Table 2. Open in new tab Incidence of...

(Sub)group	Overall Study Population	Immunocompromised Population
Overall	n = 633	n = 664	n = 643	n = 1307	n = 35	n = 32	n = 32	n = 64
Events, No.	113	98	102	200	6	4	3	7
Cumulative incidence, % (95% CI)	18.3 (15.5–21.6)	15.1 (12.6–18.1)	16.3 (13.7–19.5)	15.7 (13.8–17.9)	17.2 (8.1–34.4)	12.6 (4.9–30.2)	9.5 (3.2–26.6)	11.0 (5.4–21.8)
Seronegative	n = 246	n = 276	n = 277	n = 553	n = 19	n = 26	n = 23	n = 49
Events, No.	58	40	46	86	3	4	2	6
Cumulative incidence, % (95% CI)	24.4 (19.4–30.4)	14.9 (11.2–19.8)	17.2 (13.2–22.3)	16.1 (13.2–19.5)	16.1 (5.5–42.1)	15.6 (6.1–36.3)	8.9 (2.3–31.2)	12.4 (5.8–25.6)
Seropositive	n = 342	n = 331	n = 321	n = 652	n = 15	n = 4	n = 6	n = 10
Events, No.	49	52	46	98	3	0	0	0
Cumulative incidence, % (95% CI)	14.6 (11.3–18.9)	16.0 (12.5–20.5)	14.7 (11.2–19.2)	15.4 (12.8–18.4)	20.0 (6.9–50.0)	0	0	0
Sero-undetermined	n = 45	n = 57	n = 45	n = 102	n = 1	n = 2	n = 3	n = 5
Events, No.	6	6	10	16	0	0	1	1
Cumulative incidence, % (95% CI)	13.5 (6.3–27.5)	10.9 (5.0–22.7)	22.6 (12.9–37.9)	16.2 (10.2–25.0)	0	0	33.3 (5.5–94.6)	20.0 (3.1–79.6)

(Sub)group

Overall Study Population

Immunocompromised Population

Placebo

CAS + IMD 2.4 g IV

CAS + IMD 8.0 g IV

Combined Doses

Placebo

CAS + IMD 2.4 g IV

CAS + IMD 8.0 g IV

Combined Doses

Overall

n = 633

n = 664

n = 643

n = 1307

n = 35

n = 32

n = 64

Events, No.

113

102

200

Cumulative incidence, % (95% CI)

18.3
(15.5–21.6)

15.1
(12.6–18.1)

16.3
(13.7–19.5)

15.7
(13.8–17.9)

17.2
(8.1–34.4)

12.6
(4.9–30.2)

9.5
(3.2–26.6)

11.0
(5.4–21.8)

Seronegative

n = 246

n = 276

n = 277

n = 553

n = 19

n = 26

n = 23

n = 49

Events, No.

Cumulative incidence, % (95% CI)

24.4
(19.4–30.4)

14.9
(11.2–19.8)

17.2
(13.2–22.3)

16.1
(13.2–19.5)

16.1
(5.5–42.1)

15.6
(6.1–36.3)

8.9
(2.3–31.2)

12.4
(5.8–25.6)

Seropositive

n = 342

n = 331

n = 321

n = 652

n = 15

n = 4

n = 6

n = 10

Events, No.

Cumulative incidence, % (95% CI)

14.6
(11.3–18.9)

16.0
(12.5–20.5)

14.7
(11.2–19.2)

15.4
(12.8–18.4)

20.0
(6.9–50.0)

Sero-undetermined

n = 45

n = 57

n = 45

n = 102

n = 1

n = 2

n = 3

n = 5

Events, No.

Cumulative incidence, % (95% CI)

13.5
(6.3–27.5)

10.9
(5.0–22.7)

22.6
(12.9–37.9)

16.2
(10.2–25.0)

33.3
(5.5–94.6)

20.0
(3.1–79.6)

(Sub)group	Overall Study Population	Immunocompromised Population
Overall	n = 633	n = 664	n = 643	n = 1307	n = 35	n = 32	n = 32	n = 64
Events, No.	113	98	102	200	6	4	3	7
Cumulative incidence, % (95% CI)	18.3 (15.5–21.6)	15.1 (12.6–18.1)	16.3 (13.7–19.5)	15.7 (13.8–17.9)	17.2 (8.1–34.4)	12.6 (4.9–30.2)	9.5 (3.2–26.6)	11.0 (5.4–21.8)
Seronegative	n = 246	n = 276	n = 277	n = 553	n = 19	n = 26	n = 23	n = 49
Events, No.	58	40	46	86	3	4	2	6
Cumulative incidence, % (95% CI)	24.4 (19.4–30.4)	14.9 (11.2–19.8)	17.2 (13.2–22.3)	16.1 (13.2–19.5)	16.1 (5.5–42.1)	15.6 (6.1–36.3)	8.9 (2.3–31.2)	12.4 (5.8–25.6)
Seropositive	n = 342	n = 331	n = 321	n = 652	n = 15	n = 4	n = 6	n = 10
Events, No.	49	52	46	98	3	0	0	0
Cumulative incidence, % (95% CI)	14.6 (11.3–18.9)	16.0 (12.5–20.5)	14.7 (11.2–19.2)	15.4 (12.8–18.4)	20.0 (6.9–50.0)	0	0	0
Sero-undetermined	n = 45	n = 57	n = 45	n = 102	n = 1	n = 2	n = 3	n = 5
Events, No.	6	6	10	16	0	0	1	1
Cumulative incidence, % (95% CI)	13.5 (6.3–27.5)	10.9 (5.0–22.7)	22.6 (12.9–37.9)	16.2 (10.2–25.0)	0	0	33.3 (5.5–94.6)	20.0 (3.1–79.6)

Table 2.

