Adverse event specific tables

Linda Sharples; Matthew Glover; Abigail Clutterbuck-James; Maxine Bennett; Jake Jordan; Rebecca Chadwick; Marcus Pittman; Clare East; Malcolm Cameron; Mike Davies; Nick Oscroft; Ian Smith; Mary Morrell; Julia Fox-Rushby; Timothy Quinnell

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Sharples L, Glover M, Clutterbuck-James A, et al. Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure. Southampton (UK): NIHR Journals Library; 2014 Oct. (Health Technology Assessment, No. 18.67.)

Cover of Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure

Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure.

Show details

Contents

< Prev Next >

Appendix 9Adverse event specific tables

Serious adverse events

AE	Dates	Treatment receiving at the time	Classification
Sick sinus syndrome and atrial flutter	25 September 2011–28 September 2011	No treatment	Possibly related to OSA
Hypoglycaemia	13 October 2011–13 October 2011	No treatment	Possibly related to OSA
Complete heart block	3 November 2011–4 November 2011	bMAD	Possibly related to OSA or MAD
Non-specific chest pain	11 February 2012–17 February 2012	bMAD	Possibly related to OSA or MAD

Specific minor adverse events in each category

Adverse event	Adverse events category	Number of events
Achy legs	(1) General adverse events	4
Acid reflux	(1) General adverse events	2
Angina	(1) General adverse events	2
Asthma	(1) General adverse events	2
Asthma episode	(1) General adverse events	1
Bronchitis	(1) General adverse events	2
Cellulitis	(1) General adverse events	1
Chest (6) infection	(1) General adverse events	8
Chest (6) infection/pleuracy	(1) General adverse events	2
Concussion	(1) General adverse events	1
Cramp	(1) General adverse events	3
Cramp (legs)	(1) General adverse events	3
DVT	(1) General adverse events	3
Depression (re-occurring)	(1) General adverse events	1
Diarrhoea	(1) General adverse events	2
Diarrhoea and vomiting	(1) General adverse events	3
Dislocated shoulder	(1) General adverse events	1
Extreme tiredness [viral (6) infection?]	(1) General adverse events	1
Fluid on lungs	(1) General adverse events	1
Fractured wrist	(1) General adverse events	1
Gout	(1) General adverse events	1
Hay fever	(1) General adverse events	2
Hay fever symptoms	(1) General adverse events	1
Head trauma	(1) General adverse events	1
Headache	(1) General adverse events	27
Headache (migraine?)	(1) General adverse events	1
Headaches	(1) General adverse events	4
Hernia operation	(1) General adverse events	1
Hysterectomy	(1) General adverse events	1
Indigestion	(1) General adverse events	3
Infected finger	(1) General adverse events	4
Knee (6) infection	(1) General adverse events	2
Leg pain	(1) General adverse events	5
Nasal polyps	(1) General adverse events	3
Nasal congestion due to polyps	(1) General adverse events	1
Nasal (6) Infection	(1) General adverse events	1
Nausea	(1) General adverse events	2
Neck pain	(1) General adverse events	2
Operation – adenoma (parathyroid)	(1) General adverse events	1
Oral thrush	(1) General adverse events	1
Pacemaker fitted	(1) General adverse events	1
Panic attacks	(1) General adverse events	1
Period pain	(1) General adverse events	1
Shoulder pain	(1) General adverse events	5
Shoulder pain (frozen shoulder)	(1) General adverse events	1
Sore ribs	(1) General adverse events	3
Sore wrist/hand	(1) General adverse events	1
Stomach eramps	(1) General adverse events	1
Stomach ache	(1) General adverse events	1
Stomach ache/nausea	(1) General adverse events	1
Stomach bug	(1) General adverse events	5
Surgery to remove nasal polyps	(1) General adverse events	1
Torn ligaments (in knee)	(1) General adverse events	2
Unwell (exhaustion)	(1) General adverse events	1
Upset stomach	(1) General adverse events	1
Vomiting	(1) General adverse events	1
Wheezing	(1) General adverse events	1
Whiplash	(1) General adverse events	1
