Study: NCT00451204

Adverse event: MS Relapse (hospitalization)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 82 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 82 at risk

Adverse event: Migraine headache related eye pain
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Heart Failure/ pace maker implantation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 82 at risk

Adverse event: GA injection area abnormalities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 82 at risk

Adverse event: Irregular menses/ spotting
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 19 affected / 82 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 82 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 82 at risk

Adverse event: Depression/ Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 82 at risk

Adverse event: Menstrual flow amount increased
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 82 at risk

Adverse event: Nausea/ vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 82 at risk

Adverse event: GA injection systemic reaction (SOB, hot flashes)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 82 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 82 at risk

Adverse event: Arm/ leg numbness, tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 82 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 82 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 82 at risk

Adverse event: Vision problem (blurry, double)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 82 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 82 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 82 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 82 at risk

Adverse event: Heart palpitation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 82 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 82 at risk

Adverse event: Uterus, endometrial thickness > 8mm (ultrasound)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 24 affected / 82 at risk

Adverse event: Uterus, endometrial biopsies performed
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 82 at risk

Adverse event: Uterus, fibroibds (ultrasound)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 82 at risk

Adverse event: Fibrocystic disease on clinical exam
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 82 at risk

Adverse event: MS Relapse (hospitalization)
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 76 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Accidentally took other's drug
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 76 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 76 at risk

Adverse event: car accident related body numbness
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 76 at risk

Adverse event: Right Knee Replacemebt
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 76 at risk

Adverse event: GA injection area abnormalities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 76 at risk

Adverse event: Irregular menses/ spotting
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 76 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 76 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 76 at risk

Adverse event: Depression/ Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 76 at risk

Adverse event: Menstrual flow amount increased
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 76 at risk

Adverse event: Nausea/ vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 76 at risk

Adverse event: GA injection systemic reaction (SOB, hot flashes)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 76 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 76 at risk

Adverse event: Arm/ leg numbness, tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 76 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 76 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 76 at risk

Adverse event: Vision problem (blurry, double)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 76 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 76 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 76 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 76 at risk

Adverse event: Heart palpitation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 76 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 76 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 76 at risk

Adverse event: Uterus, endometrial thickness > 8mm (ultrasound)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 27 affected / 76 at risk

Adverse event: Uterus, endometrial biopsies performed
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 76 at risk

Adverse event: Uterus, fibroibds (ultrasound)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 76 at risk

Adverse event: Fibrocystic disease on clinical exam
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 76 at risk