PRE-EMPT Trial Management Group Chief Investigator Professor Siladitya Bhattacharya Obstetrics & Gynaecology Professor or Reproductive Medicine School of Medicine and Dentistry University of Aberdeen Tel: 01224 438419 Email: s.bhattacharya@abdn.ac.uk Clinical Lead Investigators Dr Andrew Prentice University of Cambridge Email: ap128@cam.ac.uk Dr Andrew Horne University of Edinburgh Email: andrew.horne@ed.ac.uk Professor Hilary OD Critchley University of Edinburgh Email: hilary.critchley@ed.ac.uk Mr Kevin Cooper Aberdeen Royal Infirmary Email: kevin.cooper@nhs.net Professor Janesh K. Gupta Birmingham Women’s Hospital Email: j.k.gupta@bham.ac.uk Mr T Justin Clark Birmingham Women’s Hospital Email: Justin.Clark@bwhct.nhs.uk Mr Christian Becker University of Oxford Email: christian.becker@obs-gyn.ox.ac.uk Mr Ertan Saridogan University College London Hospitals Email: ertan.saridogan@uclh.nhs.uk Trial Coordination and Statistics Dr Jane Daniels Email: j.p.daniels@bham.ac.uk Laura Gennard Email: d.a.m.farrell@bham.ac.uk Lisa Leighton Email: l.j.leighton@bham.ac.uk Lee Middleton Email: l.j.middleton@bham.ac.uk Versha Cheed Email: v.cheed@bham.ac.uk Birmingham Clinical Trials Unit University of Birmingham Health Economics Professor Tracy Roberts Email: t.e.roberts@bham.ac.uk Sabina Sanghera Email: s.sanghera@bham.ac.uk University of Birmingham Qualitative Research Professor Elaine Denny Birmingham City University Email: elaine.denny@bcu.ac.uk Dr Georgina Louise Jones University of Sheffield Email: g.j.jones@sheffield.ac.uk Independent Trial Steering Committee For independent oversight Chair: tbc Data Monitoring and Ethics Committee For interim analysis and response to specific concerns Chair: tbc
A: PRE-EMPT- Toxicities/side-effects that have previously occurred and are listed in the LNG-IUS SMPC do not have to be reported to the MHRA. If the outcome of the side-effect is serious, the SAE form should be completed. Any SAE not described below, i.e. a serious toxicity that is unexpected, and believed to be related to study treatment, will be reported as a SUSAR (see section 6.0 of the protocol). Trial drug Very common <1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1000 to <1/100 Rare ≥1/10,000 to <1/1000 Unknown LNG-IUS effects are more common during the first months after the insertion, and in many will subside during prolonged use. Menstrual blood spotting Oligomenorrhea Amenorrhea. Irregular menstruation Depressed mood Nervousness Decreased libido Headache Migraine Abdominal pain Nausea Acne Hirsutism Back pain Ovarian cysts Pelvic pain Dysmenorrhea Vaginal discharge Vulvovaginitis Breast tenderness Breast pain Weight gain Device expulsion Altered mood Abdominal distension Alopecia Pruritus Eczema Pelvic inflammatory disease Endometritis Cervicitis Oedema Rash Uterine perforation Increased blood pressure DMPA Abdominal pain Headaches Depressed mood Nervousness Decreased libido Appetite increase Appetite decrease Vertigo Abdominal distension Pruritus Pelvic inflammatory disease Endometritis Oedema Rectal bleeding Breast lumps Nipple bleeding Tachycardia Thirst Hoarseness Paralysis Osteoporosis Loss of bone mineral density Axillary swelling Syncope Abnormal bleeding Galactorrhea Vaginal cysts