Worsening tinnitus	(1) General adverse events	1
Bad taste in mouth	(2) Dryness/Bad taste/Numbness	3
Dry lips	(2) Dryness/Bad taste/Numbness	14
Dry mouth	(2) Dryness/Bad taste/Numbness	65
Dry throat	(2) Dryness/Bad taste/Numbness	3
Dry mouth/throat	(2) Dryness/Bad taste/Numbness	1
Numb lips	(2) Dryness/Bad taste/Numbness	3
Bit lip	(3) Discomfort/Mouth problems	1
Blisters on lip	(3) Discomfort/Mouth problems	1
Blood on device	(3) Discomfort/Mouth problems	1
Broken tooth	(3) Discomfort/Mouth problems	3
Broken tooth crown	(3) Discomfort/Mouth problems	2
Burnt mouth	(3) Discomfort/Mouth problems	2
Change in bite	(3) Discomfort/Mouth problems	10
Change in bite/malocclusion	(3) Discomfort/Mouth problems	1
Clicky jaw	(3) Discomfort/Mouth problems	2
Cold sores	(3) Discomfort/Mouth problems	1
Dental bridge problems	(3) Discomfort/Mouth problems	1
Face/jaw ache	(3) Discomfort/Mouth problems	1
Gum discomfort	(3) Discomfort/Mouth problems	75
Gum sores	(3) Discomfort/Mouth problems	1
Infected milk tooth extraction	(3) Discomfort/Mouth problems	1
Jaw discomfort	(3) Discomfort/Mouth problems	78
Jaw stiffness	(3) Discomfort/Mouth problems	19
Jaw discomfort – left	(3) Discomfort/Mouth problems	1
Jaw discomfort – right	(3) Discomfort/Mouth problems	1
Jaw stiffness (change in bite)	(3) Discomfort/Mouth problems	1
Lip discomfort	(3) Discomfort/Mouth problems	3
Loose tooth	(3) Discomfort/Mouth problems	2
Loose crowns and bridges	(3) Discomfort/Mouth problems	1
Loose teeth	(3) Discomfort/Mouth problems	2
Loose tooth	(3) Discomfort/Mouth problems	2
Malocclusion (tooth moving forward)	(3) Discomfort/Mouth problems	1
Mouth discomfort	(3) Discomfort/Mouth problems	19
Mouth ulcer	(3) Discomfort/Mouth problems	16
Receding gums	(3) Discomfort/Mouth problems	3
Sensitive teeth	(3) Discomfort/Mouth problems	1
Sore throat (due to not wearing device)	(3) Discomfort/Mouth problems	1
Sore upper left palate.	(3) Discomfort/Mouth problems	1
Sore upper right palate.	(3) Discomfort/Mouth problems	1
Teeth moved forward (front top 2)	(3) Discomfort/Mouth problems	1
Tongue discomfort	(3) Discomfort/Mouth problems	8
Tongue ulcer	(3) Discomfort/Mouth problems	1
Tooth discomfort	(3) Discomfort/Mouth problems	128
Tooth discomfort (from clenching teeth)	(3) Discomfort/Mouth problems	4
Tooth discomfort (front crown only)	(3) Discomfort/Mouth problems	1
Tooth discomfort (next to abscessed tooth)	(3) Discomfort/Mouth problems	2
Tooth crown – permanent	(3) Discomfort/Mouth problems	1
Tooth crown – temporary	(3) Discomfort/Mouth problems	1
Tooth crown replacement	(3) Discomfort/Mouth problems	1
Tooth removal	(3) Discomfort/Mouth problems	1
Veneer detachment	(3) Discomfort/Mouth problems	1
Wound healing post wisdom tooth removal	(3) Discomfort/Mouth problems	1
Bleeding gums	(3) Discomfort/Mouth problems	18
Choking	(4) Excessive salivation and choking	2
Choking (due to excessive salivation)	(4) Excessive salivation and choking	1
Excessive Salivation	(4) Excessive salivation and choking	83
Gagging	(4) Excessive salivation and choking	5
Blocked nose	(5) Cold related	14
Cold/sore throat	(5) Cold related	1
Chest and sinus (6) infection	(5) Cold related	1
Common cold	(5) Cold related	39
Cough	(5) Cold related	13
Cough and congestion	(5) Cold related	2
Flu	(5) Cold related	3
Head cold	(5) Cold related	1
Nasal congestion	(5) Cold related	4
Sinus (6) infection	(5) Cold related	1
Sore throat	(5) Cold related	8
Sore throat (and cough)	(5) Cold related	2
Sore nostrils	(5) Cold related	1
Sore throat and ears	(5) Cold related	1
Sore throat and nose	(5) Cold related	1
Throat and upper and lower chest (6) Infection	(5) Cold related	1
Tonsillitis	(5) Cold related	1
Viral (6) infection	(5) Cold related	2
Viral nasal (6) infection	(5) Cold related	1
Infected wisdom tooth	(6) Infection	3
Infected milk tooth	(6) Infection	1
Tooth abscess	(6) Infection	2
Tooth (6) infection	(6) Infection	2

