Work package 3.3: adverse events

Martin J Wildman; Alicia O’Cathain; Daniel Hind; Chin Maguire; Madelynne A Arden; Marlene Hutchings; Judy Bradley; Stephen J Walters; Pauline Whelan; John Ainsworth; Paul Tappenden; Iain Buchan; Rachel Elliott; Jon Nicholl; Stuart Elborn; Susan Michie; Laura Mandefield; Laura Sutton; Zhe Hui Hoo; Sarah J Drabble; Elizabeth Lumley; Daniel Beever; Aline Navega Biz; Anne Scott; Simon Waterhouse; Louisa Robinson; Mónica Hernández Alava; Alessandro Sasso

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Wildman MJ, O’Cathain A, Hind D, et al. An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT. Southampton (UK): NIHR Journals Library; 2021 Oct. (Programme Grants for Applied Research, No. 9.11.)

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An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT.

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Appendix 6Work package 3.3: adverse events

TABLE 17

Detailed list of adverse events in RCT

Adverse event	Usual care (n = 303), n (%)	Intervention (n = 305), n (%)	Overall (n = 608), n (%)
Non-serious adverse events
All AEs	301 (46.9)	341 (53.1)	642 (100.0)
Participants experiencing at least one AE	125 (41.3)	139 (45.6)	264 (43.4)
AEs by category
Expected or common event^a	242 (80.4)	263 (77.1)	505 (78.7)
01 Acute FEV₁ drop > 15% after first dose of medication	1 (0.4)	2 (0.8)	3 (0.6)
02 Increased productive cough	62 (25.6)	73 (27.8)	135 (26.7)
03 Nasal congestion or stuffy nose	12 (5.0)	10 (3.8)	22 (4.4)
04 Chest congestion	8 (3.3)	15 (5.7)	23 (4.6)
05 Wheezing	8 (3.3)	10 (3.8)	18 (3.6)
06 Chest pain or chest discomfort	18 (7.4)	11 (4.2)	29 (5.7)
07 Voice alteration/change	4 (1.7)	2 (0.8)	6 (1.2)
08 Dyspnoea (breathlessness)	17 (7)	14 (5.3)	31 (6.1)
09 Haemoptysis (coughing blood)	26 (10.7)	40 (15.2)	66 (13.1)
10 Rhinitis	1 (0.4)	2 (0.8)	3 (0.6)
11 Headache	3 (1.2)	4 (1.5)	7 (1.4)
12 Crackles in lung	9 (3.7)	6 (2.3)	15 (3.0)
13 Throat irritation/sore throat	15 (6.2)	12 (4.6)	27 (5.3)
14 Upper respiratory tract infection	6 (2.5)	8 (3.0)	14 (2.8)
15 Sinusitis	3 (1.2)	3 (1.1)	6 (1.2)
16 Deafness	0 (0.0)	1 (0.4)	1 (0.2)
17 Indigestion/reflux	2 (0.8)	0 (0.0)	2 (0.4)
18 Tonsillitis	0 (0.0)	1 (0.4)	1 (0.2)
19 Joint pain	2 (0.8)	5 (1.9)	7 (1.4)
20 Decreased appetite	5 (2.1)	1 (0.4)	6 (1.2)
21 Fatigue	12 (5.0)	6 (2.3)	18 (3.6)
22 Headache	0 (0.0)	3 (1.1)	3 (0.6)
23 Distal intestinal obstructive syndrome	0 (0.0)	1 (0.4)	1 (0.2)
24 Fever	2 (0.8)	3 (1.1)	5 (1.0)
25 Otitis media or ear infection	1 (0.4)	2 (0.8)	3 (0.6)
26 Conjunctivitis	0 (0.0)	0 (0.0)	0 (0.0)
27 Pneumothorax	2 (0.8)	2 (0.8)	4 (0.8)
28 Decreased exercise tolerance	1 (0.4)	1 (0.4)	2 (0.4)
29 Pyrexia	1 (0.4)	0 (0.0)	1 (0.2)
30 Abdominal pain	4 (1.7)	14 (5.3)	18 (3.6)
31 Influenza	3 (1.2)	4 (1.5)	7 (1.4)
32 New Pseudomonas infection since recruitment in patient who was previously Pseudomonas free	6 (2.5)	2 (0.8)	8 (1.6)
