Table 2 The individual change in Likert score in 48-items of the KARISMA symptom questionnaire from baseline to end of treatment (at 6 months or date of discontinuation), contrasting the placebo to the group treated with 20 mg of tamoxifen, for all women combined and stratified by menopausal status.

From: Side effects of low-dose tamoxifen: results from a six-armed randomised controlled trial in healthy women

	All (N = 401)		Premenopausal (n = 149)		Postmenopausal (n = 252)		Interaction menopausal status
Group symptom	Mean change 20 to 0 mg (ref.)^a	95% confidence interval	Mean change 20 to 0 mg (ref.)^a	95% confidence interval	Mean change 20 to 0 mg (ref.)^a	95% confidence interval	P value^b
Vasomotor
Hot flashes	0.39	[0.19, 0.59]	0.44	[0.10, 0.79]	0.36	[0.11, 0.60]	0.694
Cold sweats	0.35	[0.20, 0.50]	0.30	[0.06, 0.53]	0.38	[0.19, 0.58]	0.575
Night sweats	0.45	[0.24, 0.67]	0.55	[0.16, 0.95]	0.39	[0.14, 0.64]	0.503
Gynaecological/breast
Vaginal discharge	0.51	[0.35, 0.68]	0.41	[0.10, 0.72]	0.60	[0.41, 0.78]	0.301
Vaginal itching/irritation	0.28	[0.12, 0.43]	0.26	[−0.01, 0.53]	0.29	[0.09, 0.49]	0.850
Vaginal bleeding or spotting	−0.07	[−0.16, 0.02]	−0.09	[−0.32, 0.14]	−0.05	[−0.12, 0.01]	0.785
Vaginal dryness	−0.04	[−0.23, 0.15]	0.18	[−0.07, 0.43]	−0.19	[−0.45, 0.08]	0.050
Problems with urination	0.06	[−0.01, 0.12]	0.06	[−0.08, 0.20]	0.05	[−0.02, 0.12]	0.885
Sensitive/tender breasts	−0.04	[−0.19, 0.10]	−0.28	[−0.56, −0.01]	0.11	[−0.05, 0.27]	0.014
Sexual
Pain or discomfort with intercourse	0.15	[−0.04, 0.33]	0.14	[−0.07, 0.35]	0.14	[−0.13, 0.42]	0.991
Lost interest in sex	0.07	[−0.18, 0.33]	−0.33	[−0.72, 0.07]	0.34	[0.01, 0.67]	0.011
Musculoskeletal
Joint pain	−0.05	[−0.26, 0.15]	−0.13	[−0.43, 0.16]	0.00	[−0.27, 0.27]	0.518
Muscle cramps	0.66	[0.47, 0.86]	0.41	[0.12, 0.70]	0.83	[0.57, 1.08]	0.034
Numbness in hands/ feet	0.01	[−0.11, 0.13]	−0.09	[−0.27, 0.09]	0.08	[−0.08, 0.23]	0.164
Skin/subcutaneous/mucous
Fragile mucous membranes	0.05	[−0.12, 0.22]	0.12	[−0.12, 0.36]	0.00	[−0.24, 0.23]	0.465
Dry mouth	0.12	[0.01, 0.22]	0.15	[−0.03, 0.33]	0.09	[−0.05, 0.23]	0.608
Skin rashes	0.16	[0.02, 0.30]	0.30	[0.04, 0.56]	0.08	[−0.08, 0.24]	0.166
Itching	0.18	[0.05, 0.32]	0.22	[−0.02, 0.47]	0.16	[−0.01, 0.33]	0.674
Hair loss	−0.05	[−0.21, 0.10]	−0.18	[−0.39, 0.04]	0.03	[−0.19, 0.25]	0.183
Metabolism/nutrition
Gained weight	−0.02	[−0.22, 0.18]	−0.11	[−0.44, 0.22]	0.04	[−0.20, 0.28]	0.475
Feeling bloated	0.04	[−0.15, 0.22]	−0.04	[−0.37, 0.29]	0.10	[−0.12, 0.31]	0.496
Swollen arms/legs	0.04	[−0.03, 0.11]	0.07	[−0.04, 0.19]	0.02	[−0.06, 0.10]	0.436
Abdominal obesity	−0.01	[−0.17, 0.15]	−0.01	[−0.26, 0.24]	−0.01	[−0.23, 0.20]	0.989
Gastrointestinal
