Study: NCT00176592

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: One Patient had normal pregnancy and delivery. Discontinued drug and no longer participated in the study. Other two patients terminated pregnancy.
Frequency: 2 affected / 36 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient experienced vomiting up all food and liquids; vertigo; severe gastroenteritis.
Frequency: 1 affected / 36 at risk

Adverse event: Loss of Hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Loss of hearing in left ear. Viral etiology. Treated by ENT.
Frequency: 1 affected / 36 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Notes: Patient found to have three aneurysms. Two were clipped and one wrapped, Mild left sided stroke suffered.
Frequency: 1 affected / 36 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Pain in right shoulder and leg. No foot sensation.
Frequency: 1 affected / 36 at risk

Adverse event: Pain/Burning at Injection Site
Serious: no
Organ System: General disorders
Notes: Complained of pain and/or burning at site of injection.
Frequency: 1 affected / 36 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Back pain, pain in upper arm/shoulder above IN, neck/shoulder pain, shoulder pain, and pain in left arm.
Frequency: 1 affected / 36 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: One Patient had normal pregnancy and delivery. Discontinued drug and no longer participated in the study. Other two patients terminated pregnancy.
Frequency: 1 affected / 39 at risk

Adverse event: Malignant Nodule in Lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient had a chest x-ray that showed nodule which was malignant. Patient had surgery to remove 1 lobe, right lung.
Frequency: 1 affected / 39 at risk

Adverse event: Pain near IV Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During MRI, pain near IV site (right forearm). Extravasated contrast/IV fluid.Swelling, decreased skin temp, increased paresthesias and skin turned black near site.
Frequency: 1 affected / 39 at risk

Adverse event: Myelitis
Serious: yes
Organ System: Nervous system disorders
Notes: Severe myelitis, bilateral leg weakness, dysesthesias, impaired balance.
Frequency: 1 affected / 39 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Pain behind right knee while walking and standing. Deep vein thrombosis and pulmonary embolism. Treated at hospital.
Frequency: 1 affected / 39 at risk

Adverse event: Balance Impairment
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Patient experienced balance impairment for about 1 week; MRI showed multiple enhancing lesions.
Frequency: 1 affected / 39 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastritis; nausea and vomiting; brainstem MS relapse.
Frequency: 1 affected / 39 at risk

Adverse event: Pain/Burning at Injection Site
Serious: no
Organ System: General disorders
Notes: Complained of pain and/or burning at site of injection.
Frequency: 2 affected / 39 at risk

Adverse event: Headache/Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Back pain, pain in upper arm/shoulder above IN, neck/shoulder pain, shoulder pain, and pain in left arm.
Frequency: 3 affected / 39 at risk