Has a specific laboratory investigation confirmed the relationship? A “reasonable possibility” could be considered to exist for an AE where one or more of these factors exist. In contrast, there would not be a “reasonable possibility” of causality if none of the above criteria apply or where there is evidence of exposure and a reasonable time course but any dechallenge (if performed) is negative or ambiguous or there is another more likely cause of the AE. In difficult cases, other factors could be considered such as: • Is this a recognised feature of overdose of the drug? • Is there a known mechanism? Ambiguous cases should be considered as being a “reasonable possibility” of a causal relationship unl ess further evidence becomes available to refute this. Any events that are unequivocally because of progression of disease must not be reported as an adverse event . CT TG01 -01 Version v 10.0 27 June 2018 Confidential 87 / 87 APPENDIX III: PATIENT INSURANCE AND INDEMNITY Patients will be covered by an insurance set with Legemiddelansvarsforeningen. A certificate of insurance can be provided upon request.