Summary of TEAEs
| TEAEs, n (%) . | CAD cohort (N = 13) . | Number of events . | wAIHA cohort (N = 11) . | Number of events . |
|---|---|---|---|---|
| Any TEAE | 13 (100.0) | 179 | 10 (90.9) | 138 |
| Reported in ≥20% of patients in respective cohort | ||||
| Diarrhea | 5 (38.5) | 9 | — | — |
| Headache | 4 (30.8) | 6 | — | — |
| Hypertension | 4 (30.8) | 6 | — | — |
| Nausea | 4 (30.8) | 6 | — | — |
| Vitamin B12 deficiency | 4 (30.8) | 4 | — | — |
| Dizziness | 3 (23.1) | 7 | — | — |
| Contusion | 3 (23.1) | 5 | — | — |
| Fatigue | 3 (23.1) | 5 | — | — |
| Constipation | 3 (23.1) | 3 | — | — |
| Decreased appetite | 3 (23.1) | 3 | — | — |
| Fall | 3 (23.1) | 3 | — | — |
| Viral upper respiratory tract infection | 3 (23.1) | 3 | — | — |
| Pyrexia | — | — | 4 (36.4) | 6 |
| Injection site pruritus | — | — | 3 (27.3) | 17 |
| Dyspnea | — | — | 3 (27.3) | 4 |
| Cough | — | — | 3 (27.3) | 3 |
| TEAEs at least possibly related to pegcetacoplan | 9 (69.2) | 27∗ | 8 (72.7) | 34† |
| Serious TEAEs | 5 (38.5) | 8 | 5 (45.5) | 5 |
| Serious TEAEs at least possibly related to pegcetacoplan | 0 | 0 | 0 | 0 |
| TEAESI | 10 (76.9) | 37 | 9 (81.8) | 53 |
| TEAESIs at least possibly related to pegcetacoplan | 5 (38.5) | 6 | 5 (45.5) | 25 |
| TEASIs of infection | 7 (53.8) | 13 | 6 (54.5) | 10 |
| Viral upper respiratory tract infection | 3 (23.1) | 3 | 2 (18.2) | 4 |
| Pneumonia | 2 (15.4) | 2 | 1 (9.1) | 1 |
| Upper respiratory tract infection | 1 (7.7) | 1 | 2 (18.2) | 2 |
| Urinary tract infection | 2 (15.4) | 2 | 0 | 0 |
| Fungal infection | 1 (7.7) | 1 | 0 | 0 |
| Incision site abscess | 1 (7.7) | 1 | 0 | 0 |
| Mastitis | 1 (7.7) | 1 | 0 | 0 |
| Oral candidiasis | 1 (7.7) | 1 | 0 | 0 |
| Oral fungal infection | 1 (7.7) | 1 | 0 | 0 |
| Bronchitis | 0 | 0 | 1 (9.1) | 1 |
| Ear infection | 0 | 0 | 1 (9.1) | 1 |
| Influenza | 0 | 0 | 1 (9.1) | 1 |
| TEAEs leading to study drug discontinuation or study withdrawal | 2 (15.4) | 3 | 3 (27.3) | 3 |
| TEAEs, n (%) . | CAD cohort (N = 13) . | Number of events . | wAIHA cohort (N = 11) . | Number of events . |
|---|---|---|---|---|
| Any TEAE | 13 (100.0) | 179 | 10 (90.9) | 138 |
| Reported in ≥20% of patients in respective cohort | ||||
| Diarrhea | 5 (38.5) | 9 | — | — |
| Headache | 4 (30.8) | 6 | — | — |
| Hypertension | 4 (30.8) | 6 | — | — |
| Nausea | 4 (30.8) | 6 | — | — |
| Vitamin B12 deficiency | 4 (30.8) | 4 | — | — |
| Dizziness | 3 (23.1) | 7 | — | — |
| Contusion | 3 (23.1) | 5 | — | — |
| Fatigue | 3 (23.1) | 5 | — | — |
| Constipation | 3 (23.1) | 3 | — | — |
| Decreased appetite | 3 (23.1) | 3 | — | — |
| Fall | 3 (23.1) | 3 | — | — |
| Viral upper respiratory tract infection | 3 (23.1) | 3 | — | — |
| Pyrexia | — | — | 4 (36.4) | 6 |
| Injection site pruritus | — | — | 3 (27.3) | 17 |
| Dyspnea | — | — | 3 (27.3) | 4 |
| Cough | — | — | 3 (27.3) | 3 |
| TEAEs at least possibly related to pegcetacoplan | 9 (69.2) | 27∗ | 8 (72.7) | 34† |
| Serious TEAEs | 5 (38.5) | 8 | 5 (45.5) | 5 |
| Serious TEAEs at least possibly related to pegcetacoplan | 0 | 0 | 0 | 0 |
| TEAESI | 10 (76.9) | 37 | 9 (81.8) | 53 |
| TEAESIs at least possibly related to pegcetacoplan | 5 (38.5) | 6 | 5 (45.5) | 25 |
| TEASIs of infection | 7 (53.8) | 13 | 6 (54.5) | 10 |
| Viral upper respiratory tract infection | 3 (23.1) | 3 | 2 (18.2) | 4 |
| Pneumonia | 2 (15.4) | 2 | 1 (9.1) | 1 |
| Upper respiratory tract infection | 1 (7.7) | 1 | 2 (18.2) | 2 |
| Urinary tract infection | 2 (15.4) | 2 | 0 | 0 |
| Fungal infection | 1 (7.7) | 1 | 0 | 0 |
| Incision site abscess | 1 (7.7) | 1 | 0 | 0 |
| Mastitis | 1 (7.7) | 1 | 0 | 0 |
| Oral candidiasis | 1 (7.7) | 1 | 0 | 0 |
| Oral fungal infection | 1 (7.7) | 1 | 0 | 0 |
| Bronchitis | 0 | 0 | 1 (9.1) | 1 |
| Ear infection | 0 | 0 | 1 (9.1) | 1 |
| Influenza | 0 | 0 | 1 (9.1) | 1 |
| TEAEs leading to study drug discontinuation or study withdrawal | 2 (15.4) | 3 | 3 (27.3) | 3 |
N, number of patients in safety set; n, number of patients with an event.
Related events were headache (3 unique events); fatigue (2 unique events); and nausea, infusion site pain, injection site erythema, injection site pain, injection site pruritus, injection site reaction, injection site swelling, malaise, contusion, neutrophil count decreased, white blood cell count decreased, decreased appetite, dizziness, nasal congestion, lichenoid keratosis, rash maculo-papular, skin warm, and Raynaud phenomenon (1 unique event each).
Related events included injection site pruritus (3 unique events); injection site erythema and pyrexia (2 unique events each); injection site bruising, fatigue, injection site reaction, edema peripheral, arthropod bite, hyponatremia, flushing, and pallor (1 unique event each).