Table 4.

Adverse Events

Grades 3/4 Adverse EventsAll Events Related to BTI-322
All RelatedOccurred With Dose 1 Occurred With Doses 2-10
Total no. of events4-150 156  44  39  
Body as a whole  13  74-151 7  
Cardiovascular  2  6 6  1  
Digestive 10  54-153 5  1  
Endocrine  0  0  0  
Heme/lymphatic  12  0  0  0  
Metabolic/nutritional 9  0  0  0  
Musculoskeletal  1  0  0  
Nervous system  4  14-155 1  0  
Repiratory system  6  64-154 6  0  
Cutaneous  3  1  0  
Special senses  0  0  0  0  
Urogenital  0  0  0  
Patients with ≥1 event  20  11  10 
Grades 3/4 Adverse EventsAll Events Related to BTI-322
All RelatedOccurred With Dose 1 Occurred With Doses 2-10
Total no. of events4-150 156  44  39  
Body as a whole  13  74-151 7  
Cardiovascular  2  6 6  1  
Digestive 10  54-153 5  1  
Endocrine  0  0  0  
Heme/lymphatic  12  0  0  0  
Metabolic/nutritional 9  0  0  0  
Musculoskeletal  1  0  0  
Nervous system  4  14-155 1  0  
Repiratory system  6  64-154 6  0  
Cutaneous  3  1  0  
Special senses  0  0  0  0  
Urogenital  0  0  0  
Patients with ≥1 event  20  11  10 
F4-150

This row reports the number of adverse events. Remainder of table reports numbers of patients in each category.

F4-151

Represents chills, fever, pruritus, flushing, pain.

Represents tachycardia, hypertension, hypotension, chest tightness.

F4-153

Represents nausea, vomiting, diarrhea, retching.

F4-155

Represents muscle cramps.

F4-154

Represents dyspnea, shortness of breath, hypoxia, wheezing.

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