Study: NCT02933489

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death not otherwise specified \[NOS\] occurring more than 461 days after the year 0 screening intervention.
Frequency: 3 affected / 1444 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Notes: Disease progression \[Death\] This death occurred 395 days after the year 0 screening intervention and after hospital admission for neurosurgery for metastatic disease to the brain.
Frequency: 1 affected / 1444 at risk

Adverse event: Malignant neoplasm of the right lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Malignant neoplasm of the right lung \[Death\] occurring 136 days after the year 0 screening intervention.
Frequency: 1 affected / 1444 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: Intracranial hemorrhage \[Death\] occurring 106 days after the year 0 screening intervention.
Frequency: 1 affected / 1444 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory failure \[Death\] This death occurred 395 days after the year 0 screening intervention and after hospital admission for neurosurgery for metastatic disease to the brain.
Frequency: 1 affected / 1444 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Vertigo \[Mild symptoms\]
Frequency: 1 affected / 1444 at risk

Adverse event: Bilateral Eye swelling
Serious: no
Organ System: Eye disorders
Notes: Bilateral Eye swelling \[Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; no change in vision\]
Frequency: 1 affected / 1444 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea \[Loss of appetite without alteration in eating habits\]
Frequency: 2 affected / 1444 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting \[3 - 5 episodes (separated by 5 minutes) in 24 hrs\]
Frequency: 1 affected / 1444 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: Facial rash \[Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated\]
Frequency: 1 affected / 1444 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Notes: Infusion site extravasation \[Painless edema\]
Frequency: 1 affected / 1444 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Notes: Localized edema \[Moderate localized edema and intervention indicated; limiting instrumental ADL\]
Frequency: 1 affected / 1444 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain \[Mild pain\]
Frequency: 1 affected / 1444 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergic reaction \[Intervention or infusion interruption indicated; responds promptly to symptomatic treatment (e.g., antihistamines, NSAIDS, narcotics); prophylactic medications indicated for \<=24 hrs\]
Frequency: 2 affected / 1444 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergic reaction \[Transient flushing or rash, drug fever \<38 degrees C (\<100.4 degrees F); intervention not indicated\]
Frequency: 1 affected / 1444 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Bruising \[Localized or in a dependent area\]
Frequency: 1 affected / 1444 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Vascular access complication \[Device dislodgement, blockage, leak, or malposition; device replacement indicated\]
Frequency: 2 affected / 1444 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain \[Mild pain\]
Frequency: 1 affected / 1444 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Vasovagal reaction \[Present\]
Frequency: 2 affected / 1444 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety \[Mild symptoms; intervention not indicated\]
Frequency: 2 affected / 1444 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Breast pain \[Moderate pain; limiting Instrumental activities of daily living (IADL)
Frequency: 1 affected / 1444 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough \[Mild symptoms; nonprescription intervention indicated\]
Frequency: 1 affected / 1444 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Flushing \[Asymptomatic; clinical or diagnostic observations only; intervention not indicated\]
Frequency: 1 affected / 1444 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Hematoma \[Mild symptoms; intervention not indicated\]
Frequency: 1 affected / 1444 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Hematoma \[Minimally invasive evacuation or aspiration indicated\]
Frequency: 1 affected / 1444 at risk