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 Common Uncommon Rare Unknown <1/10 to <1/10 to to ≥1/100 ≥1/1000 ≥1/10,000 <1/100 <1/1000 LNG-IUS Menstrual blood Depressed Altered mood Rash Increased blood spotting mood pressure Abdominal Uterine Oligomenorrhea Nervousness distension effects perforation are more Amenorrhea. Decreased Alopecia common libido Irregular Pruritus during the menstruation Headache Eczema first Migraine Pelvic months Abdominal pain inflammatory after the disease insertion, Nausea Endometritis and in Acne many will Cervicitis Hirsutism subside Oedema Back pain during prolonged Ovarian cysts use. Pelvic pain Dysmenorrhea Vaginal discharge Vulvovaginitis Breast tenderness Breast pain Weight gain Device expulsion DMPA Abdominal pain Depressed Vertigo Rectal Osteoporosis mood bleeding Abdominal Loss of bone Headaches Nervousness distension Breast lumps mineral density Decreased Pruritus Nipple Axillary swelling libido bleeding Pelvic Syncope Appetite inflammatory Tachycardia Abnormal increase disease Thirst bleeding Appetite Endometritis Hoarseness Galactorrhea decrease Oedema Paralysis Vaginal cysts
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
PT-protocol-v1.docx