Table 3

All adverse reactions reported by patients on study

Adverse reactionPatients reporting reaction, nReaction probably related to R788
Drowsiness/fatigue No 
Diarrhea Yes 
SBP increased by > 10 mm Hg Yes 
Nausea Yes 
Headache Yes 
Weight gain > 5 kg Yes 
Vomiting Yes 
Abdominal pain Yes 
Shortness of breath No 
Dizziness No 
Constipation Yes 
ALT > 2× ULN Yes 
UTI No 
DVT No 
Chest tightness No 
Fever No 
Blurry vision No 
Lung hemangioma No 
LAD No 
Adverse reactionPatients reporting reaction, nReaction probably related to R788
Drowsiness/fatigue No 
Diarrhea Yes 
SBP increased by > 10 mm Hg Yes 
Nausea Yes 
Headache Yes 
Weight gain > 5 kg Yes 
Vomiting Yes 
Abdominal pain Yes 
Shortness of breath No 
Dizziness No 
Constipation Yes 
ALT > 2× ULN Yes 
UTI No 
DVT No 
Chest tightness No 
Fever No 
Blurry vision No 
Lung hemangioma No 
LAD No 

SBP indicates systolic blood pressure; ALT, alanine aminotransferase; ULN, upper limit of normal; UTI, urinary tract infection; DVT, deep vein thrombosis; and LAD, lymphadenopathy.

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