Study: NCT01753830

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Not related to study product or injection procedure; Resulted in death
Frequency: 1 affected / 37 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Not related to study product or injection procedure
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to study product or injection procedure
Frequency: 1 affected / 37 at risk

Adverse event: Injection site joint pain
Serious: no
Organ System: General disorders
Notes: Definitely, probably, or possibly related to the study product and/or injection procedure
Frequency: 2 affected / 37 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Definitely, probably, or possibly related to the study product and/or injection procedure
Frequency: 3 affected / 37 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study product or injection procedure
Frequency: 2 affected / 37 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One event in Durolane group assessed as definitely, probably, or possibly related to the study product and/or injection procedure. The other events not related to study product or injection procedure.
Frequency: 2 affected / 37 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Both events in Durolane group and 1 event in PBS group definitely, probably, or possibly related to the study product and/or injection procedure. 1 event in PBS group not related to study product or injection procedure.
Frequency: 2 affected / 37 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 6 events in Durolane group and 1 event in PBS group assessed as definitely, probably, or possibly related to the study product and/or injection procedure. The rest of the events not related to study product or injection procedure.
Frequency: 7 affected / 37 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study product or injection procedure
Frequency: 1 affected / 37 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related to study product or injection procedure
Frequency: 1 affected / 38 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Not related to study product or injection procedure; Pre-treatment
Frequency: 1 affected / 38 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Definitely, probably, or possibly related to the study product and/or injection procedure
Frequency: 2 affected / 38 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Definitely, probably, or possibly related to the study product and/or injection procedure
Frequency: 2 affected / 38 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not related to study product or injection procedure
Frequency: 2 affected / 38 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study product or injection procedure
Frequency: 3 affected / 38 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One event in Durolane group assessed as definitely, probably, or possibly related to the study product and/or injection procedure. The other events not related to study product or injection procedure.
Frequency: 3 affected / 38 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Both events in Durolane group and 1 event in PBS group definitely, probably, or possibly related to the study product and/or injection procedure. 1 event in PBS group not related to study product or injection procedure.
Frequency: 3 affected / 38 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 6 events in Durolane group and 1 event in PBS group assessed as definitely, probably, or possibly related to the study product and/or injection procedure. The rest of the events not related to study product or injection procedure.
Frequency: 3 affected / 38 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study product or injection procedure
Frequency: 2 affected / 38 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 event in PBS group assessed as definitely, probably, or possibly related to the study product and/or injection procedure. The rest of the events not related to study product or injection procedure.
Frequency: 3 affected / 38 at risk