Table 4.
Treatment-emergent adverse events, regardless of causality
| No. (%) | ||||
|---|---|---|---|---|
| Olaratumab + Liposomal Doxorubicin (n = 62) | Liposomal Doxorubicin (n = 61) | |||
| All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
| Patients with any TEAE | 62 (100.0) | 37 (59.7) | 61 (100.0) | 40 (65.6) |
| Consolidated TEAE categorya | ||||
| Fatigueb | 38 (61.3) | 7 (11.3) | 38 (62.3) | 1 (1.6) |
| Mucositisc | 30 (48.4) | 0 | 28 (45.9) | 4 (6.6) |
| Rashd | 27 (43.5) | 3 (4.8) | 18 (29.5) | 5 (8.2) |
| Abdominal paine | 24 (38.7) | 2 (3.2) | 30 (49.2) | 8 (13.1) |
| Neutropeniaf | 20 (32.3) | 8 (12.9) | 13 (21.3) | 5 (8.2) |
| Neuropathyg | 12 (19.4) | 0 | 9 (14.8) | 0 |
| Hypomagnesemiah | 10 (16.1) | 0 | 6 (9.8) | 1 (1.6) |
| Preferred termsa,i | ||||
| Nausea | 35 (56.5) | 2 (3.2) | 39 (63.9) | 1 (1.6) |
| Constipation | 32 (51.6) | 2 (3.2) | 24 (39.3) | 0 |
| Vomiting | 21 (33.9) | 3 (4.8) | 20 (32.8) | 6 (9.8) |
| Palmar-plantar erythrodysesthesia syndrome | 21 (33.9) | 7 (11.3) | 27 (44.3) | 4 (6.6) |
| Diarrhea | 19 (30.6) | 2 (3.2) | 13 (21.3) | 0 |
| Back pain | 16 (25.8) | 1 (1.6) | 10 (16.4) | 1 (1.6) |
| Abdominal distension | 15 (24.2) | 2 (3.2) | 6 (9.8) | 2 (3.3) |
| Urinary tract infection | 15 (24.2) | 0 | 5 (8.2) | 2 (3.3) |
| Headache | 12 (19.4) | 0 | 7 (11.5) | 1 (1.6) |
| Anemia | 10 (16.1) | 3 (4.8) | 13 (21.3) | 1 (1.6) |
| Dysgeusia | 10 (16.1) | 0 | 3 (4.9) | 0 |
| Dehydration | 9 (14.5) | 3 (4.8) | 3 (4.9) | 2 (3.3) |
| Weight decreased | 8 (12.8) | 0 | 4 (6.6) | 0 |
| Proteinuria | 7 (11.3) | 0 | 2 (3.3) | 0 |
| Muscle spasms | 7 (11.3) | 0 | 3 (4.9) | 0 |
| Pain in extremity | 4 (6.5) | 0 | 9 (14.8) | 1 (1.6) |
| TEAE of special interest | ||||
| Infusion-related reactionsj | 6 (9.7) | 0 | 3 (4.9) | 0 |
| Any SAE | 27 (43.5) | 21 (33.9) | 23 (37.7) | 20 (32.8) |
| Discontinuation due to TEAE | 2 (3.2) | n.r. | 7 (11.5) | n.r. |
AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; n.r., not reported; SAE, serious adverse event; TEAE, treatment-emergent adverse event
aTEAEs occurring in ≥10% of patients (all grades) and with a ≥ 5% between-arm difference (all grades or grade ≥ 3)
bConsolidated term comprising the following synonymous MedDRA preferred terms: fatigue and asthenia
cConsolidated term comprising the following synonymous MedDRA preferred terms: aphthous stomatitis, mucosal inflammation, oropharyngeal pain, and stomatitis
dConsolidated term comprising the following synonymous MedDRA preferred terms: rash, rash follicular, rash generalized, rash macular, rash papular, rash pruritic, and rash pustular
eConsolidated term comprising the following synonymous MedDRA preferred terms: abdominal pain, abdominal pain lower, and abdominal pain upper
fConsolidated term comprising the following synonymous MedDRA preferred terms: leukopenia, neutropenia, neutrophil count decreased, and white blood cell count decreased
gConsolidated term comprising the following synonymous MedDRA preferred terms: hypoesthesia, neuropathy peripheral, paraesthesia, and peripheral sensory neuropathy
hConsolidated term comprising the following synonymous MedDRA preferred terms: blood magnesium decreased, hypomagnesemia, and magnesium deficiency
iOmits preferred terms that are included in consolidated categories
jInfusion-related reactions include a combination of specific preferred terms such as infusion-related reactions, anaphylaxis, and signs and symptoms such as flushing and itching