Table 2.
TEAEs Occurring in ≥ 5% of Patients (all doses of NEOD001)
| AEs (Preferred Term) (≥ 5% Total Incidence) | All Patients (N = 27) | |
|---|---|---|
| Total AEs | Grade 3 or Higher AEs | |
| Fatigue | 10 (37.0) | 0 |
| Upper respiratory tract infection | 7 (25.9) | 0 |
| Cough | 5 (18.5) | 0 |
| Dyspnea | 5 (18.5) | 0 |
| Headache | 4 (14.8) | 0 |
| Anemia | 4 (14.8) | 0 |
| Peripheral edema | 4 (14.8) | 0 |
| Increased blood creatinine | 4 (14.8) | 0 |
| Diarrhea | 3 (11.1) | 0 |
| Edema | 3 (11.1) | 0 |
| Nausea | 3 (11.1) | 0 |
| Hyponatremia | 3 (11.1) | 2 (7.4) |
| Infusion site reaction | 2 (7.4) | 0 |
| Dyspnea exertional | 2 (7.4) | 0 |
| Oropharyngeal pain | 2 (7.4) | 0 |
| Productive cough | 2 (7.4) | 0 |
| Upper airway cough syndrome | 2 (7.4) | 0 |
| Wheezing | 2 (7.4) | 0 |
| Diverticulitis | 2 (7.4) | 1 (3.7) |
| Pneumonia | 2 (7.4) | 1 (3.7) |
| Arthralgia | 2 (7.4) | 0 |
| Back pain | 2 (7.4) | 0 |
| Dizziness | 2 (7.4) | 0 |
| Thrombocytopenia | 2 (7.4) | 0 |
| Depression | 2 (7.4) | 0 |
| Insomnia | 2 (7.4) | 0 |
NOTE. Ten patients (37.0%) reported a TEAE of grade 3 or higher, which included colitis, gastroenteritis, syncope, hypertriglyceridemia, fall, hypertension, noncardiac chest pain, diverticulitis, pneumonia, disseminated herpes zoster, and large diffuse B-cell lymphoma (grade 3 AE in one patient [3.7%] each), hyponatremia (grade 3 AE in two patients [7.4%]), intracardiac thrombus and spleen rupture (grade 4 AE in one patient [3.7%] each), and death (grade 5 in one patient [3.7%]).
Abbreviation: AE, adverse event; TEAE, treatment-emergent adverse event.