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Table 4 Relationships between primary endpoints and secondary endpoints

From: Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov

 

Trials with severe patients

Trials with non-severe patients

Primary endpoints

Primary endpoints

Improvementa

(N=45)

Worseninga

(N=39)

Unknowna

(N=13)

Improvementa

(N=97)

Worseninga

(N=117)

Unknowna

(N=51)

Secondary endpoints

Binary

 Improvement

18 (40.0%)

7 (17.9%)

13 (100.0%)

29 (29.9%)

28 (23.9%)

8 (15.7%)

 Recovery

3 (6.7%)

2 (5.1%)

13 (100.0%)

5 (5.2%)

2 (1.7%)

51 (100.0%)

 Mortality

27 (60.0%)

26 (66.7%)

4 (30.8%)

43 (44.3%)

49 (41.9%)

24 (47.1%)

Time-to-event

 Improvement

20 (44.4%)

14 (35.9%)

5 (38.5%)

29 (29.9%)

31 (26.5%)

8 (15.7%)

 Recovery

3 (6.7%)

4 (10.3%)

2 (15.4%)

8 (8.2%)

5 (4.3%)

4 (7.8%)

 Mortality

7 (15.6%)

9 (23.1%)

3 (23.1%)

10 (10.3%)

12 (10.3%)

5 (9.8%)

Ordinal

 One time point

9 (20.0%)

6 (15.4%)

2 (15.4%)

10 (10.3%)

20 (17.1%)

6 (11.8%)

 Longitudinal

7 (15.6%)

10 (25.6%)

1 (7.7%)

7 (7.2%)

12 (10.3%)

2 (3.9%)

  1. aBinary and time-to-event endpoints of primary endpoints