Adverse event (AE) profile of each treatment group
Subject | AE description | AE actions | AE severity | AE serious* | AE related to treatment arm | AE outcome |
A: non-operative treatment group | ||||||
009 | Fever-readmission | Further course of antibiotics given | Moderate | Yes* | Definitely | Resolved with sequelae |
PICC line insertion | Weekly follow up appointments in clinic | Moderate | No | Unrelated | Resolved | |
025 | Abdominal pain | – | Moderate | Yes* | Unrelated | Resolved |
Sore throat | Ibuprofen given | Mild | No | Unrelated | Resolved | |
103 | Abdominal pain | Antibiotics | Moderate | Yes* | Unlikely | Resolved |
Recurrent appendicitis | Appendicectomy | Severe | Yes* | Unlikely | Resolved | |
162 | Abdominal pain | Appendicectomy and hospital admission | Moderate | No | Definitely | Ongoing |
Fluid collection | Continued antibiotics. Already in hospital | Moderate | No | Definitely | Ongoing | |
179 | Abdominal pain | A&E attendance, bloods taken | Mild | No | Unrelated | Resolved |
233 | Abdominal pain | Appendicectomy and hospital admission | Moderate | No | Definitely | Resolved |
Recurrence of appendicitis | Appendicectomy | Moderate | No | Definitely | Resolved | |
266 | Recurrent appendicitis | Appendicectomy | Moderate | No | Definitely | Resolved |
002 | Abdominal pain | Admission to hospital | Mild | No | Probably | Resolved |
157 | Abdominal pain | – | Moderate | No | Possibly | Resolved |
049 | Abdominal pain | Advice given in A&E | Mild | No | Unrelated | Resolved |
089 | Patient visited GP surgery complaining of being sleepy for 2 weeks | None | Mild | No | Possibly | Ongoing |
Patient visited GP complaining of lethargy for 2 weeks | None | Mild | No | Possibly | Ongoing | |
Abdomen pain | Patient had appendicectomy | Moderate | No | Probably | Resolved | |
184 | Abdominal pain | Patient to be sent a clinic appointment | Mild | No | Unlikely | Ongoing |
185 | Rash over thighs | Patient given three doses of antihistamine | Mild | No | Unrelated | Resolved |
276 | Lethargic | Attended A+E. Discharged. Seen in clinic | Mild | No | Probably | Resolved |
289 | Generalised rash | Started antihistamines | Mild | No | Possibly | Resolved |
B: Appendicectomy | ||||||
014 | Abdominal pain | Intravenous antibiotics | Moderate | Yes | Possibly | Resolved |
Fever postop on readmission | NA | Mild | No | Possibly | Resolved | |
017 | Vomiting | Ultrasound scan | Moderate | Yes | Unlikely | Resolved |
123 | Headache | Paracetamol given | Mild | No | Unrelated | Resolved |
Abdominal pain | Blood test | Moderate | No | Possibly | Resolved | |
Intermittent vomiting | Blood test taken on 06/11/2017 was fine | Moderate | No | Possibly | Resolved | |
Headache | Ibuprofen, time off school | Mild | No | Possibly | Resolved | |
Sickness | Rest, off sick from school | – | No | Possibly | Resolved | |
Sickness | Surgical review | Mild | No | Unrelated | Resolved | |
Sickness | Off school | Mild | No | Unrelated | Resolved | |
264 | Fluid collection | Drain insertion and hospitalisation | Moderate | No | Unrelated | Resolved |
PICC line insertion | Hospitalisation | Moderate | No | Unrelated | Resolved | |
Drain insertion | Hospitalisation | Moderate | No | Unrelated | Resolved | |
040 | Localised intra-abdominal fluid collection | Treatment with intravenous antibiotics | Moderate | No | Possibly | Resolved |
167 | Inflamed wound site | Patient started oral flucloxacillin | Moderate | No | Definitely | Resolved with sequelae |
Wound dehiscence | Attended accident and emergency | Moderate | No | Definitely | Resolved | |
Diarrhoea | Telephone consultation with GP | Mild | No | Unlikely | Resolved with sequelae | |
Vomiting | Call to GP—stomach bug diagnosed | Mild | No | Unrelated | Resolved | |
Diarrhoea | Call to GP—stool sample | Mild | No | Unrelated | Resolved | |
Pharyngitis | Started oral amoxicillin | Mild | No | Unrelated | Resolved | |
245 | Wound infection | Started antibiotics | Moderate | No | Definitely | Resolved |
247 | Suture-related complication | Ultrasound and clinic appointment | Moderate | No | Probably | Resolved |
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.