ory distress, respiratory failure.
nRash includes rash, rash maculo-papular, rash papular, and rash pruritic.
Adverse Reaction All Grades
(%) Grades 3 or Higher
(%)
Blood and lymphatic system disorders
Febrile Neutropenia 37 37
Cardiac disorders
aTachycardia 26 4
Gastrointestinal disorders
Nausea 26 3
Diarrhea 26 1
Vomiting 26 1
Constipation 18 0
bAbdominal pain 16 3
General disorders and administration site conditions
Pyrexia 40 15
cFatigue 25 0
dEdema 21 1
Chills 10 0
ePain 18 3
Immune system disorders
Cytokine release syndrome 79 49
fHypogammaglobulinemia 43 7
Infections and infestations
Infections-pathogen unspecified 41 16
Viral infectious disorders 26 18
Bacterial infectious disorders 19 13
Fungal infectious disorders 13 7
Investigations
International normalized ratio increased 13 0
Metabolism and nutrition disorders
Decreased appetite 37 15
Fluid overload 10 7
Musculoskeletal and connective tissue disorders
Myalgia 15 0
Arthralgia 12 1
Back pain 10 3
Nervous system disorders
gHeadache 37 3
hEncephalopathy 34 10
Psychiatric disorders
iDelirium 21 4
Anxiety 13 3
jSleep disorders 10 0
Renal and urinary disorders
kAcute kidney injury 24 15
Respiratory, thoracic and mediastinal disorders
Hypoxia 24 18
lCough 21 0
mDyspnea 16 12
Pulmonary edema 16 10
Tachypnea 12 6
Pleural effusion 10 4
Nasal congestion 10 0
Skin and subcutaneous tissue disorders
nRash 16 1
Vascular disorders
Hypotension 31 22
Hypertension 19 6
aSpeech disorder includes aphasia and dysarthria.
bMotor dysfunction includes muscle spasms.
Additional important adverse reactions that did not meet the threshold criteria for inclusion in Table 2 were:
Blood and lymphatic system disorders: disseminated intravascular coagulation (9%), histiocytosis lymphocytic hemophagocytosis (7%), coagulopathy (6%), Grade 3 and Grade 4 hypofibrinogenemia with Grade 3 and 4 CRS (16%)
Cardiac Disorders: cardiac arrest (4%), cardiac failure (7%)
Gastrointestinal disorders: abdominal compartment syndrome (1%)&n