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Table 2 List of subjects who were excluded from per protocol population

From: Prospective double-blind randomized study on the efficacy and safety of an n-3 fatty acid enriched intravenous fat emulsion in postsurgical gastric and colorectal cancer patients

Treatment

Reason for premature termination

Treatment duration

Study group (MCT/LCT/n-3)

Subject withdrew consent

1 day

 

Subject withdrew from the study due to without pathological evidence of colon cancer

5 days

 

Platelet at screening visit was 135 × 103/uL, < 150 × 103/uL

8 days

 

Subject used incorrect treatment (used MCT/LCT)

1 day

 

Patient experienced life-threatening SAE

7 days

 

Central venous catheter was removed due to infection

6 days

 

Too late for starting PN on day 1 at requested time

1 day

Control group (LCT/MCT)

AE: bilateral ankle pain

1 day

 

Subject withdrew consent

1 day

 

High fever, suspect central venous catheter infection

3 days

 

Subject withdrew consent

1 day

 

Acute bowel obstruction developed and patient underwent diversion colostomy and staged surgery

1 day

 

Patient experienced life-threatening SAE

7 days

 

Subject withdrew consent

1 day

  1. SAE: severe adverse event; AE: adverse event.