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Table 3 Responses to questionnaire on modified package leaflet (oral contraceptives with placebo comparison)

From: Understanding adverse drug reactions in package leaflets – an exploratory survey among health care professionals

Extract of questionnaire
Frequency of side effects that were reported in a clinical trial on norgestimate/ ethinylestradiol (e.g. Amicette®) with 462 participants:
  Norgestimate/ethinylestradiol Placebo
 Headache 18.4 % 20.5 %
 Painful or unusual periods 10.1 % 9.0 %
 Weight gain 2.2 % 2.1 %
Question 1: If 100 women take this oral contraceptive – in how many women does the intake of this oral contraceptive cause (1) headache (2) painful or unusual periods (3) weight gain?a
 Responses (No) None Lower frequency than listed in package leaflet Same frequency as listed in package leaflet Higher frequency than listed in package leaflet No response
 Format free text
 Group 2 (n = 27) Health science students 0 (1): 7 (26 %) (1): 12 (44 %) (1): 3 (11 %) (1): 5 (19 %)
0 (2): 6 (22 %) (2): 13 (48 %) (2): 6 (22 %) (2): 2 (7 %)
0 (3): 7 (26 %) (3): 13 (48 %) (3): 2 (7 %) (3): 5 (19 %)
Question 2: If 100 women do not take an oral contraceptive – in how many of them does (1) headache (2) painful or unusual periods (3) weight gain occur?b
 Responses (No) None Lower frequency than listed in package leaflet Same frequency as listed in package leaflet Higher frequency than listed in package leaflet No response
 Format free text
 Group 2 (n = 27) Health science students 0 (1): 7 (26 %) (1): 12 (44 %) (1): 3 (11 %) (1): 5 (19 %)
0 (2): 6 (22 %) (2): 13 (48 %) (2): 4 (15 %) (2): 4 (15 %)
0 (3): 6 (22 %) (3): 13 (48 %) (3): 3 (11 %) (3): 5 (19 %)
  1. aPossible answers: “None” is the correct answer. Since we have not provided any p-values for this table and therefore statistical significance cannot be identified, “1” would also be correct in part (2) and accepted in (3). Due to it being free text, missing responses were seen as a sign of non-participation
  2. bPossible answers: Whether women not taking oral contraceptives are equal to women taking placebo depends on placebo and nocebo effects. Therefore, all answers except “none” were accepted. Due to it being free text, missing responses were seen as a sign of non-participation