Study: NCT00720122

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: These are unrelated and expected Serious Adverse Events and are due to the subjects' eating disorders.
Frequency: 4 affected / 28 at risk

Adverse event: Self-Injury
Serious: yes
Organ System: General disorders
Notes: This is an unrelated and expected Serious Adverse Event and is due to this subject's eating disorder and depression.
Frequency: 1 affected / 28 at risk

Adverse event: Itchiness at Injection Site
Serious: no
Organ System: General disorders
Frequency: 4 affected / 28 at risk

Adverse event: Facial Discoloration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: Subject fell while running for bus and suffered abrasions on left knee, shin, foot and hand.
Frequency: 1 affected / 28 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Notes: Subject ate hummus and felt ill afterwards.
Frequency: 1 affected / 28 at risk

Adverse event: Elevated Aspartate Aminotransferase
Serious: no
Organ System: General disorders
Frequency: 4 affected / 28 at risk

Adverse event: Severe Weight Loss
Serious: no
Organ System: General disorders
Notes: Subject exhibited severe weight loss at 9 month study visit and was discontinued from study due to refusal of inpatient treatment, for safety reasons.
Frequency: 1 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Subject stated it could be due to fatty food recently eaten.
Frequency: 1 affected / 28 at risk

Adverse event: Femoral Lymph Node Enlargement
Serious: no
Organ System: General disorders
Notes: Subject reported this, but enlargement was not found on exam by study nurse practitioner.
Frequency: 1 affected / 28 at risk

Adverse event: Contusion
Serious: no
Organ System: General disorders
Notes: One subject said this was due to her eating disorder and did not occur specifically at the injection site.
Frequency: 4 affected / 28 at risk

Adverse event: Cold with Mild Nose Bleed
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Lightheaded and Pale at Blood Draw
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Low Glucose Level
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Elevated Alanine Aminotransferase
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: General disorders
Notes: One subject said that this was due to her calcium supplements.
Frequency: 2 affected / 28 at risk

Adverse event: Achiness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Mild Itchiness to Bilateral Lower Extremities
Serious: no
Organ System: General disorders
Notes: The subject stated that this was most likely due to her recent change in soap powder.
Frequency: 1 affected / 28 at risk

Adverse event: Breast Bone Pain
Serious: no
Organ System: General disorders
Notes: The subject reported the pain lasting 5 -6 seconds and then resolving spontaneously.
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Coincided with the subject's recent Lexapro dose reduction.
Frequency: 2 affected / 28 at risk

Adverse event: Soreness at Injection Site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Low Potassium Level
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Increased Fatigue
Serious: no
Organ System: General disorders
Notes: Coincided with subject's increase in Prozac dosage.
Frequency: 1 affected / 28 at risk

Adverse event: Irritation at Injection Site
Serious: no
Organ System: General disorders
Frequency: 8 affected / 28 at risk

Adverse event: Papules at Injection Site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Burning Sensation at Injection Site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Prominent Thyroid
Serious: no
Organ System: General disorders
Notes: The subject did not have a goiter. Her thyroid stimulating hormone, thyroxine, and triiodothyronine labs were all normal.
Frequency: 1 affected / 28 at risk

Adverse event: Swelling of Bilateral Feet
Serious: no
Organ System: General disorders
Notes: Subject stated that this was probably due to warm weather.
Frequency: 1 affected / 28 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Notes: Subject stated that this was mostly likely due to warmer weather and the temperature being higher in her apartment building.
Frequency: 1 affected / 28 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: Subject had an ongoing history of back pain.
Frequency: 1 affected / 28 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: In subject's hand.
Frequency: 1 affected / 28 at risk

Adverse event: Hip Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: The subject had an ongoing history of headaches.
Frequency: 1 affected / 28 at risk

Adverse event: Erythema at Injection Site
Serious: no
Organ System: General disorders
Frequency: 4 affected / 28 at risk

Adverse event: Elevated Insulin-like Growth Factor 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Elevated Potassium Level
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Extremity Pain
Serious: no
Organ System: General disorders
Notes: Subject felt pain in hand and wrist after school and occasionally during school.
Frequency: 1 affected / 28 at risk

Adverse event: Occasional Bleeding at Injection Site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: Subject had a kidney stone that pass and was not tested. Subject followed up with a specialist and stopped taking calcium supplements.
Frequency: 1 affected / 28 at risk