Table 1 Main results from PAMM regression models

Aortic aneurysm/dissection

Cardiac arrhythmia/sudden cardiac death

Acute toxic liver injury/acute liver failure

All-cause mortality

aHR

[95% CI]

aHR

[95% CI]

aHR

[95% CI]

aHR

[95% CI]

Fluoroquinolone episode (ref. active comparators)

1.07

[1.04;1.09]

1.05

[1.04;1.05]

1.34

[1.30;1.39]

1.23

[1.23;1.24]

Males (ref. females)

3.03

[2.96;3.10]

1.23

[1.22;1.24]

1.38

[1.33;1.42]

1.47

[1.46;1.48]

CCI (ref. 0)

 1–2

1.11

[1.09;1.14]

0.97

[0.96;0.98]

1.10

[1.06;1.14]

1.72

[1.71;1.74]

 3–4

1.10

[1.07;1.14]

0.96

[0.94;0.97]

1.16

[1.09;1.24]

2.33

[2.30;2.35]

 5 + 

1.01

[0.97;1.06]

1.02

[1.00;1.04]

2.91

[2.75;3.09]

4.49

[4.44;4.54]

Drugs dispensed (ref. 0)

 1–3

1.14

[1.07;1.22]

1.19

[1.18;1.21]

1.06

[0.98;1.16]

0.83

[0.80;0.85]

 4–10

1.32

[1.24;1.40]

1.46

[1.44;1.49]

1.28

[1.18;1.38]

1.01

[0.99;1.04]

 11–20

1.46

[1.37;1.54]

1.68

[1.66;1.71]

1.57

[1.45;1.71]

1.32

[1.29;1.35]

 21 + 

1.51

[1.42;1.61]

2.14

[2.10;2.17]

2.19

[2.02;2.38]

2.19

[2.14;2.25]

Hospitalized days (ref. 0)

 1–7

1.10

[1.07;1.13]

1.03

[1.02;1.04]

1.47

[1.40;1.54]

1.33

[1.32;1.34]

 8 + 

1.06

[1.03;1.09]

1.11

[1.10;1.12]

2.71

[2.61;2.83]

2.48

[2.46;2.49]

Cohort entry year (ref. 2014)

 2015

1.02

[0.99;1.06]

0.99

[0.98;1.00]

1.06

[1.01;1.12]

0.96

[0.95;0.97]

 2016

1.06

[1.02;1.10]

0.99

[0.98;1.00]

1.03

[0.98;1.08]

0.97

[0.96;0.98]

 2017

1.13

[1.09;1.17]

0.95

[0.94;0.96]

1.04

[0.99;1.10]

0.96

[0.95;0.97]

 2018

1.27

[1.22;1.31]

0.94

[0.93;0.95]

1.03

[0.98;1.08]

0.95

[0.94;0.95]

Cohort entry quarter (ref. Q1 (January–March)

 Q2 (April–June)

1.02

[0.99;1.05]

1.03

[1.02;1.03]

1.07

[1.02;1.11]

1.03

[1.03;1.04]

 Q3 (July–September)

1.06

[1.03;1.09]

1.02

[1.01;1.03]

1.04

[1.00;1.09]

1.09

[1.08;1.10]

 Q4 (October–December)

1.07

[1.04;1.10]

1.03

[1.02;1.04]

1.06

[1.02;1.11]

1.05

[1.04;1.05]

Outcome-specific additional covariables

 Diabetes mellitus

0.74

[0.72;0.76]

1.03

[1.02;1.03]

1.04

[1.00;1.08]

NA

 CVD

1.93

[1.88;1.98]

1.44

[1.43;1.45]

NA

NA

 Cardiac surgery

1.02

[0.93;1.10]

NA

NA

NA

 COPD

NA

1.14

[1.13;1.15]

NA

NA

 Renal diseases

NA

1.14

[1.13;1.15]

2.48

[2.40;2.57]

NA

 Liver diseases

NA

NA

1.25

[1.20;1.30]

NA

Approximate significance of smooth terms:

edf

p-value

edf

p-value

edf

p-value

edf

p-value

Follow-up

2.96

 < 0.001

2.91

 < 0.001

2.98

 < 0.001

3.00

 < 0.001

Age in years

6.42

 < 0.001

8.27

 < 0.001

4.75

 < 0.001

8.86

 < 0.001