Reasons for exclusion of participants from outcome analyses

W Lenney; AJ McKay; C Tudur Smith; PR Williamson; M James; D Price; MASCOT Study Group

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Lenney W, McKay AJ, Tudur Smith C, et al.; MASCOT Study Group. Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety. Southampton (UK): NIHR Journals Library; 2013 Feb. (Health Technology Assessment, No. 17.4.)

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Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety.

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Appendix 6Reasons for exclusion of participants from outcome analyses

Primary outcome intention-to-treat analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	11	15	12	38
Excluded – patient has primary outcome data past T24 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	4	2	4	10
Excluded – patient has primary outcome data past T36 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	1	0	1	2
Excluded – patient has primary outcome data only up to T24 as withdrew before T36	2	0	1	3
Excluded – patient has primary outcome data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8 so has no primary outcome data	0	1	1	2
Excluded – patient withdrew from trial treatment before T8; had no T8 visit but agreed to have data collected at T24	0	0	1	1

Primary outcome intention-to-treat analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	18	17	19	54
Excluded – patient has primary outcome data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8 so has no primary outcome data	0	1	1	2

Primary outcome per-protocol analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	9	11	8	28
Excluded – patient has primary outcome data past T24 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	4	2	4	10
Excluded – patient has primary outcome data past T36 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	1	0	1	2
Excluded – patient has primary outcome data up to T48 but did not take > 70% of tablets	0	0	1	1
Excluded – patient has primary outcome data up to T48 but has missing number of missed doses data for at least one visit	2	4	3	9
Excluded – patient has primary outcome data only up to T24 as withdrew before T36	2	0	1	3
Excluded – patient has primary outcome data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24 and has missing number of missed doses data for the T24 visit	0	0	1	1
Excluded – patient withdrew before T8 so has no primary outcome data	0	1	1	2

Primary outcome per-protocol analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	15	13	16	44
Excluded – patient has primary outcome data up to T24 but did not take > 70% of inhalers	0	1	0	1
Excluded – patient has primary outcome data up to T24 but did not take > 70% of tablets	0	0	1	1
Excluded – patient has primary outcome data up to T24 but has missing number of missed doses data for at least one visit	3	3	1	7
Excluded – patient has primary outcome data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24 and has missing number of missed doses data for the T24 visit	0	0	1	1
Excluded – patient withdrew before T8 so has no primary outcome data	0	1	1	2

PAQLQ(S) activity limitations domain score analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	10	14	12	36
Excluded – patient completed up to T48 but has no PAQLQ(S) for T48	1	0	0	1
Excluded – patient has a final PAQLQ(S) but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	5	2	5	12
Excluded – patient has a T0 and T48 PAQLQ(S) but has a missing answer in the activity limitations domain at T0	0	1	0	1
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T36 and last PAQLQ(S) questionnaire does not reach the minimum of 43 weeks to be included in the T48 analysis	2	0	1	3
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. Only has a T0 PAQLQ(S)	0	0	1	1

PAQLQ(S) activity limitations domain score analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	17	15	17	49
Excluded – patient completed up to T24 but has no PAQLQ(S) for T24	1	1	1	3
Excluded – patient has a T0 and T24 PAQLQ(S) but has a missing answer in the activity limitations domain at T0	0	1	0	1
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. Only has a T0 PAQLQ(S)	0	0	1	1

PAQLQ(S) activity limitations domain score analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	17	15	17	49
Excluded – patient completed up to T24 but has no PAQLQ(S) for T24	1	1	1	3
Excluded – patient has a T0 and T24 PAQLQ(S) but has a missing answer in the activity limitations domain at T0	0	1	0	1
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. No PAQLQ(S) was filled in at T24	0	0	1	1

PAQLQ(S) symptoms domain score analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	10	15	12	37
Excluded – patient completed up to T48 but has no PAQLQ(S) for T48	1	0	0	1
Excluded – patient has a final PAQLQ(S) but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	5	2	5	12
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T36 and last PAQLQ(S) does not reach the minimum of 43 weeks to be included in the T48 analysis	2	0	1	3
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. Only has a T0 PAQLQ(S)	0	0	1	1

