Study: NCT00631852

Adverse event: hemorrhage/ bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Pt had episode of increased bleeding in JP drain after mastectomy + reconstruction. Output \>250mL over a 2 hours on post-op day 5. Pt returned to OR on post-op day 6 for evacuation of hematoma \& discharged post op day 7. Resolved by post-op day 12.
Frequency: 1 affected / 16 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain at surgical incision site
Frequency: 15 affected / 16 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: numbness in arm at surgical drain site.
Frequency: 1 affected / 16 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Notes: dizziness ann syncope
Frequency: 1 affected / 16 at risk

Adverse event: decreased sensation of digits
Serious: no
Organ System: Nervous system disorders
Notes: lack of feeling in 2nd and 3rd digits bilaterally.
Frequency: 1 affected / 16 at risk

Adverse event: coolness in digits
Serious: no
Organ System: Nervous system disorders
Notes: Coolness/ feeling cold in 2nd and 3rd digits bilaterally.
Frequency: 1 affected / 16 at risk

Adverse event: Floater in eye
Serious: no
Organ System: Eye disorders
Notes: Visual sensation of a "floater" in right eye.
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: headache
Frequency: 7 affected / 16 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: pain in back.
Frequency: 1 affected / 16 at risk

Adverse event: soar throat
Serious: no
Organ System: Gastrointestinal disorders
Notes: pain in throat.
Frequency: 1 affected / 16 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Injection site reaction resulting in airway obstruction from IV morphine sulfphate.
Frequency: 1 affected / 16 at risk

Adverse event: decreased oxygen saturation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: O2 saturation dropped below 90%.
Frequency: 2 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: shortness of breath as perceived by patient.
Frequency: 1 affected / 16 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Edema of upper extremity following surgery.
Frequency: 3 affected / 16 at risk

Adverse event: Oedema
Serious: no
Organ System: Surgical and medical procedures
Notes: Edema at surgical and reconstructive sites.
Frequency: 2 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Feeling of tiredness.
Frequency: 3 affected / 16 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: General disorders
Notes: Feeling of excessive energy and need to keep moving.
Frequency: 2 affected / 16 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hiccups
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: hot flash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk