at least one dose of BLINCYTO. The median age of the study population was 37 years (range: 18 to 79 years), 63% were male, 79% were White, 3% were Asian, and 3% were Black or African American.
The most common adverse reactions (≥ 20%) were pyrexia (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia (23%), and constipation (20%).
Serious adverse reactions were reported in 65% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, pneumonia, sepsis, neutropenia, device-related infection, tremor, encephalopathy, infection, overdose, confusion, Staphylococcal bacteremia, and headache.
Adverse reactions of Grade 3 or higher were reported in 80% of patients. Discontinuation of therapy due to adverse reactions occurred in 18% of patients treated with BLINCYTO. The adverse reactions reported most frequently as the reason for discontinuation of treatment included encephalopathy and sepsis. Fatal adverse events occurred in 15% of patients. The majority of these events were infections. No fatal adverse events occurred on treatment among patients in remission.
The adverse reactions with ≥ 10% incidence for any grade or ≥ 5% incidence for Grade 3 or higher are summarized in Table 2.
Table 2. Adverse Reactions With ≥ 10% Incidence for Any Grade or ≥ 5% Incidence for Grade 3 or Higher (N = 212) Adverse Reaction
Any Grade*
(%)
Grade 3 or
Higher*
(%)
* Grading based on NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
† Diarrhea includes the following terms: colitis, diarrhea, enteritis, and neutropenic colitis.
‡ Tremor includes the following terms: resting tremor and tremor. § Dyspnea includes the following terms: acute respiratory failure, bronchial hyperactivity, bronchospasm, dyspnea, dyspnea exertional, respiratory distress, respiratory failure, and wheezing.
¶ Rash includes the following terms: erythema, rash, erythematous rash, generalized rash, macular rash, maculo-papular rash, papular rash, and vesicular rash.
Blood and lymphatic system disorders
Febrile neutropenia
Anemia
Neutropenia
Thrombocytopenia
Leukopenia
25
18
16
11
9
23
13
15
8
8
Gastrointestinal disorders
Nausea
Constipation
Diarrhea†
Abdominal pain
Vomiting
25
20
20
15
13
0
< 1
1
2
0
General disorders and administration site conditions
Pyrexia
Peripheral edema
Fatigue
Chills
Chest pain
62
25
17
15
11
7
< 1
1
0
1
Immune syst |
