 (6.1) | 2 (5.3) |
| Cough | 24 (25.0) | 1 (2.0) | 2 (5.3) |
| Upper respiratory tract infection | 23 (24.0) | 11 (22.4) | 1 (2.6) |
| Fatigue | 23 (24.0) | 10 (20.4) | 8 (21.1) |
| Prehypertension | 23 (24.0) | 7 (14.3) | 3 (7.9) |
| Oropharyngeal pain | 23 (24.0) | 6 (12.2) | 1 (2.6) |
| Pharyngitis | 21 (21.9) | 7 (14.3) | 1 (2.6) |
| Hypertension | 21 (21.9) | 1 (2.0) | 7 (18.4) |
| Asthenia | 19 (19.8) | 5 (10.2) | 0 |
| Dizziness | 19 (19.8) | 4 (8.2) | 3 (7.9) |
| Abdominal pain | 18 (18.8) | 6 (12.2) | 4 (10.5) |
| Dyspepsia | 18 (18.8) | 2 (4.1) | 3 (7.9) |
| Immunization reaction | 18 (18.8) | 0 | 5 (13.2) |
| Myalgia | 16 (16.7) | 5 (10.2) | 3 (7.9) |
| Influenza | 15 (15.6) | 5 (10.2) | 1 (2.6) |
| Abdominal pain upper | 15 (15.6) | 3 (6.1) | 5 (13.2) |
| Toothache | 15 (15.6) | 1 (2.0) | 0 |
| Nausea | 14 (14.6) | 6 (12.2) | 1 (2.6) |
| Iron overload | 14 (14.6) | 5 (10.2) | 0 |
| Insomnia | 14 (14.6) | 1 (2.0) | 1 (2.6) |
| Menstruation irregular | 13 (13.5) | 3 (6.1) | 2 (5.3) |
| Gastroenteritis | 12 (12.5) | 4 (8.2) | 2 (5.3) |
| Neck pain | 12 (12.5) | 2 (4.1) | 1 (2.6) |
| Epistaxis | 12 (12.5) | 1 (2.0) | 1 (2.6) |
| Vomiting | 11 (11.5) | 1 (2.0) | 1 (2.6) |
| Traumatic fracture | 10 (10.4) | 1 (2.0) | 0 |
| EMH | 10 (10.4) | 2 (4.1) | 2 (5.3) |
| Anxiety | 10 (10.4) | 0 | 1 (2.6) |
| Palpitations | 9 (9.4) | 6 (12.2) | 4 (10.5) |
| Rhinitis | 9 (9.4) | 6 (12.2) | 0 |
| Tonsillitis | 4 (4.2) | 6 (12.2) | 1 (2.6) |