Table 2 Frequency of adverse events in comparison to the INPULSIS I and II clinical trials
From: Early clinical experiences with nintedanib in three UK tertiary interstitial lung disease centres
Adverse event (AE) | Reported events | Percentage of total events (n = 723), % | Percentage of patients experiencing AE (n = 187), % | Percentage of patients experiencing AE from INPULSIS-I, % [7] | Percentage of patients experiencing AE from INPULSIS-II, % [7] |
|---|---|---|---|---|---|
Diarrhoea | 185 | 26 | 49.7 | 61.5 | 63.2 |
Nausea | 102 | 14 | 36.4 | 22.7 | 26.1 |
Reduced appetite | 65 | 9 | 23.5 | 8.4 | 12.8 |
Tiredness | 60 | 8 | 20.3 | – | – |
GOR | 53 | 7 | 18.2 | – | – |
Abdominal pain, bloating and wind | 58 | 8 | 24.1 | – | – |
Weight loss | 29 | 4 | 14.4 | 8.1 | 11.2 |
Vomiting | 21 | 3 | 8.6 | 12.9 | 10.3 |
Abnormal elevated LFTs | 20 | 3 | 9.6 | 4.9 | 5.2 |
Death | 18 | 2 | 9.6 | – | – |
Constipation | 12 | 2 | 4.3 | – | – |
Nose bleeds, haematemesis, haemoptysis | 16 | 2 | 7 | – | – |
Cough | 10 | 1 | 2.7 | 15.2 | 11.6 |
Taste disturbance | 9 | 1 | 3.7 | – | – |
Headache | 7 | 1 | 3.2 | – | – |
Mood disturbance | 7 | 1 | 2.7 | – | – |
Aching joints | 5 | 1 | 2.1 | – | – |
Chest discomfort | 5 | 1 | 0.5 | – | – |
Bronchitis | 5 | < 1 | 2.7 | 11.7 | 9.4 |
AKI | 4 | 1 | 1.6 | – | – |
Abnormal blood count results | 3 | < 1 | 1.6 | – | – |
Rash | 3 | < 1 | 1.1 | – | – |
Increased dyspnoea | 3 | < 1 | 1.1 | 7.1 | 8.2 |
Sleep disturbance | 3 | < 1 | 1.1 | – | – |
Dizziness | 2 | < 1 | 1.1 | – | – |
Recurrent urinary tract infections (UTIs) | 2 | < 1 | 0.5 | – | – |
MI | 2 | < 1 | 0.5 | 1.6 | 1.5 |
Pruritis | 3 | < 1 | 1.6 | – | – |
Other viral/bacterial infection | 2 | < 1 | 1.1 | – | – |
Mouth pain/swelling | 2 | < 1 | 1.1 | – | – |
Unknown | 2 | < 1 | 1.6 | – | – |
PE | 1 | < 1 | 0.5 | – | – |
Hair loss | 1 | < 1 | 0.5 | – | – |
Anosmia | 1 | < 1 | 0.5 | – | – |
Thigh/calf ache | 1 | < 1 | 0.5 | – | – |
Hypersalivation | 1 | < 1 | 0.5 | – | – |