TABLE 3

Summary of severe, serious and hepatic treatment-emergent adverse events (TEAEs) (safety population#)

Patients with at least one TEAEPatients with at least one TEAE related to pirfenidone only+Patients with at least one TEAE related to nintedanib only+Patients with at least one TEAE related to both pirfenidone and nintedanib+
Severe TEAEs§
 ≥1 TEAE18 (20)
 ≥1 treatment-related TEAE6 (7)05 (6)1 (1)
  Diarrhoea2 (2)01 (1)1 (1)
  Nausea2 (2)02 (2)0
  Fatigue1 (1)01 (1)0
  Muscle spasms1 (1)01 (1)0
  Weight decreased1 (1)01 (1)0
  Deep vein thrombosis1 (1)01 (1)0
Serious TEAEsƒ
 ≥1 TEAE16 (18)
 ≥1 treatment-related TEAE2 (2)02 (2)0
  Transient ischaemic attack1 (1)01 (1)0
  Deep vein thrombosis1 (1)01 (1)0
Hepatic TEAEs
 ≥1 TEAE7 (8)
 ≥1 treatment-related TEAE6 (7)05 (6)1 (1)
  GGT increased2 (2)02 (2)0
  ALT increased2 (2)02 (2)0
  AST increased1 (1)01 (1)0
  Aminotransferase increased1 (1)01 (1)0
  Blood ALP increased1 (1)01 (1)0
  Hepatic function abnormal1 (1)01 (1)0
  Elevated liver function test1 (1)01 (1)0
  Elevated liver enzymes1 (1)001 (1)

Data are presented as n (%). GGT: γ-glutamyltransferase; ALT: alanine aminotransferase; AST: aspartate aminotransferase; ALP: alkaline phosphatase. #: n=89; : each of the patients could have experienced one or more treatment-related TEAE, with the potential for different events to be related to different treatments; +: assessed by investigators for each therapy using their previous experience with pirfenidone and/or nintedanib, knowledge of the patient, the circumstances surrounding the event, and an evaluation of any potential alternative causes; §: grade ≥3 using the AE severity grading scale for the Common Terminology Criteria for Adverse Events (version 4.03) [23]; ƒ: meet any of the following criteria: are fatal or life-threatening, require or prolong inpatient hospitalisation, result in persistent or significant disability or incapacity, are congenital anomalies or birth defects in a neonate or infant born to a mother exposed to study drug, or are significant medical events in the investigator's judgement.