Study: NCT02296346

Adverse event: "Jittery" Sensation during treatment
Serious: no
Organ System: General disorders
Notes: Subject reported sensation during infusion treatment; Ruled expected and related.
Frequency: 1 affected / 7 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Multiple subjects experienced urinary tract infections throughout the trial. All ruled expected and unlikely to be related.
Frequency: 3 affected / 7 at risk

Adverse event: Acute Cystitis without Hematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Ruled unexpected and unlikely to be related.
Frequency: 1 affected / 7 at risk

Adverse event: Knee Pain and Swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ruled unexpected and unlikely to be related.
Frequency: 1 affected / 7 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Ruled unexpected and unlikely to be related to trial.
Frequency: 1 affected / 7 at risk

Adverse event: Obstructive sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ruled unexpected and unlikely to be related in both subjects.
Frequency: 2 affected / 7 at risk

Adverse event: Mild Concussion
Serious: no
Organ System: Nervous system disorders
Notes: Ruled unexpected and unlikely to be related to trial.
Frequency: 1 affected / 7 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject experienced petechial rash on left chin; Ruled unexpected and unlikely to be related.
Frequency: 1 affected / 7 at risk

Adverse event: Infiltrated IV with treatment
Serious: no
Organ System: Vascular disorders
Notes: AE ruled expected and probably related.
Frequency: 1 affected / 7 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: In both subjects, infections were ruled expected and unlikely to be related.
Frequency: 2 affected / 7 at risk

Adverse event: Spinal Vertebral Lesions
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject noted to have 3 new spinal vertebral lesions on MRI. AE ruled expected and unlikely to be related.
Frequency: 1 affected / 7 at risk

Adverse event: Swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject experienced swelling in left calf. AE ruled unexpected and unlikely to be related.
Frequency: 1 affected / 7 at risk

Adverse event: Groin pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: AE ruled unexpected and unlikely to be related.
Frequency: 1 affected / 7 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: AE ruled expected and unlikely to be related.
Frequency: 1 affected / 7 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Stage 1 Pressure Ulcer in right foot. Ruled unexpected and unlikely to be related to trial
Frequency: 1 affected / 7 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ruled unexpected and unlikely to be related to trial
Frequency: 1 affected / 7 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Notes: Subject experienced reaction while receiving infusion of Rituximab. AE ruled expected and unlikely to be related to trial.
Frequency: 1 affected / 7 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject committed suicide shortly after withdrawing from the trial and experiencing disease progression/worsening of MS symptoms.
Frequency: 1 affected / 6 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject experienced pneumonia on 4 separate occasions; Ruled expected and unlikely to be attributed to trial.
Frequency: 1 affected / 6 at risk

Adverse event: Poor venous access
Serious: no
Organ System: Vascular disorders
Notes: Ruled Unexpected and Related.
Frequency: 1 affected / 6 at risk

Adverse event: Nocturnal Hypoxia (on PSG)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ruled unexpected and unlikely to be related.
Frequency: 1 affected / 6 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Ruled expected and probably related.
Frequency: 1 affected / 6 at risk

Adverse event: Low Hematocrit Requiring Transfusion of 1 unit PRBC
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Ruled unexpected and probably related.
Frequency: 1 affected / 6 at risk

Adverse event: Acute blood loss not requiring transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Ruled unexpected and probably related.
Frequency: 1 affected / 6 at risk

Adverse event: Catheter Line Crack
Serious: no
Organ System: Vascular disorders
Notes: Ruled unexpected and related.
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Ruled expected and probably related to treatment.
Frequency: 1 affected / 6 at risk

Adverse event: Mild Hives
Serious: no
Organ System: General disorders
Notes: Subject experienced mild hives during an MRI; Ruled unexpected and probably related.
Frequency: 1 affected / 6 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Ruled expected and probably related to trial.
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety Attacks
Serious: no
Organ System: Psychiatric disorders
Notes: Subject experienced intermittent anxiety attacks; Ruled unexpected and unlikely to be related to trial.
Frequency: 1 affected / 6 at risk