PAQLQ(S) symptoms domain score analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	17	16	17	50
Excluded – patient completed up to T24 but has no PAQLQ(S) for T24	1	1	1	3
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. No PAQLQ(S) was filled in at T24	0	0	1	1

PAQLQ(S) total score analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	10	15	12	37
Excluded – patient completed up to T48 but has no PAQLQ(S) for T48	1	0	0	1
Excluded – patient has a final PAQLQ(S) but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	5	2	5	12
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T36 and last PAQLQ(S) does not reach the minimum of 43 weeks to be included in the T48 analysis	2	0	1	3
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. Only has a T0 PAQLQ(S)	0	0	1	1

PAQLQ(S) total score analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	17	16	17	50
Excluded – patient completed up to T24 but has no PAQLQ(S) for T24	1	1	1	3
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. No PAQLQ(S) was filled in at T24	0	0	1	1

PACQLQ activity limitations domain score analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	11	15	12	38
Excluded – patient does not have a final PACQLQ and did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	0	0	1	1
Excluded – patient has a final PACQLQ but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	5	2	4	11
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T36 and last PACQLQ does not reach the minimum of 43 weeks to be included in the T48 analysis	2	0	1	3
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. Only has a T0 PACQLQ	0	0	1	1

PACQLQ activity limitations domain score analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	17	14	16	47
Excluded – patient completed up to T24 but has no PACQLQ for T24	1	1	2	4
Excluded – patient has a T0 and T24 PACQLQ but has a missing answer in the activity limitations domain at the T0 visit	0	2	0	2
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. No PACQLQ was filled in at T24	0	0	1	1

PACQLQ emotional functioning domain score analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	11	15	12	38
Excluded – patient does not have a final PACQLQ and did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	0	0	1	1
Excluded – patient has a final PACQLQ but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	5	2	4	11
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T36 and last PACQLQ does not reach the minimum of 43 weeks to be included in the T48 analysis	2	0	1	3
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. Only has a T0 PACQLQ	0	0	1	1

PACQLQ emotional functioning domain score analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	17	16	16	49
Excluded – patient completed up to T24 but has no PACQLQ for T24	1	1	2	4
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24. No PACQLQ was filled in at T24	0	0	1	1

Time from randomisation to first exacerbation requiring treatment with a short course of oral corticosteroids analysis set inclusion/exclusions with reasons

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	19	23	21	63

Number of school days missed intention-to-treat analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	11	15	11	37
Excluded – patient completed the trial up to T48 but has missing number of school days missed data at T48 visit	0	0	1	1
Excluded – patient has number of school days missed data past T24 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	4	2	4	10
Excluded – patient has number of school days missed data past T36 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	1	0	1	2
Excluded – patient has number of school days missed data only up to T24 as withdrew before T36	2	0	1	3
Excluded – patient has number of school days missed data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8 so has no number of school days missed data	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24	0	0	1	1

Number of school days missed intention-to-treat analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	18	17	19	54
Excluded – patient has number of school days missed data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8 so has no number of school days missed data	0	1	1	2

Number of school days missed per-protocol analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	9	11	8	28
Excluded – patient has missing number of school days missed data at T48 visit and has missing number of missed doses data for at least one visit	0	0	1	1
Excluded – patient has number of school days missed data past T24 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	4	2	4	10
Excluded – patient has number of school days missed data past T36 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	1	0	1	2
Excluded – patient has number of school days missed data up to T48 but did not take > 70% of tablets	0	0	1	1
Excluded – patient has number of school days missed data up to T48 but has missing number of missed doses data for at least one visit	2	4	2	8
Excluded – patient has number of school days missed data only up to T24 as withdrew before T36	2	0	1	3
Excluded – patient has number of school days missed data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24 and has missing number of missed doses data for the T24 visit	0	0	1	1
Excluded – patient withdrew before T8 so has no number of school days missed data	0	1	1	2

Number of school days missed per-protocol analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	15	13	16	44
Excluded – patient has number of school days missed data up to T24 but did not take > 70% of inhalers	0	1	0	1
Excluded – patient has number of school days missed data up to T24 but did not take > 70% of tablets	0	0	1	1
Excluded – patient has number of school days missed data up to T24 but has missing number of missed doses data for at least one visit	3	3	1	7
Excluded – patient has number of school days missed data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24 and has missing number of missed doses data for the T24 visit	0	0	1	1
Excluded – patient withdrew before T8 so has no number of school days missed data	0	1	1	2

