Study: NCT01257802

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Hot flush
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 6 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: worsening hypertension
Serious: no
Organ System: Renal and urinary disorders
Notes: this is felt to be secondary to the subject's fluid retention
Frequency: 1 affected / 6 at risk

Adverse event: bleeding at catheter site
Serious: no
Organ System: Surgical and medical procedures
Notes: hemodialysis catheter
Frequency: 1 affected / 6 at risk

Adverse event: menstrual spotting in between cycles
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hospitalization for items listed below:
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: joint pain, shortness of breath, hypertension Classified as musculoskeletal because as the array of systems were all related to her systemic lupus and a lupus related flare of disease
Frequency: 1 affected / 8 at risk

Adverse event: Hospitalization for items listed below
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: joint pain, nausea, and hypertension, classified as musculoskeletal because as the array of systems were all related to her systemic lupus and a lupus related flare of disease
Frequency: 1 affected / 8 at risk

Adverse event: leg striae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hot flush
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 8 at risk

Adverse event: hot and cold flashes
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: this was not a lupus related rash
Frequency: 1 affected / 8 at risk

Adverse event: increased sweating
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: 2 menstruations in 28 day cycle
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: pain in right hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: pain in right forearm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: stool incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Night sweats
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: bacterial overgrowth - GI related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: arthralgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: viral upper respiratory infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: edema of left calf, foot, and hand
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk