Study: NCT01906372

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject hospitalized for a total left hip arthroplasty which confirmed diagnosis of avascular necrosis. Site investigator reported this event as probably related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Local infection with moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, a
Serious: yes
Organ System: Infections and infestations
Notes: One subject with diagnosis of disseminating herpes zoster and one subject with herpes zoster infection. Both subjects received IV antivirals.
Frequency: 2 affected / 10 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Notes: Subject was hospitalized for a third degree AV heart block with subsequent transvenous pacemaker placed. The site investigator reported this event as not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: Subsequent testing ruled out cardiac event. Discharge diagnosis of chest pain most likely musculoskeletal. Site investigator reported this event as unlikely related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Sinus tachycardia confirmed by electrocardigram. PI feels that this is likely related to the SAE of dissemenated herpes zoster infection which was deemed possibly related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Bruising at injection site.
Frequency: 4 affected / 10 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Upper Respiratory Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 10 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Subject reported worsening of anxiety symptoms.
Frequency: 1 affected / 10 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lung nodules
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Chest x-ray and computerized tomography scan revealed nodules in both lungs. Chest x-ray from 5 days earlier was unremarkable. Lung biopsy was done and tests confirmed the pulmonary nodules were most likely caused by the herpes zoster virus.
Frequency: 1 affected / 10 at risk

Adverse event: Calcinosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One subject with subtle worsening of the subcutaneous calcinosis confirmed on imaging studies. One subject with significant new calcification in left breast which were not present prior to Acthar administration.
Frequency: 2 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 10 at risk