Definitions
congenital anomaly/birth, death.5, Ischaemic bowel, Abdominal pain, disability/incapacity, Nausea, hypoglycaemia
ADVERSE EVENT, ACUTE OBSTRUCTION, ANAPHYLACTIC REACTION, DISEASE, EVENT, COMPLICATION, HYPERSENSITIVITY REACTION, HYPOGLYCAEMIA, ELECTROLYTE DISTURBANCE, HYPOGLYCAEMIA

Adverse Events are any untoward medical occurrence or effect in a patient participating in the trial, which does not necessarily have a causal relationship with trial treatment. An Adverse Event can therefore be any unfavourable symptom or disease temporally associated with the use of the trial treatment, whether or not it is related to the allocated trial treatment.Serious Adverse Events (SAEs) are AEs thatResult in death;Are life-threatening;Require in-patient hospitalisation or prolongation of existing hospitalisation;Result in persistent or significant disability/incapacity; orResult in a congenital anomaly/birth defectAll AEs were graded for severity:0. None: indicates no event or complication.1. Mild: complication results in only temporary harm and does not require clinical treatment.2. Moderate: complication requires clinical treatment but does not result in significant prolongation of hospital stay. Does not usually result in permanent harm and where this does occur the harm does not cause functional limitation to the patient.3. Severe: complication requires clinical treatment and results in significant prolongation of hospital stay, permanent functional limitation.4. Life-threatening: complication that may lead to death.5. Fatal: indicates that the patient died as a direct result of the complication/adverse event.
Abdominal distension – new, clinically significant change in appearance. Considered severe if acute obstruction.Abdominal pain – new, localised to abdomen and requiring more than just simple analgesia. Considered severe if not controlled with opiates.Electrolyte disturbance – new change that is clinically significant requiring active monitoring or treatment.Hypersensitivity reaction (anaphylactic reaction) – anaphylactic reaction.Hypoglycaemia – new, clinically significant hypoglycaemia requiring active monitoring or treatment.Ischaemic bowel – inferred on radiology or diagnosed visually, e.g. surgery or endoscopy.Nausea requiring treatment with anti-emetics; Vomiting – any episodeRegurgitation/aspiration – any episodes