Where an event is serious we would also ask if the event classifies as an Event of Special Interest (ESI).
Each ESI has a form that asks for a little more specific information about the event. It is helpful if an ESI arrives with the follow up form where the event is being reported; although we will also send these out to you if an ESI is reported on a clinical follow up without the corresponding form. We will also send out a form to the clinician if an ESI is reported by a participant.
If you are unable to complete an ESI due to lack of information please let us know so that we do not repeatedly contact you for information.
You can view and download any of our ESI forms below.
- Aplastic anaemia, Pancytopaenia, Serious Neutropenia (PDF, 129KB)
- Cerebrovascular accident (CVA) (PDF, 117KB)
- Serious Congestive heart failure (PDF, 145KB)
- Death (PDF, 261KB)
- Demyelination/Optic neuritis (PDF, 123KB)
- Lymphoproliferative Malignancy (PDF, 177KB)
- Malignancy including skin cancer/Bowen’s disease (PDF, 150KB)
- Myocardial Infarction/Serious Acute Coronary Syndrome (PDF, 168KB)
- Pregnancy (PDF, 57KB)
- Pulmonary Embolism (PDF, 134KB)
- Serious Infection (PDF, 213KB)
- Tuberculosis (PDF, 78KB)
- Serious Lupus/Lupus-like illness (PDF, 125KB)
- Hepatitis B Reactivation (PDF, 64KB)
- Serious Haemorrhage (PDF, 119KB)
- Serious skin reaction (eg Stevens Johnson syndrome, erythema multiforme, toxic epidermal necrosis) (PDF, 179KB)
- Serious lower GI ulcer/bleed/perforation (PDF, 115KB)
- Serious hepatic dysfunction/failure (PDF, 156KB)
- Serious Hypersensitivity Reaction (to the biologic/ biosimilar etc. used to treat Rheumatic disease) (PDF, 212KB)
If you experience any problems downloading an ESI form please let the office know and we can send you one via email or post.
Help with adverse events and ESIs
If you have any queries related to adverse events of ESIs, our pharmacovigilance team will be happy help you.
Tel: +44 (0)161 275 1613