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Table 2 Study 2 (MAD) TEAEs. All causalities (treatment-related)

From: Safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06650833, a selective interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor, in single and multiple ascending dose randomized phase 1 studies in healthy subjects

 PlaceboaPF-06650833 dose group
IR 25 mg BIDIR 100 mg BIDIR 250 mg BIDIR 750 mg BIDIR 1000 mg QIDIR 330 mg TIDMR 300 mg QD
Subjects evaluable for AEs158888888
Subjects with AEs6 (2)3 (1)4 (2)3 (2)5 (5)7 (4)3 (2)4 (2)
Number of AEs9 (3)3 (1)5 (2)9 (7)17 (13)11 (6)4 (2)4 (2)
Number of subjects with AEs by system organ class and preferred term
 Blood and lymphatic system disorders000001 (1)00
  Neutropenia000001 (1)00
 Ear and labyrinth disorders000001 (0)00
  Hypoacusis000001 (0)00
 Eye disorders1 (0)00001 (0)00
  Conjunctival hyperemia1 (0)0000000
  Conjunctival irritation000001 (0)00
 Gastrointestinal disorders1 (0)1 (0)2 (2)2 (2)1 (1)2 (2)00
  Abdominal discomfort1 (0)0000000
  Abdominal pain upper002 (2)01 (1)000
  Diarrhea000001 (1)00
  Feces hard01 (0)000000
  Feces soft00001 (0)000
  Flatulence000001 (1)00
  Gastroesophageal reflux disease00001 (1)000
  Nausea0002 (2)1 (1)000
  Vomiting00001 (1)000
 General disorders and administration site conditions0001 (1)1 (1)1 (1)1 (1)0
  Asthenia0001 (1)0000
  Fatigue00001 (1)000
  Feeling abnormal0000001 (1)0
  Feeling hot000001 (1)00
 Infections and infestations1 (1)01 (0)01 (1)001 (0)
  Folliculitis00001 (1)000
  Hordeolum00000001 (0)
  Upper respiratory tract infection1 (1)01 (0)00000
 Injury, poisoning, and procedural complications1 (0)001 (0)0000
  Arthropod bite1 (0)001 (0)0000
 Metabolism and nutrition disorders00001 (1)000
  Decreased appetite00001 (1)000
 Musculoskeletal and connective tissue disorders01 (0)1 (0)01 (0)1 (0)00
  Back pain01 (0)000000
  Muscle spasms00001 (0)1 (0)00
  Neck pain001 (0)00000
 Nervous system disorders1 (0)1 (1)02 (2)4 (4)3 (2)00
  Dizziness0001 (1)0000
  Headache1 (0)1 (1)01 (1)4 (4)2 (2)00
  Presyncope000001 (0)00
  Somnolence0001 (1)0000
 Psychiatric disorders001 (0)01 (1)000
  Anxiety00001 (1)000
  Insomnia001 (0)00000
 Renal and urinary disorders00001 (0)01 (0)1 (1)
  Nocturia00001 (0)000
  Polyuria0000001 (0)1 (1)
 Respiratory, thoracic, and mediastinal disorders1 (1)0002 (1)01 (1)0
  Epistaxis00001 (0)000
  Nasal congestion1 (1)000001 (1)0
  Oropharyngeal pain00001 (1)000
 Skin and subcutaneous tissue disorders3 (1)002 (1)01 (0)1 (0)2 (1)
  Acne1 (1)001 (1)0001 (1)
  Aquagenic pruritus000001 (0)00
  Dermatitis contact0000001 (0)0
  Dry skin1 (0)0000000
  Ecchymosis1 (0)001 (0)0000
  Skin irritation00000001 (0)
  1. Subjects were counted only once per treatment in each row. The table includes all data collected since the first dose of study drug
  2. AE adverse event, BID twice daily, IR immediate-release, MAD multiple ascending doses, MR modified-release, QD once daily, QID four times per day, TEAE treatment-emergent AE, TID three times per day
  3. aRepresents placebo groups (IR placebo and MR placebo) in all cohorts