Study: NCT02436876

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: This patient had significant underlying co-morbidities. A total of 10 non-drug-related SAEs were recorded. Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Device failure
Serious: yes
Organ System: Product Issues
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 2 affected / 6 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Product Issues
Notes: This was a drug hypersensitivity to a concommitant medication (Bactrim). Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Serious injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Road traffic accident causing multiple injuries. Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Linear Immunoglobulin A disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 2 affected / 6 at risk

Adverse event: Increased measurement of systemic C-reactive protein
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 2 affected / 6 at risk

Adverse event: Increased measurement of systemic red blood cell sedimentation rate
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 2 affected / 6 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo) for one subject in the 0.5 µg/cm2 cohort, but possibly related to one subject in each of the 0.5 µg/cm2, 1.5 µg/cm2, 5.0 µg/cm2, and placebo cohorts.
Frequency: 2 affected / 6 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 6 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo) for one subject in the 0.5 µg/cm2 cohort, but possibly related to one subject in each of the 0.5 µg/cm2, 1.5 µg/cm2, 5.0 µg/cm2, and placebo cohorts.
Frequency: 1 affected / 6 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo) for one subject in the 0.5 µg/cm2 cohort, but possibly related to one subject in each of the 0.5 µg/cm2, 1.5 µg/cm2, 5.0 µg/cm2, and placebo cohorts.
Frequency: 1 affected / 6 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 7 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 7 at risk

Adverse event: C. difficile infection
Serious: yes
Organ System: Infections and infestations
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 7 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 2 affected / 7 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 1 affected / 7 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo).
Frequency: 3 affected / 7 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not considered possibly or probably related to study drug (MBN-101 or placebo) for one subject in the 0.5 µg/cm2 cohort, but possibly related to one subject in each of the 0.5 µg/cm2, 1.5 µg/cm2, 5.0 µg/cm2, and placebo cohorts.
Frequency: 1 affected / 7 at risk