Study: NCT01388907

Adverse event: Miscarriage on first quarter/SAE due to deliveries
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 33 at risk

Adverse event: ovarian hyperstimulation and in vitro fertilization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 33 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Anemia due to pre- and post-operative bleeding (metrorragia)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Parietal hematoma requiring Hospitalization
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal pain and digestive disorders/SAE due to deliveries
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Compress removal/Small intestine's adhesions, requiring hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 33 at risk

Adverse event: Calf Pain (negative Doppler for phlebitis)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Varicella AND Parietal hematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Continuous pelvic pain AND Mild separation of the parietal scar
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 33 at risk

Adverse event: Thoracic Pain (negative angioscanner)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Keloid laparoscopic scar
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: 38.8°C Fever
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Submucosal myoma
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 33 at risk

Adverse event: Parietal hematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Fever (38.5°C)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Submucosal myoma requiring re-intervention
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: Intra-uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: Superficial injury of sigmoid during coelioscopy
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Fever during 48-hours post-surgery
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Hemorrhagic uterus during myomectomy
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: Submucosal myoma
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: Metrorragia due to uterine cavity opening.
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: Parietal hematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hematoma on umbilical scar
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk