Study: NCT03988842

Adverse event: AKI and Anemia
Serious: yes
Organ System: Renal and urinary disorders
Notes: Kidney injury which he also has a long history of since 2015. Found to have anemia with a Hgb of 6.5 (He was given a unit of PRBCs and increased to 8.4). CT abdomen showed no major pathology. He did have fecal impaction at other hospital.
Frequency: 1 affected / 4 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient experienced respiratory failure and patient's family decided to make him DNR. He was placed in hospice facility and died a few days later.
Frequency: 1 affected / 4 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Found to have anemia with Hgb of 6.5. He was given a unit of PRBC's and increased 8.4.
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache after TNK administration
Frequency: 1 affected / 4 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Patient had pain in right eye that was sharp in nature. No loss of vision although patient stated that over the last 6 mo the patient felt slight decreased visual acuity bilaterally.
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Suspected bleed
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unknown drop of hemoglobin requiring transfusion
Frequency: 1 affected / 4 at risk

Adverse event: Bruising on chest
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Suspected bleed
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: seems to be related to ulceration on palate which was noted during hospital stay
Frequency: 1 affected / 4 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Suspected bleed
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: bleeding of gums from toothbrushing
Frequency: 1 affected / 4 at risk

Adverse event: worsening back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: worsening with bending down-- chest CTA showed clot burden in lungs.
Frequency: 1 affected / 4 at risk

Adverse event: left groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: discomfort in groin that feels like a twisting and jolt
Frequency: 1 affected / 4 at risk

Adverse event: Palpitations
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk