Table 2 Reporting adverse events for glaucoma trials (n = 79) in the ClinicalTrials.gov and the corresponding publication.

From: Safety reporting in trials on glaucoma interventions registered in ClinicalTrials.gov and corresponding publications

 

ClinicalTrials.gov

Publication

P-value

Reporting rate (n, %)

 

  SAEs

79 (100)

65 (82)

 < .001a

  OAEs

79 (100)

78 (99)

.32a

  Deaths

37 (47)

26 (33)

.07a

AEs reported as zero (n, %)

 

  SAEs

20 (25)

27 (34)

.22a

  OAEs

16 (20)

3 (4)

.001a

  Deaths

26 (33)

18 (23)

.37a

Number of different AEs reported per trial (median, IQR/range)

 

  SAEs

3 (0–8/0–74)

1 (1–4/0–23)

.22b

  OAEs

4 (1–9/0–64)

10.5 (6–15/0–47)

.001b

  Deaths

0 (0–0/0–4)

0 (0–1/0–5)

.37b

Number of patients with AEs per trial (median, IQR/range)

 

  SAEs

2 (0–7/0–74)

2 (1–6/0–74)

.93b

  OAEs

27 (5–95.5/0–507

53 (120.3–124.7/0–555)

.02b

  Deaths

0 (0–0/0–4)

0 (0–1/0–5)

.53b

  1. AE – adverse event, SAE – serious adverse event, OAE – other adverse events, IQR – interquartile range.
  2. aChi-square test.
  3. bMann-Whitney test.