2. Deaths.
| Indication for treatment | Study ID | Follow‐up period (days) | Participants who died | P value | |
| Macrolide N (%) | Placebo N (%) | ||||
| Acute respiratory tract infection | Van Delden 2012 | 71 | 9 (19) | 6 (13) | 0.450 |
| Cancer | Barkhordar 20182 | n/a | 11 (23) | 10 (21) | 0.804 |
| Bergeron 20173 | 730 | 95 (41) | 66 (29) | 0.006 | |
| Cardiovascular disease | Anderson 19994 | 730 | 5 (3) | 4 (3) | 0.720 |
| Berg 2005 | 730 | 10 (4) | 9 (4) | 0.837 | |
| Cercek 2003 | n/a | 23 (3) | 29 (4) | 0.417 | |
| Grayston 2005 | 1424 | 143 (7) | 132 (7) | 0.481 | |
| Gupta 19975 | n/a | 1 (3) | 1 (5) | 0.611 | |
| Gurfinkel 1999 | 30 | 0 | 2 (2) | 0.151 | |
| Gurfinkel 1999 | 90 | 0 | 4 (4) | 0.041 | |
| Gurfinkel 1999 | 180 | 2 (2) | 5 (5) | 0.238 | |
| Ikeoka 20076 | 183 | 2 (5) | 0 | 0.162 | |
| Jespersen 20067 | 949 | 212 (10) | 172 (8) | 0.023 | |
| Jespersen 20068 | 2190 | 497 (23) | 426 (19) | 0.004 | |
| Jespersen 20069 | 3650 | 866 (40) | 815 (37) | 0.055 | |
| Joensen 2008 | 767 | 28 (11) | 26 (10) | 0.693 | |
| Kaehler 2005 | 365 | 1 (1) | 1 (1) | 0.990 | |
| Karlsson 2009 | 548 | 5 (4) | 8 (6) | 0.418 | |
| Kim 200410 | 365 | 2 (3) | 2 (3) | 0.987 | |
| Leowattana 200111 | 90 | 1 (2) | 1 (2) | 0.973 | |
| Neumann 2001 | 365 | 16 (3) | 13 (3) | 0.579 | |
| Sander 200212 | 730 | 4 (3) | 5 (4) | 0.735 | |
| Sinisalo 200213 | 555 | 4 (5) | 1 (1) | 0.172 | |
| Vainas 2005 | 730 | 20 (8) | 25 (10) | 0.396 | |
| Vammen 2001 | 767 | 3 (7) | 2 (4) | 0.541 | |
| Wiesli 2002 | 986 | 1 (5) | 2 (10) | 0.548 | |
| Zahn 2003 | 365 | 28 (6) | 26 (6) | 0.739 | |
| Chronic respiratory disease | Albert 201114 | 344 | 18 (3) | 21 (4) | 0.629 |
| Anthony 201415 | 168 | 2 (5) | 0 | 0.152 | |
| Ballard 201116 | n/a17 | 20 (18) | 24 (22) | 0.458 | |
| Hahn 200618 | n/a | 0 | 1 (5) | 0.280 | |
| Ozdemir 201119 | n/a | 2 (5) | 4 (11) | 0.394 | |
| Seemungal 2008 | 365 | 0 | 1 (2) | 0.328 | |
| Shafuddin 2015 | 420 | 3 (3) | 5 (5) | 0.443 | |
| Uzun 201420 | 365 | 0 | 2 (4) | 0.144 | |
| Vos 201121 | 2555 | 5 (33) | 8 (62) | 0.136 | |
| Gastrointestinal condition | Aly 2007 | n/a | 5 (17) | 6 (20) | 0.739 |
| Berne 2002 | n/a | 2 (6) | 2 (6) | 0.903 | |
| Ehsani 2013 | n/a | 0 | 1 (5) | 0.311 | |
| Gokmen 2012 | 14 | 0 | 1 (4) | 0.302 | |
| Ng 2007 | n/a | 2 (2) | 4 (4) | 0.406 | |
| Nuntnarumit 200622 | n/a | 2 (9) | 0 | 0.148 | |
| Oei 200123 | n/a | 1 (4) | 1 (4) | 1.000 | |
| Reignier 2002 | n/a | 6 (30) | 8 (40) | 0.507 | |
| Robins‐Browne 1983 | 7 | 1 (3) | 1 (3) | 1.000 | |
| HIV | Currier 2000 | 483 | 3 (1) | 7 (2) | 0.201 |
| El‐Sadr 200024 | 386 | 5 (2) | 5 (2) | 0.980 | |
| Jablonowski 1997 | n/a | 1 (< 1) | 7 (2) | 0.033 | |
| Oldfield 1998 | n/a | 38 (45) | 38 (44) | 0.946 | |
| Pierce 1996 | 427/40225 | 107 (32) | 137 (41) | 0.017 | |
| Prevention of childhood mortality | Keenan 2018 | 726 | 4 (< 1) | 1 (< 1) | 0.195 |
