Table 3.

Safety results for 12-week treatment period

VariablePlacebo plus 60 mg Prednisone Control (n=23)Avacopan plus 20 mg Prednisone (n=22)Avacopan without Prednisone (n=22)
Patients with any adverse event, no. (%)21 (91)19 (86)21 (96)
Patients with any grade 3 or greater adverse event, no. (%)2 (9)2 (9)2 (9)
 Deep vein thrombosis01 (5)0
 Febrile infection01 (5)0
 Hepatic and pancreatic enzymes increased001 (5)
 Pneumonia1 (4)00
 Renal vasculitis1 (4)00
 Renal impairment001 (5)
Patients with any serious adverse event,a no. (%)4 (17)3 (14)8 (36)
 Vasculitis1 (4)1 (5)3 (14)
 Infection1 (4)1 (5)1 (5)
 Back pain and vertebral fracture1 (4)00
 C-reactive protein increase001 (5)
 Dehydration1 (4)00
 Hematuria01 (5)0
 Hepatic and pancreatic enzymes increased001 (5)
 Musculoskeletal chest pain01 (5)0
 Rash001 (5)
 Renal impairment001 (5)
Patients with any adverse effect potentially related to glucocorticoids, no. (%)15 (65)4 (18)11 (50)
 Psychiatric disordersb6 (26)2 (9)1 (5)
 New-onset or worsening hypertensionc5 (26)2 (9)8 (36)
 New-onset or worsening diabetes mellitus/hyperglycemiad4 (17)01 (5)
 Weight gain >10 kg2 (9)1 (5)0
 Bone fractures1 (4)00
 Cataracts1 (4)00
 Serious infections1 (4)1 (5)1 (5)
Safety laboratory abnormalitiese
 Lymphopenia
  Grade 21 (4)1 (5)3 (14)
  Grade 301 (5)3 (14)
 ALT increase, grade 21 (4)1 (5)1 (5)
 Bilirubin increase, grade 3001 (5)
 Creatine phosphokinase increase, grade 301 (5)0
  • ALT, alanine aminotransferase.

  • a Serious adverse events were defined as any adverse event that resulted in death, was immediately life threatening, required or prolonged hospitalization, resulted in persistent or significant disability or incapacity, was a birth defect, or was an important event that might jeopardize the patient or might have required intervention to prevent any of the above.

  • b All adverse events of psychosis, anxiety, amnesia, convulsions, delirium, dementia, depression, mania, emotional instability, irritability, euphoria, hallucinations, impaired cognition, increased motor activity, insomnia, memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, restlessness, schizophrenia, vertigo, or withdrawal behavior.

  • c Defined as adverse events of hypertension, worsening hypertension, or high BP, plus all patients with a systolic BP increase of at least 20 mmHg, and >140 mmHg (systolic), or diastolic BP increase of at least 10 mmHg, and >90 mmHg (diastolic), on at least two consecutive study visits.

  • d All adverse events of hyperglycemia, diabetes mellitus, increased blood glucose, plus all patients with a fasting blood glucose postbaseline that was above the upper limit of normal on at least two consecutive study visits.

  • e Grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, published: May 28, 2009 (v4.03: June 14, 2010), US Department of Health and Human Services, National Institutes of Health, National Cancer Institute.