Table 1.

Characteristics of adverse drug reactions (ADRs)

Characteristic	ADRs		ADRs/MDADsa
	N	%
Seriousness
Non-serious ADRs	5331	96.8	1.45
Serious ADRs	104	1.9	0.03
Not applicableb	71	1.3	0.02
Total	5506	100.0	1.50
Causality
Certain	615	11.2	0.17
Probable/likely	393	7.1	0.11
Possible	3711	67.4	1.01
Not assessable	679	12.3	0.18
Not applicableb	108	2.0	0.03
Total	5506	100.0	1.50
Outcome
Recovered/resolved	3732	67.8	1.02
Recovering/resolving	318	5.8	0.09
Recovered/resolved with sequelae	13	0.2	0.00
Sequelae	1	0.0	0.00
Not recovered/not resolved	266	4.8	0.07
Fatal	0	0.0	0.00
Unknown	1097	19.9	0.30
Not assessable	2	0.0	0.00
Not applicableb	77	1.4	0.02
Total	5506	100.0	1.50
Labellingc
Yes	3342	60.7	0.91
No	1854	33.7	0.50
Equivalentd	127	2.3	0.03
Not applicableb	110	2.0	0.03
Unknown	52	0.9	0.01
Not assessed	20	0.4	0.01
No approval in	1	0.0	0.00
Total	5506	100.0	1.50

MDADs maximum daily administration doses sold, AMP anthroposophic medicinal product

^a× 1 million

^bNot applicable: incorrect use of the AMP, the ADR was reported in terms of lack of effect or similar, or the ADR was evaluated to be causally linked to another AMP that was concomitantly administered in that patient

^cLabelling information on the ADR in the patient information leaflet

^dEquivalent (similar) to the labelling of the ADR in the patient information leaflet