Study: NCT02068820

Adverse event: Reproductive system complications
Serious: no
Organ System: Reproductive system and breast disorders
Notes: The following were effected:

Vaginal discharge Vasomotor symptoms Vaginal spotting Uterovaginal fistula Vaginal bleeding Pelvic abscess Vaginal leakage
Frequency: 2 affected / 20 at risk

Adverse event: Wound complications
Serious: no
Organ System: Surgical and medical procedures
Notes: The following were effected:

Wound dehiscence Wound seroma Left incisional drainage
Frequency: 2 affected / 20 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The following were effected:

Cellulitis
Frequency: 1 affected / 20 at risk

Adverse event: Cardiac complications
Serious: no
Organ System: Cardiac disorders
Notes: The following were effected:

Cardiac complications Tachycardia Atrial fibrillation
Frequency: 1 affected / 20 at risk

Adverse event: Vascular complications
Serious: no
Organ System: Vascular disorders
Notes: The following were effected:

Deep Vein Thrombosis
Frequency: 1 affected / 20 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: The following were effected:

Hypotension Hypertension Lymphedema Fever
Frequency: 1 affected / 20 at risk

Adverse event: Blood and lymphatic system complications
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: The following were effected:

Leukocytosis Anemia Thrombocytopenia Neutropenia Lymphatic ascites
Frequency: 2 affected / 20 at risk

Adverse event: Reproductive system complications
Serious: no
Organ System: Reproductive system and breast disorders
Notes: The following were effected:

Vaginal discharge Vasomotor symptoms Vaginal spotting Uterovaginal fistula Vaginal bleeding Pelvic abscess Vaginal leakage
Frequency: 7 affected / 180 at risk

Adverse event: Renal and urinary complications
Serious: no
Organ System: Renal and urinary disorders
Notes: The following were effected:

Acute renal insufficiency Polyuria Transient right hydronephrosis Urinary retention
Frequency: 4 affected / 180 at risk

Adverse event: Wound complications
Serious: no
Organ System: Surgical and medical procedures
Notes: The following were effected:

Wound dehiscence Wound seroma Left incisional drainage
Frequency: 1 affected / 180 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The following were effected:

Cellulitis
Frequency: 5 affected / 180 at risk

Adverse event: Respiratory, thoracic, and pulmonary complications
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The following were effected:

Pulmonary embolism Pleural effusions Pneumothorax
Frequency: 3 affected / 180 at risk

Adverse event: Cardiac complications
Serious: no
Organ System: Cardiac disorders
Notes: The following were effected:

Cardiac complications Tachycardia Atrial fibrillation
Frequency: 3 affected / 180 at risk

Adverse event: Gastrointestinal complications
Serious: no
Organ System: Gastrointestinal disorders
Notes: The following were effected:

Small bowel obstruction
Frequency: 3 affected / 180 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: The following were effected:

Hypotension Hypertension Lymphedema Fever
Frequency: 4 affected / 180 at risk

Adverse event: Blood and lymphatic system complications
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: The following were effected:

Leukocytosis Anemia Thrombocytopenia Neutropenia Lymphatic ascites
Frequency: 8 affected / 180 at risk