Study: NCT01147653

Adverse event: Painful urination and spotting 1 wk post infusion.
Serious: no
Organ System: Renal and urinary disorders
Notes: Seen by urgent care-abx started, stopped when cultures neg.
Frequency: 1 affected / 63 at risk

Adverse event: Admitted to ER with polyuria and polydipsia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Highest blood sugar 757. Received fluid and insulin- Diabetes Dx
Frequency: 1 affected / 63 at risk

Adverse event: Fever of 102 3 days post. Negative culture. No treatment-resolved in 3 days.
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Stomach pain from hydronephrotic dysplastic kidney
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: G tube fell out
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Pneumonia-hospitalized 10 days
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Fractured left foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Withdrawn during strep throat and sinus infection- EEG showed spikes , but no epileptiform activity
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Febrile seizure-isolated, not treated
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Fever 2 weeks post infusion-found to be viral laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Admitted to hospital- Flu
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Cough/Cold requiring antibiotics
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Pneumonia requiring antibiotics
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Developed cough and sats fell to 70 toward end of MRI- received blow by O2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Adverse behavioral rxn to Benadryl given infusion day- crying
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Diagnosed with Cockayne syndrome
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 63 at risk

Adverse event: Ear infection, cough, and fever 2 wks post infusion
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Fever for 2 days prior to infusion-given Tylenol
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Right foot fracture- cast required
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: High fever and febrile seizure associated with viral infection at home 2 weeks post infusion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: 2 seizures in interval- due to virus- on anti-seizure med
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Briefly hospitalized for bronchiolitis and dehydration- treated with rocephin and rehydration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Agitation and mild conjunctivitis of right eye following infusion.
Serious: no
Organ System: Immune system disorders
Notes: Returned to baseline after being given Benadryl.
Frequency: 1 affected / 63 at risk

Adverse event: Inhaler needed for respiratory wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Flushed in face with hypersensitivity rash on trunk
Serious: yes
Organ System: Endocrine disorders
Notes: Subject developed polydipsia, polyuria, and hyperglycemia the evening after infusion and was seen in the ED. Subject was diagnosed with type I diabetes (mother also has type I diabetes). This was reported to Medwatch.
Frequency: 1 affected / 63 at risk

Adverse event: Flushed in face with hypersensitivity rash on trunk. Sats 92%. No wheezing. Benadryl given
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Tactile temp overnight. Left otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Rash on abdomen and legs. No itching or welps. No treatment- resolved next day
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: G tube placement
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Diagnosed with walking pneumonia prior to final visit- on antibiotics
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk