Table 2. Adverse Events by Treatment Occurring in ≥5% of Patients in the Doxorubicin Plus Olaratumab Group.
| Treatment-emergent adverse event, MedDRA preferred term | No. (%) | |||
|---|---|---|---|---|
| Doxorubicin + olaratumab (n = 257)a | Doxorubicin + placebo (n = 249)a | |||
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Nausea | 153 (59.5) | 7 (2.7) | 166 (66.7) | 6 (2.4) |
| Neutropeniab | 142 (55.3) | 119 (46.3) | 144 (57.8) | 122 (49.0) |
| Fatigueb | 139 (54.1) | 14 (5.4) | 147 (59.0) | 12 (4.8) |
| Alopecia | 112 (43.6) | 1 (0.4) | 124 (49.8) | 1 (0.4) |
| Anemiab | 110 (42.8) | 35 (13.6) | 113 (45.4) | 31 (12.4) |
| Musculoskeletal painb | 92 (35.8) | 5 (1.9) | 85 (34.1) | 3 (1.2) |
| Mucositisb | 89 (34.6) | 10 (3.9) | 101 (40.6) | 7 (2.8) |
| Leukopeniab | 81 (31.5) | 60 (23.3) | 78 (31.3) | 59 (23.7) |
| Constipation | 79 (30.7) | 1 (0.4) | 87 (34.9) | 2 (0.8) |
| Diarrhea | 74 (28.8) | 2 (0.8) | 75 (30.1) | 3 (1.2) |
| Decreased appetite | 71 (27.6) | 2 (0.8) | 92 (36.9) | 1 (0.4) |
| Vomiting | 63 (24.5) | 6 (2.3) | 69 (27.7) | 2 (0.8) |
| Thrombocytopeniab | 58 (22.6) | 24 (9.3) | 62 (24.9) | 21 (8.4) |
| Pyrexia | 48 (18.7) | 1 (0.4) | 46 (18.5) | 0 |
| Dyspnea | 46 (17.9) | 4 (1.6) | 36 (14.5) | 2 (0.8) |
| Abdominal painb | 45 (17.5) | 2 (0.8) | 53 (21.3) | 3 (1.2) |
| Dysgeusia | 45 (17.5) | 0 | 51 (20.5) | 0 |
| Febrile neutropenia | 45 (17.5) | 45 (17.5) | 41 (16.5) | 41 (16.5) |
| Cough | 43 (16.7) | 0 | 61 (24.5) | 1 (0.4) |
| Headache | 43 (16.7) | 2 (0.8) | 42 (16.9) | 0 |
| Edema | 34 (13.2) | 1 (0.4) | 23 (9.2) | 0 |
| Infusion-related reaction | 30 (11.7) | 6 (2.3) | 18 (7.2) | 2 (0.8) |
| Dyspepsia | 28 (10.9) | 0 | 29 (11.6) | 0 |
| Dizziness | 27 (10.5) | 1 (0.4) | 34 (13.7) | 0 |
| Upper respiratory tract infection | 25 (9.7) | 0 | 25 (10.0) | 1 (0.4) |
| Insomnia | 23 (8.9) | 0 | 30 (12.0) | 0 |
| Dry mouth | 22 (8.6) | 0 | 19 (7.6) | 0 |
| Alanine aminotransferase increased | 19 (7.4) | 3 (1.2) | 19 (7.6) | 4 (1.6) |
| Dehydration | 19 (7.4) | 2 (0.8) | 10 (4.0) | 2 (0.8) |
| Lymphopeniab | 19 (7.4) | 13 (5.1) | 17 (6.8) | 7 (2.8) |
| Urinary tract infection | 19 (7.4) | 5 (1.9) | 22 (8.8) | 1 (0.4) |
| γ-Glutamyltransferase increased | 18 (7.0) | 3 (1.2) | 17 (6.8) | 5 (2.0) |
| Neuropathyb | 17 (6.6) | 0 | 24 (9.6) | 1 (0.4) |
| Hypertensionb | 16 (6.2) | 5 (1.9) | 20 (8.0) | 6 (2.4) |
| Rashb | 16 (6.2) | 0 | 23 (9.2) | 0 |
| Oropharyngeal pain | 15 (5.8) | 0 | 18 (7.2) | 0 |
| Hypokalemiab | 14 (5.4) | 7 (2.7) | 12 (4.8) | 3 (1.2) |
| Pruritus | 14 (5.4) | 0 | 23 (9.2) | 0 |
Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event.
Common Terminology Criteria for Adverse Events version 4.0 was used to categorize TEAEs. Grades 1-5 were defined as: mild (grade 1), moderate (grade 2), severe or medically significant but not immediately life-threatening (grade 3), life-threatening (grade 4), and death related to TEAE (grade 5).
The following consolidated terms included terms presented in parentheses: abdominal pain (abdominal pain upper, abdominal pain lower); anemia (hemoglobin decreased); fatigue (asthenia); hypertension (hypertension); hypokalemia (blood potassium decreased); leukopenia (white blood cell count decreased); lymphopenia (lymphocyte count decreased); mucositis (stomatitis, oropharyngeal pain, mucosal inflammation); musculoskeletal pain (arthralgia, back pain, pain in extremity, muscle spasms, myalgia, bone pain, musculoskeletal chest pain, groin pain, neck pain, flank pain); neuropathy (paresthesia, neuropathy peripheral, peripheral sensory neuropathy, hypoesthesia); neutropenia (neutrophil count decreased); rash (rash, rash pruritic, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis bullous, rash generalized, rash macular); and thrombocytopenia (platelet count decreased).