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Table 2 Summary of adverse drug reactions

From: Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea

 

e

n (%)

IMP-related adverse events

95

34 (36.6)

Severity

  Mild

95

34 (36.6)

  Moderate

0

0

  Severe

0

0

Change in treatment schedule

  None

93

33 (35.5)

  Temporarily interrupted

2

1 (1.1)

  Discontinued

0

0

  Prior to first intake

0

0

Classification according to EAACI guideline

  LR

85

32 (34.4)

  SR

9

4 (4.3)

  Grade 0/Nonspecific

1

1 (1.1)

Dose

  300 SQ+

16

13 (14.0)

  600 SQ+

11

11 (11.8)

  3,000 SQ+

24

22 (23.7)

  6,000 SQ+

17

17 (18.3)

  15,000 SQ+

26

15 (16.1)

  Dose unknown

1

1 (1.1)

  1. ADR adverse drug reaction, e number of events, EAACI European Academy of Allergy and Clinical Immunology, n (%) number and percentage of subjects, LR local reactions, SQ+ standardized quality units, SR systemic reactions