| Keenan 2018 | 62127 | 2404 (2) | 2616 (3) | 0.000 | |
| Sepsis | Giamarellos‐Bourboulis 2008 | 28 | 31 (31) | 28 (28) | 0.642 |
| Giamarellos‐Bourboulis 2008 | 90 | 43 (43) | 60 (60) | 0.016 | |
| Giamarellos‐Bourboulis 2014 | 28 | 56 (19) | 51 (17) | 0.648 | |
| Skin and soft tissue complaints | Schwameis 2017 | 30 | 0 | 1 (< 1) | 0.318 |
| Urogynaecological conditions | Kaul 200428 | 801/76429 | 1 (< 1) | 2 (1) | 0.578 |
| Van den Broek 2009 | n/a30 | 1 (< 1) | 2 (< 1) | 0.563 | |
| Van den Broek 2009 | 4231 | 7 (1) | 3 (< 1) | 0.205 | |
Abbreviation: HIV: human immunodeficiency virus. n/a: not available.
1Post‐treatment.
2Death caused by relapse, infection, and other reasons. Relapse caused five and seven deaths in the macrolide and placebo groups, respectively.
3Relapse caused 52 and 23 deaths in the macrolide and placebo groups, respectively.
4Cardiovascular death.
5Cardiovascular death.
6Death caused by respiratory complications of chronic obstructive pulmonary disease or sepsis after limb revascularising surgery.
7All‐cause mortality.
8All‐cause mortality.
9All‐cause mortality. Data obtained by e‐mail correspondence with authors (Winkel 2017 [pers comm]).
10Cardiac death.
11Cardiac death.
12Incomplete reporting of death at 4‐year follow‐up. We contacted the authors but received no reply.
13Death caused by ischaemic heart disease or cancer.
14Death caused by chronic obstructive pulmonary disease, cardiovascular attacks, neoplasm, or other/unknown causes. Report on data from Sadatsafavi 2016, a secondary study of Albert 2011.
15Death caused by bronchopneumonia with underlying coronary artery disease.
16Death caused by hypoxic respiratory failure, confirmed sepsis and/or necrotising enterocolitis, pulmonary haemorrhage, or withdrawal of life support due to intraventricular haemorrhage.
17Data collected at days 3, 5, 7, then weekly for the duration of the study, and at discharge.
18Death caused by asthma‐related cause.
19Death caused by sepsis or necrotising enterocolitis.
20Death caused by respiratory failure due to exacerbation in chronic obstructive pulmonary disease.
21Report on patients that never received open‐label azithromycin. Report on data from Ruttens 2015, a secondary study of Vos 2011.
22Death caused by severe bronchopulmonary dysplasia or from necrotising enterocolitis.
23Death caused by necrotising enterocolitis and septicaemia.
24Death caused by liver failure, cardiovascular disease, cancer, an overdose of methadone, or wasting.
25Follow‐up reported separately for clarithromycin and placebo group.
26Deaths reported within one week of study drug administration.
27Follow‐up period estimated as person‐years (N = 323,302)/total number of children randomised (N = 190,238).
28Deaths caused by trauma.
29Follow‐up period reported separately for azithromycin and placebo groups.
30During pregnancy.
31During six weeks after delivery.