Minor adverse events (classified by an independent sleep physician)

Type of AE	No treatment (n = 78)	SP1 (n = 81)	SP2 (n = 78)	bMAD (n = 77)	Total
Possibly related to OSA	3 (3)	1 (1)	3 (3)	1 (1)	8 (5)
Probably related to MAD	22 (16)	179 (66)	143 (59)	184 (75)	528 (85)
Possibly related to OSA or MAD	29 (18)	50 (34)	55 (35)	40 (27)	174 (54)
Probably unrelated	26 (21)	37 (24)	41 (30)	37 (27)	141 (59)
Total	80 (45)	267 (73)	242 (68)	262 (76)	851 (86)

Copyright © Queen’s Printer and Controller of HMSO 2014. This work was produced by Sharples et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK262684

Contents

< Prev Next >

PubReader
Print View
Cite this Page
Sharples L, Glover M, Clutterbuck-James A, et al. Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure. Southampton (UK): NIHR Journals Library; 2014 Oct. (Health Technology Assessment, No. 18.67.) Appendix 9, Adverse event specific tables.
PDF version of this title (3.8M)

Adverse event specific tables - Clinical effectiveness and cost-effectiveness re...
Adverse event specific tables - Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure
Questions to CLINICAL specialist committee members and responses received - A cl...
Questions to CLINICAL specialist committee members and responses received - A cloud-based medical device for predicting cardiac risk in suspected coronary artery disease: a rapid review and conceptual economic model
Search strategies for electronic databases - An Evidence Synthesis of Qualitativ...
Search strategies for electronic databases - An Evidence Synthesis of Qualitative and Quantitative Research on Component Intervention Techniques, Effectiveness, Cost-Effectiveness, Equity and Acceptability of Different Versions of Health-Related Lifestyle Advisor Role in Improving Health
Literature search strategies - A cloud-based medical device for predicting cardi...
Literature search strategies - A cloud-based medical device for predicting cardiac risk in suspected coronary artery disease: a rapid review and conceptual economic model
Acknowledgements - Echocardiography in newly diagnosed atrial fibrillation patie...
Acknowledgements - Echocardiography in newly diagnosed atrial fibrillation patients: a systematic review and economic evaluation

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

Bookshelf

Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure.

Appendix 9Adverse event specific tables

Serious adverse events

Specific minor adverse events in each category

Minor adverse events (classified by an independent sleep physician)

Views

In this Page

Other titles in this collection

Recent Activity