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Table 6 Baseline characteristics of participants subsequently with and without at least 1 Medical adverse event (AE) or serious adverse event (SAE)

From: Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting

 At least 1 Medical SAE/AE
N = 532
Participants without a Medical SAE/AE
N = 1086
Unadjusted ORa (95% CI), p valueAdjusted ORb (95% CI), p value
Baseline characteristicnMedian (25th to 75th centile) or %nMedian (25th to 75th centile) or %  
Maternal age (years)53217.9 (16.9 to 18.9)108617.8 (16.9 to 18.8)1.05 (0.97 to 1.15), 0.226 
Ethnicity    Overall p value = 0.240 
 White background47388.995287.7Ref 
 Mixed background346.4555.11.45 (0.90 to 2.36), 0.130 
 Asian background122.3151.41.69 (0.68 to 4.22), 0.259 
 Black background112.1605.50.65 (0.30 to 1.39), 0.265 
 Other background20.440.41.59 (0.27 to 9.45), 0.609 
Relationship status    Overall p value = 0.847 
 Married81.5121.1Ref 
 Separated519.611410.50.73 (0.26 to 2.06), 0.557 
 Closely involved/boyfriend40776.581575.00.67 (0.32 to 1.80), 0.426 
 Just friends6612.414513.40.67 (0.24 to 1.88), 0.448 
Live with father of baby
 No34971.876376.8Ref 
 Yes13728.223123.21.16 (0.88 to 1.52), 0.285 
Missing46 92   
Family subjective social status5275.7 (5.0 to 7.0)10805.7 (5.0 to 7.0)1.00 (0.93 to 1.07), 0.916 
Personal subjective social status5296.8 (6.0 to 8.0)10826.9 (6.0 to 8.0)0.98 (0.92 to 1.04), 0.439 
NEETc
 No27961.053057.4ref 
 Yes17839.039342.60.98 (0.76 to 1.26), 0.869 
 Not applicable75 163   
Receive any welfare benefits
 No34665.068663.3Ref 
 Yes18635.039836.71.02 (0.81 to 1.30), 0.848 
Missing0 2   
Ever been homeless
 No41978.888581.5Ref 
 Yes11321.220118.51.24 (0.93 to 1.64), 0.146 
Socio-economic status: Index of Multiple Deprivation Scored52839.1 (25.9 to 51.3)107839.2 (24.8 to 52.6)1.01 (0.99 to 1.01), 0.0781.01 (0.998 to 1.01), 0.106
EQ5D-Binary
 Less than perfect health22041.436533.7RefRef
 Perfect health31258.671866.30.73 (0.58 to 0.93), 0.0120.98 (0.74 to 1.29), 0.881
 Not answered0 3   
Self-rated health    Overall p-value = 0.141 
 Excellent866.217716.3Ref 
 Good34564.874068.11.00 (0.73 to 1.36), 0.985 
 Fair9217.316014.71.20 (0.81 to 1.79), 0.359 
 Poor91.790.82.84 (1.02 to 7.95), 0.046 
Limiting long-term illness:
 No41678.292385.0Refref
 Yes11621.816315.01.53 (1.14 to 2.06), 0.0051.37 (1.01 to 1.88), 0.046
Generalized Self-efficacy Scalee52630.0 (27.0 to 33.0)106630.0 (28.0 to 33.0)1.00 (0.97 to 1.02), 0.869 
Adaptive functioningf
Difficulty in at least 1 basic skill
 No37270.381374.9refRef
 Yes15729.727325.11.38 (1.07 to 1.78), 0.0131.18 (0.91 to 1.54), 0.219
Missing3 0   
Adaptive functioningf
Had 3 or less life skills (out of 5)
 No38772.979173.2ref 
 Yes14427.129026.81.11 (0.87 to 1.43), 0.404 
Missing1 5   
Adaptive functioningf
At least 1 burden
 No35467.077772.0RefRef
 Yes17433.030228.01.26 (0.98 to 1.61), 0.0691.09 (0.84 to 1.41), 0.543
Missing3 7   
Substance abuseg5131.3 (0.0 to 2.0)10251.4 (0.0 to 2.0)0.98 (0.91 to 1.06), 0.612 
Antisocial behaviour Score5282.4 (1.0 to 4.0)10812.4 (1.0 to 4.0)1.06 (0.99 to 1.13), 0.0891.01 (0.95 to1.09), 0.689
Social support52685.1 (77.6 to 98.7)107784.8 (77.6 to 98.7)1.00 (0.99 to 1.01), 0.784 
Relationship quality42828.4 (26.0 to 32.0)84928.8 (25.0 to 31.0)1.00 (0.98 to 1.03), 0.825 
Family resources51013.3 (11.0 to 16.0)104113.4 (11.0 to 17.0)0.98 (0.95 to 1.01), 0.145 
Psychological distress/mental health52922.4 (17.0 to 27.0)108021.1 (16.0 to 25.0)1.04 (1.02 to 1.06), < 0.0011.03 (1.01 to 1.05), 0.004
Arm
 Control24345.756752.2RefRef
 Intervention28954.351947.81.32 (1.05 to 1.65), 0.0161.34 (1.07 to 1.70), 0.012
  1. aOR predicts a Social AE and adjusted for site; bAdjusted for site and all other candidate predictors in model; cDefinition of NEET: Not in Education Employment or Training Status (applicable only to those whose academic age is > 16 years at baseline interview); dHigher IMD: Index of Multiple Deprivation score indicated more deprivation; eHigher score indicates higher level of self-efficacy; fHigher score indicates better management of day-to-day lives and routines (for each of the three sub-scales); gCRAFFT screening test for substance-related risks and problems in adolescents;
  2. Odds ratios (ORs) bolded and in italics indicate variable significant at 10% at univariable level and remained so at multivariable level