Diarrhoea	−0.16	[−0.28, −0.03]	−0.21	[−0.43, 0.01]	−0.13	[−0.28, 0.03]	0.558
Constipation	−0.03	[−0.16, 0.10]	−0.11	[−0.33, 0.12]	0.02	[−0.14, 0.18]	0.373
Nausea	−0.06	[−0.18, 0.06]	−0.23	[−0.47, 0.02]	0.04	[−0.09, 0.16]	0.063
Vomiting	−0.07	[−0.15, 0.01]	−0.07	[−0.23, 0.09]	−0.08	[−0.15, 0.00]	0.956
Lack of appetite	0.05	[0.00, 0.09]	0.08	[0.00, 0.16]	0.03	[−0.03, 0.08]	0.296
Change in the way food taste	0.01	[−0.02, 0.04]	0.01	[−0.01, 0.04]	0.01	[−0.04, 0.06]	0.918
Difficulty swallowing	0.00	[−0.06, 0.06]	0.00	[0.00, 0.00]	0.00	[−0.09, 0.10]	0.975
Psychological
Mood swings	0.05	[−0.12, 0.22]	0.00	[−0.30, 0.30]	0.10	[−0.10, 0.30]	0.586
Feeling irritable	0.07	[−0.10, 0.24]	−0.02	[−0.31, 0.26]	0.13	[−0.08, 0.35]	0.381
Feeling nervous	−0.13	[−0.23, −0.02]	−0.17	[−0.36, 0.02]	−0.09	[−0.21, 0.03]	0.466
Feeling sad	−0.12	[−0.28, 0.04]	−0.25	[−0.60, 0.09]	−0.03	[−0.19, 0.12]	0.265
Worrying	0.00	[−0.16, 0.16]	−0.01	[−0.31, 0.29]	0.02	[−0.16, 0.21]	0.855
Lack of energy	−0.07	[−0.25, 0.10]	−0.09	[−0.38, 0.20]	−0.04	[−0.26, 0.17]	0.786
Difficulty concentrating	−0.07	[−0.19, 0.06]	−0.07	[−0.30, 0.16]	−0.05	[−0.20, 0.09]	0.900
Sleeping difficulties	−0.16	[−0.39, 0.08]	−0.12	[−0.50, 0.27]	−0.18	[−0.48, 0.11]	0.780
Feeling drowsy	0.02	[−0.08, 0.11]	−0.04	[−0.21, 0.14]	0.05	[−0.05, 0.16]	0.404
“I don’t look like myself”	0.00	[−0.14, 0.13]	−0.07	[−0.29, 0.15]	0.04	[−0.13, 0.21]	0.445
Nervous system
Pain	−0.18	[−0.40, 0.05]	−0.39	[−0.79, 0.01]	−0.06	[−0.33, 0.21]	0.177
Dizziness	0.04	[−0.11, 0.18]	−0.04	[−0.28, 0.20]	0.09	[−0.08, 0.27]	0.366
Headache	0.08	[−0.11, 0.27]	0.21	[−0.16, 0.57]	0.01	[−0.20, 0.22]	0.365
Heart palpitations	0.03	[−0.09, 0.14]	0.09	[−0.10, 0.27]	−0.01	[−0.16, 0.15]	0.455
Respiratory
Cough	0.01	[−0.15, 0.18]	−0.10	[−0.33, 0.14]	0.08	[−0.15, 0.31]	0.279
Shortness of breath	0.07	[−0.04, 0.18]	0.13	[−0.04, 0.31]	0.04	[−0.11, 0.18]	0.404
Eyes
Sight/eye changes	0.06	[−0.14, 0.26]	0.01	[−0.30, 0.33]	0.08	[−0.17, 0.33]	0.746
Dry eyes	0.06	[−0.11, 0.24]	0.09	[−0.19, 0.37]	0.05	[−0.18, 0.27]	0.801

^aDifference in mean change comparing 20 to 0 mg (ref.) tamoxifen at end of treatment (at 6 months or date of discontinuation).
^bP values for interaction of menopausal status on the effect of tamoxifen.
Significant values are in bold (P < 0.05).

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Table 2 The individual change in Likert score in 48-items of the KARISMA symptom questionnaire from baseline to end of treatment (at 6 months or date of discontinuation), contrasting the placebo to the group treated with 20 mg of tamoxifen, for all women combined and stratified by menopausal status.

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