Table 2

Adverse event (AE) profile of each treatment group

SubjectAE descriptionAE actionsAE severityAE serious*AE related to treatment armAE outcome
A: non-operative treatment group
009Fever-readmissionFurther course of antibiotics givenModerateYes*DefinitelyResolved with sequelae
PICC line insertionWeekly follow up appointments in clinicModerateNoUnrelatedResolved
025Abdominal painModerateYes*UnrelatedResolved
Sore throatIbuprofen givenMildNoUnrelatedResolved
103Abdominal painAntibioticsModerateYes*UnlikelyResolved
Recurrent appendicitisAppendicectomySevereYes*UnlikelyResolved
162Abdominal painAppendicectomy and hospital admissionModerateNoDefinitelyOngoing
Fluid collectionContinued antibiotics. Already in hospitalModerateNoDefinitelyOngoing
179Abdominal painA&E attendance, bloods takenMildNoUnrelatedResolved
233Abdominal painAppendicectomy and hospital admissionModerateNoDefinitelyResolved
Recurrence of appendicitisAppendicectomyModerateNoDefinitelyResolved
266Recurrent appendicitisAppendicectomyModerateNoDefinitelyResolved
002Abdominal painAdmission to hospitalMildNoProbablyResolved
157Abdominal painModerateNoPossiblyResolved
049Abdominal painAdvice given in A&EMildNoUnrelatedResolved
089Patient visited GP surgery complaining of being sleepy for 2 weeksNoneMildNoPossiblyOngoing
Patient visited GP complaining of lethargy for 2 weeksNoneMildNoPossiblyOngoing
Abdomen painPatient had appendicectomyModerateNoProbablyResolved
184Abdominal painPatient to be sent a clinic appointmentMildNoUnlikelyOngoing
185Rash over thighsPatient given three doses of antihistamineMildNoUnrelatedResolved
276LethargicAttended A+E. Discharged. Seen in clinicMildNoProbablyResolved
289Generalised rashStarted antihistaminesMildNo PossiblyResolved
B: Appendicectomy
014Abdominal painIntravenous antibioticsModerateYesPossiblyResolved
Fever postop on readmissionNAMildNoPossiblyResolved
017VomitingUltrasound scanModerateYesUnlikelyResolved
123HeadacheParacetamol givenMildNoUnrelatedResolved
Abdominal painBlood testModerateNoPossiblyResolved
Intermittent vomitingBlood test taken on 06/11/2017 was fineModerateNoPossiblyResolved
HeadacheIbuprofen, time off schoolMildNoPossiblyResolved
SicknessRest, off sick from schoolNoPossiblyResolved
SicknessSurgical reviewMildNoUnrelatedResolved
SicknessOff schoolMildNoUnrelatedResolved
264Fluid collectionDrain insertion and hospitalisationModerateNoUnrelatedResolved
PICC line insertionHospitalisationModerateNoUnrelatedResolved
Drain insertionHospitalisationModerateNoUnrelatedResolved
040Localised intra-abdominal fluid collectionTreatment with intravenous antibioticsModerateNoPossiblyResolved
167Inflamed wound sitePatient started oral flucloxacillinModerateNoDefinitelyResolved with sequelae
Wound dehiscenceAttended accident and emergencyModerateNoDefinitelyResolved
DiarrhoeaTelephone consultation with GPMildNoUnlikelyResolved with sequelae
VomitingCall to GP—stomach bug diagnosedMildNoUnrelatedResolved
DiarrhoeaCall to GP—stool sampleMildNoUnrelatedResolved
PharyngitisStarted oral amoxicillinMildNoUnrelatedResolved
245Wound infectionStarted antibioticsModerateNoDefinitelyResolved
247Suture-related complicationUltrasound and clinic appointmentModerateNoProbablyResolved
  • PICC, peripherally inserted central venous catheter; GP, general practitioner.

  • *Note that AEs that were reported as serious (SAEs) during the early months of the trial are included here as reported on the basis of standardised reporting terminology in RCTs in that they resulted in either prolongation of hospital stay, readmission to hospital or death. However, since these were all predictable and related more to the disease process rather than the study interventions, we subsequently reclassified these ‘expected’ SAEs as AEs in protocol amendment 1 10 April 2017. Thus, although similar AEs did occur beyond the first 2 months of the study, they were no longer reported as SAEs.