TABLE 2.
| Patient status | Data for patients who received: |
|||
|---|---|---|---|---|
| Placebo | CAS+IMD (2.4 g i.v.) | CAS+IMD (8.0 g i.v.) | CAS+IMD (combined doses) | |
| Patients with negative or borderline baseline neutralizing antibodies | ||||
| No. of patients | 68 | 57 | 53 | 110 |
| Any TEAEb | 21 (30.9) | 20 (35.1) | 16 (30.2) | 36 (32.7) |
| Any grade 3 or 4 TEAE | 14 (20.6) | 14 (24.6) | 12 (22.6) | 26 (23.6) |
| Any treatment-emergent SAE | 21 (30.9) | 20 (35.1) | 12 (22.6) | 32 (29.1) |
| Any treatment-emergent AESI | 0 | 2 (3.5) | 5 (9.4) | 7 (6.4) |
| Any treatment-emergent serious AESI | 0 | 2 (3.5) | 1 (1.9) | 3 (2.7) |
| Any treatment-emergent AESI of infusion-related reactions (grade ≥2) through day 4c | 0 | 2 (3.5) | 4 (7.5) | 6 (5.5) |
| Any treatment-emergent AESI of hypersensitivity reactions (grade ≥2) through day 29 | 0 | 0 | 2 (3.8) | 2 (1.8) |
| Any TEAE leading to study infusion interruptiond | 0 | 0 | 0 | 0 |
| Any TEAE leading to study infusion discontinuatione | 0 | 0 | 0 | 0 |
| Patients with positive baseline neutralizing antibody status | ||||
| No. of patients | 222 | 213 | 208 | 421 |
| Any TEAEb | 38 (17.1) | 34 (16.0) | 37 (17.8) | 71 (16.9) |
| Any grade 3 or 4 TEAE | 28 (12.6) | 22 (10.3) | 23 (11.1) | 45 (10.7) |
| Any treatment-emergent SAE | 36 (16.2) | 29 (13.6) | 33 (15.9) | 62 (14.7) |
| Any treatment-emergent AESI | 1 (0.5) | 4 (1.9) | 3 (1.4) | 7 (1.7) |
| Any treatment-emergent serious AESI | 0 | 0 | 0 | 0 |
| Any treatment-emergent AESI of infusion-related reactions (grade ≥ 2) through day 4c | 1 (0.5) | 3 (1.4) | 2 (1.0) | 5 (1.2) |
| Any treatment-emergent AESI of hypersensitivity reactions (grade ≥ 2) through day 29 | 0 | 1 (0.5) | 1 (0.5) | 2 (0.5) |
| Any TEAE leading to study infusion interruptiond | 0 | 1 (0.5) | 1 (0.5) | 2 (0.5) |
| Any TEAE leading to study infusion discontinuatione | 0 | 0 | 0 | 0 |
Seropositive mFAS presented.
TEAEs collected include treatment-emergent SAEs, AESIs, and grade 3 and 4 TEAEs, as well as ad hoc or voluntarily reported TEAEs by some sites.
Deemed treatment related as per investigator assessment.
Infusion interruption. The administration of the infusion was interrupted before being completed but subsequently was restarted, and the full planned dose was administered.
Infusion discontinuation. The administration of the infusion was stopped before being completed, and the full planned dose was not administered.
AESI, adverse event of special interest; CAS+IMD, casirivimab and imdevimab; i.v., intravenous; SAE, serious adverse event; TEAE, treatment-emergent adverse event.
All data represent number and percent unless otherwise specified.