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Table 2 Adverse events by grade in this phase-I study

From: BK-UM in patients with recurrent ovarian cancer or peritoneal cancer: a first-in-human phase-I study

 

Level 1

Level 2

Level 3

Patient no.

1

2

3

4

5

6

7

8

9

10

11

Appetite loss

2

2

         

General fatigue

        

2

  

Nausea

 

2

      

2

  

Vomiting

 

2

      

2

  

Ileus

 

2

   

3

     

Constipation

2

    

2

  

2

  

Diarrhea

     

2

     

Abdominal pain

 

2

   

2

     

Abdominal fullness

2

    

3

     

Intraabdominal bleeding

         

2

 

Lumbago

     

2

     

Headache

     

2

     

Fever

     

2c

2c

    

Dyspnea

        

2

  

Hematomaa

      

2

    

Erythema

        

2

  

Anemia

2

  

2

2

3

2

    

Elevation of ALT

      

2

    

Elevation of CRP

  

2

   

2c

2c

   

Hypoalbuminemia

2

 

2

        

Hypotensionb

       

3c

  

3c

  1. aHematoma in the inserted port
  2. bTransient hypotension accompanied by abdominal peritoneal irritation
  3. cAdverse events during the administration of BK-UM
  4. No asterisk in adverse events indicates events monitored during the observation period after the administration of BK-UM
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