Study: NCT00537290

Adverse event: Antiepileptic drug adjustment (history of seizure disorder)
Serious: yes
Organ System: Nervous system disorders
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 1 affected / 19 at risk

Adverse event: Brain surgery (history of seizure disorder)
Serious: yes
Organ System: Nervous system disorders
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 1 affected / 19 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 1 affected / 19 at risk

Adverse event: New-onset focal motor seizure due to previous stroke
Serious: yes
Organ System: Nervous system disorders
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 1 affected / 19 at risk

Adverse event: 48-hour EEG monitoring and new-onset partial sensory seizure
Serious: yes
Organ System: Nervous system disorders
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 1 affected / 19 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 2 affected / 19 at risk

Adverse event: Viral gastroenteritis/dehydration/cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 1 affected / 19 at risk

Adverse event: Recurrent deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 1 affected / 19 at risk

Adverse event: Post-phlebitic syndrome
Serious: yes
Organ System: Vascular disorders
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 1 affected / 19 at risk

Adverse event: Multifocal atrial tachycardia due to resolving pneumonia
Serious: yes
Organ System: Cardiac disorders
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 1 affected / 19 at risk

Adverse event: Allergy-Trimethoprim/sulfamethoxazole treatment
Serious: yes
Organ System: Immune system disorders
Notes: A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Frequency: 1 affected / 19 at risk

Adverse event: Chest pain with fever, chills, and low back pain
Serious: no
Organ System: Cardiac disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Transient chest pressure
Serious: no
Organ System: Cardiac disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 3 affected / 19 at risk

Adverse event: Diffuse severe erythematous rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Transient palpitations (recurrence)
Serious: no
Organ System: Cardiac disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Deep vein thrombosis (recurrence)
Serious: no
Organ System: Vascular disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Raynaud's phenomenon (new)
Serious: no
Organ System: Vascular disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Rash (diffuse) within 1 week of rituximab infusion (new)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Rash (local) within 1 week of rituximab infusion (new)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Rash (local) due to nail glue allergy (new)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Gastrointestinal reflux disease (new)
Serious: no
Organ System: Gastrointestinal disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Epistaxis (recurrence)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 6 affected / 19 at risk

Adverse event: Tonsillitis, otitis, sinusitis
Serious: no
Organ System: Infections and infestations
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 3 affected / 19 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 3 affected / 19 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 2 affected / 19 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 2 affected / 19 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Herpes zoster infection within 2 weeks of rituximab infusion (new)
Serious: no
Organ System: Infections and infestations
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Herpes zoster infection while noncompliant with prophylaxis (recurrence)
Serious: no
Organ System: Infections and infestations
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Arthralgia (local) (new)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 2 affected / 19 at risk

Adverse event: Arthritis (diffuse) within 1 week of the infusion (new)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 2 affected / 19 at risk

Adverse event: Arthralgia (diffuse) within 2 weeks of the infusion (new)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Arthralgia (local) (recurrence)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Carpal tunnel syndrome (recurrence)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Gout flare (recurrence)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Shoulder dislocation (new)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Elbow incidental MRI metallic artifact finding (new)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Seizures (history of partially controlled seizures) (recurrence)
Serious: no
Organ System: Nervous system disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Depression (new)
Serious: no
Organ System: Psychiatric disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Migraine (new)
Serious: no
Organ System: Nervous system disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk

Adverse event: Headache (severe, transient) (new)
Serious: no
Organ System: Nervous system disorders
Notes: An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
Frequency: 1 affected / 19 at risk