Table 2A.

Summary of TEAE. Values are n (%).

TEAE*Pirfenidone, 2403 mg/day
2-week Titration Group, n = 324-week Titration Group, n = 31Total, n = 63
At least 1 TEAE31 (96.9)30 (96.8)61 (96.8)
Maximal intensity of TEAE**
  Mild***7 (21.9)12 (38.7)19 (30.2)
  Moderate15 (46.9)15 (48.4)30 (47.6)
  Severe***9 (28.1)3 (9.7)12 (19.0)
  Life-threatening000
Relationship of TEAE to study treatment
  Not related3 (9.4)2 (6.5)5 (7.9)
  Possibly related7 (21.9)6 (19.4)13 (20.6)
  Related21 (65.6)22 (71.0)43 (68.3)
At least 1 TE SAE3 (9.4)03 (4.8)
At least 1 treatment-related TE SAE††1 (3.1)01 (1.6)
Discontinuation of study treatment due to TEAE***5 (15.6)1 (3.2)6 (9.5)
Death as an outcome of a TEAE000
  • * AE were classified according to Medical Dictionary for Regulatory Activities, version 11.0, using preferred terms within each system organ class, and the severity of AE was recorded according to the Common Terminology Criteria for AE, version 4.028.

  • ** Each patient was counted only once as the maximal intensity of any event for that patient.

  • *** Events with treatment differences ≥ 10%; p values by the Fisher’s exact test all > 0.1.

  • Each patient was counted only once as the strongest relationship of any event for that patient.

  • As assigned by the investigator.

  • †† An AE was considered serious if it resulted in death, required hospitalization, resulted in persistent or significant disability, resulted in a congenital anomaly or birth defect, or was an important medical effect, defined as an event that may have jeopardized the patient and may have required intervention to prevent death, an immediate threat to life, or hospitalization. AE: adverse event; TEAE: treatment-emergent AE; TE SAE: treatment-emergent serious AE.