Table 1.

Number (percentage) of respondents (all, industry and other) that considered the common data elements-related questions important^a with p-values of Pearson ${\chi }^2$ tests for differences between industry and the other stakeholders

	All (N = 73)	Industry (N = 42)	Other (N = 31)	P-value
Medication: which of the following details with regard to the medicinal product to treat the disease of interest should be captured?
Dosage	70 (96)	40 (95)	30 (97)	0.74
Substance name	66 (90)	40 (95)	26 (84)	0.10
Reason for stop/switch to other product registered	65 (89)	39 (93)	26 (84)	0.22
Start and stop date	61 (84)	35 (83)	26 (84)	0.95
Duration of the treatment	49 (67)	25 (60)	24 (77)	0.11
ATCb classification	33 (45)	14 (33)	19 (61)	0.02
Pregnancy: if women of childbearing potential are captured in the registry, how important is the collection of the following data if a woman becomes pregnant?c
Exposure during pregnancyd	64 (90)	42 (100)	22 (76)	<0.01
Outcome of pregnancyd	64 (90)	40 (95)	24 (83)	0.20
Trimester during exposuree,f	58 (84)	36 (88)	22 (79)	0.61
Follow-up teratogenic eventsd,g	58 (84)	35 (88)	23 (79)	0.26
Follow-up childd,g	55 (80)	34 (85)	21 (72)	0.12
Follow-up mothere,h	51 (75)	33 (80)	18 (67)	0.25
Birth weightf,g	43 (63)	23 (58)	20 (71)	0.06
Safety outcomes: which adverse drug events should be collected?
Adverse events of special interest	47 (64)	27 (64)	20 (65)	0.98
Serious adverse events	45 (62)	24 (57)	21 (68)	0.36
All adverse events	31 (42)	18 (43)	13 (42)	0.94
For adverse events potentially related to medicinal products the following should be recordedc
Severity of the event	71 (97)	41 (98)	30 (97)	0.97
Duration of the event	62 (85)	34 (81)	28 (90)	0.74
A causality assessmente	61 (85)	38 (90)	23 (77)	0.30

^aAn element was considered important if ≥80% of the respondents gave it a score of important or very important

^bATC classification: Anatomical Therapeutic Chemical classification

^cQuestion assessed using a Likert scale. See ESM, for additional figures of all answers to the Likert scales

^dTwo missing from the respondents from the other stakeholders

^eOne missing from the respondents from industry

^fThree missing from the respondents from the other stakeholders

^gTwo missing from the respondents from industry

^hFour missing from the respondents from the other stakeholders