Patients with at least one TEAE¶ | Patients 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 TEAE | 18 (20) | |||
≥1 treatment-related TEAE | 6 (7) | 0 | 5 (6) | 1 (1) |
Diarrhoea | 2 (2) | 0 | 1 (1) | 1 (1) |
Nausea | 2 (2) | 0 | 2 (2) | 0 |
Fatigue | 1 (1) | 0 | 1 (1) | 0 |
Muscle spasms | 1 (1) | 0 | 1 (1) | 0 |
Weight decreased | 1 (1) | 0 | 1 (1) | 0 |
Deep vein thrombosis | 1 (1) | 0 | 1 (1) | 0 |
Serious TEAEsƒ | ||||
≥1 TEAE | 16 (18) | |||
≥1 treatment-related TEAE | 2 (2) | 0 | 2 (2) | 0 |
Transient ischaemic attack | 1 (1) | 0 | 1 (1) | 0 |
Deep vein thrombosis | 1 (1) | 0 | 1 (1) | 0 |
Hepatic TEAEs | ||||
≥1 TEAE | 7 (8) | |||
≥1 treatment-related TEAE | 6 (7) | 0 | 5 (6) | 1 (1) |
GGT increased | 2 (2) | 0 | 2 (2) | 0 |
ALT increased | 2 (2) | 0 | 2 (2) | 0 |
AST increased | 1 (1) | 0 | 1 (1) | 0 |
Aminotransferase increased | 1 (1) | 0 | 1 (1) | 0 |
Blood ALP increased | 1 (1) | 0 | 1 (1) | 0 |
Hepatic function abnormal | 1 (1) | 0 | 1 (1) | 0 |
Elevated liver function test | 1 (1) | 0 | 1 (1) | 0 |
Elevated liver enzymes | 1 (1) | 0 | 0 | 1 (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.