33 Vomiting	4 (1.7)	4 (1.5)	8 (1.6)
34 New diagnosis of diabetes	4 (1.7)	1 (0.4)	5 (1.0)
35 Pneumonia	0 (0.0)	0 (0.0)	0 (0.0)
New depression requiring treatment	1 (0.3)	5 (1.5)	6 (0.9)
Other	58 (19.3)	73 (21.4)	131 (20.4)
Serious adverse events
All SAEs	64 (47.4)	71 (52.6)	135 (100.0)
Participants experiencing at least one SAE	43 (14.2)	56 (18.4)	99 (16.3)
SAEs by category
Expected or common event^a	21 (32.8)	28 (39.4)	49 (36.3)
01 Acute FEV₁ drop > 15% after first dose of medication	0 (0.0)	0 (0.0)	0 (0.0)
02 Increased productive cough	2 (9.5)	2 (7.1)	4 (8.2)
03 Nasal congestion or stuffy nose	0 (0.0)	0 (0.0)	0 (0.0)
04 Chest congestion	0 (0.0)	0 (0.0)	0 (0.0)
05 Wheezing	0 (0.0)	1 (3.6)	1 (2.0)
06 Chest pain or chest discomfort	1 (4.8)	1 (3.6)	2 (4.1)
07 Voice alteration/change	0 (0.0)	0 (0.0)	0 (0.0)
08 Dyspnoea (breathlessness)	0 (0.0)	3 (10.7)	3 (6.1)
09 Haemoptysis (coughing blood)	1 (4.8)	5 (17.9)	6 (12.2)
10 Rhinitis	0 (0.0)	0 (0.0)	0 (0.0)
11 Headache	0 (0.0)	0 (0.0)	0 (0.0)
12 Crackles in lung	0 (0.0)	0 (0.0)	0 (0.0)
13 Throat irritation/sore throat	0 (0.0)	1 (3.6)	1 (2.0)
14 Upper respiratory tract infection	0 (0.0)	0 (0.0)	0 (0.0)
15 Sinusitis	0 (0.0)	0 (0.0)	0 (0.0)
16 Deafness	0 (0.0)	0 (0.0)	0 (0.0)
17 Indigestion/reflux	0 (0.0)	0 (0.0)	0 (0.0)
18 Tonsillitis	0 (0.0)	0 (0.0)	0 (0.0)
19 Joint pain	0 (0.0)	0 (0.0)	0 (0.0)
20 Decreased appetite	0 (0.0)	0 (0.0)	0 (0.0)
21 Fatigue	0 (0.0)	0 (0.0)	0 (0.0)
22 Headache	0 (0.0)	0 (0.0)	0 (0.0)
23 Distal intestinal obstructive syndrome	3 (14.3)	5 (17.9)	8 (16.3)
24 Fever	0 (0.0)	0 (0.0)	0 (0.0)
25 Otitis media or ear infection	0 (0.0)	0 (0.0)	0 (0.0)
26 Conjunctivitis	0 (0.0)	0 (0.0)	0 (0.0)
27 Pneumothorax	2 (9.5)	0 (0.0)	2 (4.1)
28 Decreased exercise tolerance	0 (0.0)	0 (0.0)	0 (0.0)
29 Pyrexia	0 (0.0)	0 (0.0)	0 (0.0)
30 Abdominal pain	9 (42.9)	2 (7.1)	11 (22.4)
31 Influenza	1 (4.8)	1 (3.6)	2 (4.1)
32 New Pseudomonas infection since recruitment in patient who was previously Pseudomonas free	0 (0.0)	1 (3.6)	1 (2.0)
33 Vomiting	2 (9.5)	5 (17.9)	7 (14.3)
34 New diagnosis of diabetes	0 (0.0)	1 (3.6)	1 (2.0)
35 Pneumonia	0 (0.0)	0 (0.0)	0 (0.0)
New depression requiring treatment	0 (0.0)	0 (0.0)	0 (0.0)
Other	41 (64.1)	42 (59.2)	83 (61.5)
Unknown	2 (3.1)	1 (1.4)	3 (2.2)

a: Expected events by type are presented as percentage of total expected events.

Copyright © 2021 Wildman et al. This work was produced by Wildman et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

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Wildman MJ, O’Cathain A, Hind D, et al. An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT. Southampton (UK): NIHR Journals Library; 2021 Oct. (Programme Grants for Applied Research, No. 9.11.) Appendix 6, Work package 3.3: adverse events.
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Appendix 6Work package 3.3: adverse events

TABLE 17

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