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. 2013 Jun 20;3(3):323–338.

Table 3.

Treatment-emergent adverse events (TEAEs) attributed to rigosertib treatment-Clinical

Dose Levels Drug dose mg/m2 x 3 d #Pt Fatigue Infection Ileus/SBOe Muscle cramps/twitching/tremors Muscle weakness CNS symptoms
      Grade Grade Grade Grade Grade Grade
1-2 3 4 1-2 3 4 1-2 3 4 1-2 3 4 1-2 3 4 1-2 3 4
1 50 1 1                                  
2 100 2                                    
3 150 2         1c                          
4 250 3                                    
5 325 3                                    
6 400 4   1b   1 2d         1                
7 650 2                                    
8 850 3 2a                 2                
9 1,050 6   1a     1d                 1g   1h 1i  
10 1,375 8 5 1b     2d     3 1 3             1j  
11 1,700 1   1                 1f           1k  
Total   35                                    

Only toxicities which included Gr ≥3 are shown.

a

One of two patients with pre-existing fatigue symptom worsened;

b

pre-existing fatigue symptom worsened;

c

patient with MDS/AL hospitalized with febrile neutropenia;

d

including Port-A-Cath infection;

e

SBO, small bowel obstruction, all had gynecological neoplasms with pelvic surgery;

f

Patient #21;

g

Patient #13;

h

Hallucination;

i

Confusion, loss of recent memory;

j

Lethargy, confusion and delirium;

k

ataxia.

Additional clinical toxicities (all Gr 1-2) include pyrexia (Gr 1, n=2), epiphora (Gr 1, n=2), anorexia (Gr 1-2, n=4), vomiting (Gr 1, n=1), constipation (Gr 1-2, n=4), diarrhea (Gr 1-2, n=3), myalgia (Gr 1-2, n=4), dizziness (Gr 1-2, n=3), headache (Gr 2, n=2), and hypertension (Gr 1, n=4).