Number of hospital admissions missed intention-to-treat analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	11	15	11	37
Excluded – patient completed the trial up to T48 but has missing number of hospital admissions data at T48 visit	0	0	1	1
Excluded – patient has number of hospital admissions data past T24 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	4	2	4	10
Excluded – patient has number of hospital admissions data past T36 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	1	0	1	2
Excluded – patient has number of hospital admissions data only up to T24 as withdrew before T36	2	0	1	3
Excluded – patient has number of hospital admissions data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8 so has no number of hospital admissions data	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24	0	0	1	1

Number of hospital admissions missed intention-to-treat analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	18	17	19	54
Excluded – patient has number of hospital admissions data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8 so has no number of hospital admissions data	0	1	1	2

Number of hospital admissions missed per-protocol analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	9	11	8	28
Excluded – patient has number of hospital admissions data past T24 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	4	2	4	10
Excluded – patient has number of hospital admissions data past T36 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	1	0	1	2
Excluded – patient has number of hospital admissions data up to T48 but did not take > 70% of tablets	0	0	1	1
Excluded – patient has number of hospital admissions data up to T48 but has missing number of missed doses data for at least one visit	2	4	3	9
Excluded – patient has number of hospital admissions data only up to T24 as withdrew before T36	2	0	1	3
Excluded – patient has number of hospital admissions data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24 and has missing number of missed doses data for the T24 visit	0	0	1	1
Excluded – patient withdrew before T8 so has no number of hospital admissions data	0	1	1	2

Number of hospital admissions missed per-protocol analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	15	13	16	44
Excluded – patient has number of hospital admissions data up to T24 but did not take > 70% of inhalers	0	1	0	1
Excluded – patient has number of hospital admissions data up to T24 but did not take > 70% of tablets	0	0	1	1
Excluded – patient has number of hospital admissions data up to T24 but has missing number of missed doses data for at least one visit	3	3	1	7
Excluded – patient has number of hospital admissions data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24 and has missing number of missed doses data for the T24 visit	0	0	1	1
Excluded – patient withdrew before T8 so has no number of hospital admissions data	0	1	1	2

Amount of rescue beta-2 agonist therapy prescribed analysis set inclusion/exclusions with reasons: T48

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	11	14	12	37
Excluded – patient completed trial up to T48 but has missing number of beta-2 agonists data for T24 visit	0	1	0	1
Excluded – patient has number of beta-2 agonists data past T24 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	4	2	4	10
Excluded – patient has number of beta-2 agonists data past T36 but did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	1	0	1	2
Excluded – patient has number of beta-2 agonists data only up to T24 as withdrew before T36	2	0	1	3
Excluded – patient has number of beta-2 agonists data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8 so has no number of beta-2 agonists data	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24	0	0	1	1

Amount of rescue beta-2 agonist therapy prescribed analysis set inclusion/exclusions with reasons: T24

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	18	16	19	53
Excluded – patient completed trial up to T48 but has missing number of beta-2 agonists data for T24 visit	0	1	0	1
Excluded – patient has number of beta-2 agonists data only up to T8 as withdrew before T24	1	5	1	7
Excluded – patient withdrew before T8 so has no number of beta-2 agonists data	0	1	1	2

Forced expiratory volume in 1 second per cent predicted analysis set inclusion/exclusions with reasons

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	8	13	9	30
Excluded – patient did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	5	2	5	12
Excluded – patient had no spirometry at both the T0 and the T48 visits	0	1	0	1
Excluded – patient has FEV₁(%) data at T0 but missing FEV₁(%) data at T48	1	0	0	1
Excluded – patient has FEV₁(%) data at T0 but spirometry not carried out at T48	1	0	1	2
Excluded – patient has FEV₁(%) data at T48 but missing FEV₁(%) data at T0	0	1	0	1
Excluded – patient has FEV₁(%) data at T48 but spirometry not carried out at T0	1	0	2	3
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T36	2	0	1	3
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24	0	0	1	1

