Examples of such events are: • Angio- oedema not severe enough to require intubation but requiring iv. hydrocortisone tr eatment • Hepatotoxicity caused by paracetamol (acetaminophen) overdose requiring treatment with N -acetylcysteine • Intensive treatment in an emergency room or at home for allergic bronchospasm • Blood dyscrasias (e.g. neutropenia or anaemia requiring blood transfusion, etc) or convulsions that do not result in hospitalisation • Development of drug dependency or drug abuse CT TG01 -01 Version v 10.0 27 June 2018 Confidential 86 / 87 APPENDIX II: FURTHER GUIDANCE ON THE ASSESSMENT OF CAUSALITY The following factors should be considered when deciding if there is a “reasonable possibility” that an adverse event (AE) may have been caused by the investigational product.