Open in new tab

Incidence of Death or Mechanical Ventilation Events Through Day 29

(Sub)group	Overall Study Population				Immunocompromised Population
(Sub)group	Placebo	CAS + IMD 2.4 g IV	CAS + IMD 8.0 g IV	Combined Doses	Placebo	CAS + IMD 2.4 g IV	CAS + IMD 8.0 g IV	Combined Doses
Overall	n = 633	n = 664	n = 643	n = 1307	n = 35	n = 32	n = 32	n = 64
Events, No.	113	98	102	200	6	4	3	7
Cumulative incidence, % (95% CI)	18.3 (15.5–21.6)	15.1 (12.6–18.1)	16.3 (13.7–19.5)	15.7 (13.8–17.9)	17.2 (8.1–34.4)	12.6 (4.9–30.2)	9.5 (3.2–26.6)	11.0 (5.4–21.8)
Seronegative	n = 246	n = 276	n = 277	n = 553	n = 19	n = 26	n = 23	n = 49
Events, No.	58	40	46	86	3	4	2	6
Cumulative incidence, % (95% CI)	24.4 (19.4–30.4)	14.9 (11.2–19.8)	17.2 (13.2–22.3)	16.1 (13.2–19.5)	16.1 (5.5–42.1)	15.6 (6.1–36.3)	8.9 (2.3–31.2)	12.4 (5.8–25.6)
Seropositive	n = 342	n = 331	n = 321	n = 652	n = 15	n = 4	n = 6	n = 10
Events, No.	49	52	46	98	3	0	0	0
Cumulative incidence, % (95% CI)	14.6 (11.3–18.9)	16.0 (12.5–20.5)	14.7 (11.2–19.2)	15.4 (12.8–18.4)	20.0 (6.9–50.0)	0	0	0
Sero-undetermined	n = 45	n = 57	n = 45	n = 102	n = 1	n = 2	n = 3	n = 5
Events, No.	6	6	10	16	0	0	1	1
Cumulative incidence, % (95% CI)	13.5 (6.3–27.5)	10.9 (5.0–22.7)	22.6 (12.9–37.9)	16.2 (10.2–25.0)	0	0	33.3 (5.5–94.6)	20.0 (3.1–79.6)

(Sub)group	Overall Study Population				Immunocompromised Population
(Sub)group	Placebo	CAS + IMD 2.4 g IV	CAS + IMD 8.0 g IV	Combined Doses	Placebo	CAS + IMD 2.4 g IV	CAS + IMD 8.0 g IV	Combined Doses
Overall	n = 633	n = 664	n = 643	n = 1307	n = 35	n = 32	n = 32	n = 64
Events, No.	113	98	102	200	6	4	3	7
Cumulative incidence, % (95% CI)	18.3 (15.5–21.6)	15.1 (12.6–18.1)	16.3 (13.7–19.5)	15.7 (13.8–17.9)	17.2 (8.1–34.4)	12.6 (4.9–30.2)	9.5 (3.2–26.6)	11.0 (5.4–21.8)
Seronegative	n = 246	n = 276	n = 277	n = 553	n = 19	n = 26	n = 23	n = 49
Events, No.	58	40	46	86	3	4	2	6
Cumulative incidence, % (95% CI)	24.4 (19.4–30.4)	14.9 (11.2–19.8)	17.2 (13.2–22.3)	16.1 (13.2–19.5)	16.1 (5.5–42.1)	15.6 (6.1–36.3)	8.9 (2.3–31.2)	12.4 (5.8–25.6)
Seropositive	n = 342	n = 331	n = 321	n = 652	n = 15	n = 4	n = 6	n = 10
Events, No.	49	52	46	98	3	0	0	0
Cumulative incidence, % (95% CI)	14.6 (11.3–18.9)	16.0 (12.5–20.5)	14.7 (11.2–19.2)	15.4 (12.8–18.4)	20.0 (6.9–50.0)	0	0	0
Sero-undetermined	n = 45	n = 57	n = 45	n = 102	n = 1	n = 2	n = 3	n = 5
Events, No.	6	6	10	16	0	0	1	1
Cumulative incidence, % (95% CI)	13.5 (6.3–27.5)	10.9 (5.0–22.7)	22.6 (12.9–37.9)	16.2 (10.2–25.0)	0	0	33.3 (5.5–94.6)	20.0 (3.1–79.6)

Abbreviations: CAS + IMD, casirivimab plus imdevimab; CI, confidence interval; IV, intravenous.

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