Forced vital capacity per cent predicted analysis set inclusion/exclusions with reasons

Analysis status	Treatment
Analysis status	Fluticasone (n = 19)	Fluticasone plus salmeterol (n = 23)	Fluticasone plus montelukast (n = 21)	Total (n = 63)
Included	8	13	9	30
Excluded – patient did not reach the minimum of 43 weeks for a T48 visit because of early closure of the trial	5	2	5	12
Excluded – patient had no spirometry at both the T0 and the T48 visits	0	1	0	1
Excluded – patient has FVC(%) data at T0 but missing FVC(%) data at T48	1	0	0	1
Excluded – patient has FVC(%) data at T0 but spirometry not carried out at T48	1	0	1	2
Excluded – patient has FVC(%) data at T48 but missing FVC(%) data at T0	0	1	0	1
Excluded – patient has FVC(%) data at T48 but spirometry not carried out at T0	1	0	2	3
Excluded – patient withdrew before T24	1	5	1	7
Excluded – patient withdrew before T36	2	0	1	3
Excluded – patient withdrew before T8	0	1	1	2
Excluded – patient withdrew from trial treatment before T8, had no T8 visit but agreed to have data collected at T24	0	0	1	1

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Lenney W, McKay AJ, Tudur Smith C, et al.; MASCOT Study Group. Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety. Southampton (UK): NIHR Journals Library; 2013 Feb. (Health Technology Assessment, No. 17.4.) Appendix 6, Reasons for exclusion of participants from outcome analyses.
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Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety.

Appendix 6Reasons for exclusion of participants from outcome analyses

Primary outcome intention-to-treat analysis set inclusion/exclusions with reasons: T48

Primary outcome intention-to-treat analysis set inclusion/exclusions with reasons: T24

Primary outcome per-protocol analysis set inclusion/exclusions with reasons: T48

Primary outcome per-protocol analysis set inclusion/exclusions with reasons: T24

PAQLQ(S) activity limitations domain score analysis set inclusion/exclusions with reasons: T48

PAQLQ(S) activity limitations domain score analysis set inclusion/exclusions with reasons: T24

PAQLQ(S) activity limitations domain score analysis set inclusion/exclusions with reasons: T24

PAQLQ(S) symptoms domain score analysis set inclusion/exclusions with reasons: T48

PAQLQ(S) symptoms domain score analysis set inclusion/exclusions with reasons: T24

PAQLQ(S) total score analysis set inclusion/exclusions with reasons: T48

PAQLQ(S) total score analysis set inclusion/exclusions with reasons: T24

PACQLQ activity limitations domain score analysis set inclusion/exclusions with reasons: T48

PACQLQ activity limitations domain score analysis set inclusion/exclusions with reasons: T24

PACQLQ emotional functioning domain score analysis set inclusion/exclusions with reasons: T48

PACQLQ emotional functioning domain score analysis set inclusion/exclusions with reasons: T24

Time from randomisation to first exacerbation requiring treatment with a short course of oral corticosteroids analysis set inclusion/exclusions with reasons

Number of school days missed intention-to-treat analysis set inclusion/exclusions with reasons: T48

Number of school days missed intention-to-treat analysis set inclusion/exclusions with reasons: T24

Number of school days missed per-protocol analysis set inclusion/exclusions with reasons: T48

Number of school days missed per-protocol analysis set inclusion/exclusions with reasons: T24

Number of hospital admissions missed intention-to-treat analysis set inclusion/exclusions with reasons: T48

Number of hospital admissions missed intention-to-treat analysis set inclusion/exclusions with reasons: T24

Number of hospital admissions missed per-protocol analysis set inclusion/exclusions with reasons: T48

Number of hospital admissions missed per-protocol analysis set inclusion/exclusions with reasons: T24

Amount of rescue beta-2 agonist therapy prescribed analysis set inclusion/exclusions with reasons: T48

Amount of rescue beta-2 agonist therapy prescribed analysis set inclusion/exclusions with reasons: T24

Forced expiratory volume in 1 second per cent predicted analysis set inclusion/exclusions with reasons

Forced vital capacity per cent predicted analysis set inclusion/exclusions with reasons

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