Table 3.

Adverse events and safety measures taken

ID	Diagnosis	Symptoms	AE grade	SAE	Relationship to study drug	Change of study intervention
1	Head ache	Headache	Mild	No	Unlikely	No change
2	Granuloma liver		Mild	No	Unlikely	No change
3	Headache	Headache	Mild	No	Unlikely	No change
3	Coprostasis	Abdominal pain	Mild	No	Unlikely	No change
5	Nausea	Nausea	Mild	No	Unlikely	No change
6	Jejunal obstruction	Abdominal pain	Severe	Yes	Unlikely	Withdrawn
6	Superficial surgical site infection		Moderate	No	Unlikely	No change
6	Deep surgical site infection		Moderate	No	Unlikely	No change
7	Headache	Headache	Mild	No	Unlikely	No change
8	Headache	Headache	Mild	No	Unlikely	No change
9	Nausea		Moderate	No	Unlikely	No change
9	Dizziness		Moderate	No	Unlikely	No change
9	Hematoma of abdominal wall near incision		Mild	No	Possible	No change
9	Low haemoglobin (72 g l–1)		Moderate	No	Possible	No change
9	Impaired oesophagogastral transit of gastrographin	Vomiting	Mild	No	Unlikely	No change

ID	Hospitalization prolonged	Drug therapy		Other action taken		Death	Life threatening
1	No	No		No
2	No	No		No
3	No	No		No
3	No	Yes	Metamizole	No
5	No	Yes	Metoclopramide	No
6	Yes	No		Yes	Reintervention	No	Yes
6	No	No		Yes	Vacuum therapy of laparatomy wound
6	No	No		Yes	Drainage
7	No	Yes	Paracetamol	No
8	No	Yes	Paracetamol	No
9	No	Yes	Metoclopramide	No
9	No	No		No
9	No	No		No
9	No	Yes	Ferrinject (ferric carboxymaltose)	No
9	No	No		No

AE, adverse event; SAE, serious adverse event