Study: NCT00619723

Adverse event: Inpatient hospitalization due to improperly healing bones from previous accident
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Event deemed as serious, unexpected and non-study related.
Frequency: 1 affected / 61 at risk

Adverse event: Sexual abuse
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Subject informed staff that she was raped. Subject denied physical injuries and was encouraged by study doctor to follow-up with primary care physician. Deemed serious, unexpected, and non-related to study medication.
Frequency: 1 affected / 61 at risk

Adverse event: Hairline fracture due to car accident
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject reported to ER after car accident. Hospitalized overnight and diagnosed with hairline fracture in ribs. Event deemed as serious, unexpected, and not related to study medication.
Frequency: 1 affected / 61 at risk

Adverse event: Hospitalization due to flu-like symptoms
Serious: yes
Organ System: General disorders
Notes: Subject hospitalized for 2 days due to flu-like symptoms. All tests at hospital came back negative and subject was released. Event deemed as serious, unexpected and unrelated to study medication.
Frequency: 1 affected / 61 at risk

Adverse event: Hospitalization due to pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject hospitalized for 5 days due to flu-like symptoms. In ER, subject diagnosed with pneumonia and treated with IV fluids and medication. Event deemed as serious, unexpected and unrelated to the study.
Frequency: 1 affected / 61 at risk

Adverse event: ER visit due to bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject went to ER due to bronchitis and was given antibiotics and released the same day.
Frequency: 1 affected / 61 at risk

Adverse event: Overnight hospitalization due to motor vehicle accident
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Released from hospital with severe bruising only. Deemed as a serious, unexpected and non-study related adverse event.
Frequency: 1 affected / 61 at risk

Adverse event: Abnormal EKG indicating previous heart damage
Serious: yes
Organ System: Cardiac disorders
Notes: Subject reported after receiving abnormal EKG on 2/18/10, that he had experienced chest pains after cocaine use in January (was not reported to study personnel at time). Blind was broken and subject sent to ER for workup.
Frequency: 1 affected / 61 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject reported suicidal ideation during study visit. Subject was assessed by study doctor and asked to agree to hospitalization. Subject refused and ran from office. Subject was contacted next day was deemed stable but withdrawn from study.
Frequency: 1 affected / 61 at risk

Adverse event: Hospitalization due to subacute pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Notes: Subject hospitalized for 4 days due to subacute pulmonary embolism and was there treated with Coumadin. Subject withdrawn from study and encouraged to follow-up with physician. Event deem serious, expected, and unrelated to study medication.
Frequency: 1 affected / 61 at risk

Adverse event: Labs results indicating Leukopenia and Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Subjects baseline blood lab results indicated abnormal white blood cell and platelet count. Labs were repeated and revealed similar result. Subject was withdrawn from study. Event deemed as serious, unexpected and unrelated to study medication.
Frequency: 1 affected / 61 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Ideation reported during study visit. Subject assessed by study personnel and created safety plan. Subject reported later in the day that ideation worsened and voluntarily committed himself to hospital. Serious, expected, unrelated to study.
Frequency: 1 affected / 61 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject experienced an ankle injury while mowing the lawn. Subject was assessed at the ER and given pain medication. Adverse event deemed as serious, unexpected, and unrelated to study medication.
Frequency: 1 affected / 61 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: General disorders
Notes: Subject reported to ER due to nausea, vomiting, faintness following drinking binge. At ER, subject deemed to have alcohol poisoning and given IV fluids and released same day. Event deemed to be serious, unexpected, and unrelated to study medication.
Frequency: 1 affected / 61 at risk

Adverse event: Superficial cuts and bruising due to attack
Serious: no
Organ System: General disorders
Notes: Subject reported being attacked by a man with a knife while returning home from work. Subject had two 1-inch superficial cuts on right hip and minor bruise to left upper chest. Event deemed non-serious, unexpected and non-study related.
Frequency: 1 affected / 61 at risk

Adverse event: Lacerations on face due to fall
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject reported slipping on water resulting in a fall on a glass vase, which led to multiple lacerations on face. Subject received stiches at ER and medication and sent home same day. Event deemed non-serious, unexpected and not related to study.
Frequency: 1 affected / 61 at risk

Adverse event: ER visit for breathing treatment
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject reported visiting ER for asthma breathing treatment. Subject not admitted to hospital and left after receiving breathing treatment. Event deemed non-serious, expected, and non-study related.
Frequency: 1 affected / 61 at risk

Adverse event: ER visit after slicing head on razor wire
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject received 9 staples in ER and released same day. Event deemed as non-serious, unexpected and non-study related.
Frequency: 1 affected / 61 at risk