Adverse events
| Event, n (%) . | OD group . | RP group . | ||
|---|---|---|---|---|
| OP OD therapy (n = 37) . | ATP Marstacimab prophylaxis (n = 33) . | OP RP therapy (n = 91) . | ATP Marstacimab prophylaxis (n = 83) . | |
| Any event | 9 (24.3) | 12 (36.4) | 20 (22.0) | 62 (74.7) |
| Treatment related | NA | 4 (12.1)∗ | NA | 19 (22.9)† |
| Reported in ≥5% of participants‡ | ||||
| COVID-19 | 0 | 2 (6.1) | 3 (3.3) | 18 (21.7) |
| Headache | 0 | 1 (3.0) | 0 | 6 (7.2) |
| Contusion | 0 | 0 | 0 | 5 (6.0) |
| Dental caries | 2 (5.4) | 0 | 0 | 4 (4.8) |
| Pruritus | 0 | 2 (6.1) | 0 | 2 (2.4) |
| Upper respiratory tract infection | 0 | 2 (6.1) | 1 (1.1) | 1 (1.2) |
| Joint range of motion decreased | 1 (2.7) | 2 (6.1) | 0 | 0 |
| Any serious event | 1 (2.7)§ | 0 | 2 (2.2)| | 7 (8.4)¶ |
| Treatment related | NA | 0 | NA | 1 (1.2)# |
| Event leading to treatment discontinuation | 0 | 0 | 0 | 1 (1.2)∗∗ |
| Embolic and thrombotic events | 0 | 0 | 1 (1.1)†† | 0 |
| Events of special interest‡‡ | 9 (24.3) | 14 (42.4) | 15 (16.5) | 46 (55.4) |
| Reported in ≥5% of participants | ||||
| COVID-19 | 0 | 2 (6.1) | 3 (3.3) | 19 (22.9) |
| Hemorrhages | 1 (2.7)§ | 0 | 5 (5.5) | 13 (15.7) |
| Hepatic disorders | 7 (18.9) | 7 (21.2) | 3 (3.3) | 4 (4.8) |
| Hypersensitivity§§ | 0 | 2 (6.1) | 2 (2.2) | 6 (7.2) |
| Hypertension | 1 (2.7) | 2 (6.1) | 2 (2.2) | 5 (6.0) |
| Injection site reactions | 0 | 2 (6.1) | 0 | 9 (10.8) |
| Event, n (%) . | OD group . | RP group . | ||
|---|---|---|---|---|
| OP OD therapy (n = 37) . | ATP Marstacimab prophylaxis (n = 33) . | OP RP therapy (n = 91) . | ATP Marstacimab prophylaxis (n = 83) . | |
| Any event | 9 (24.3) | 12 (36.4) | 20 (22.0) | 62 (74.7) |
| Treatment related | NA | 4 (12.1)∗ | NA | 19 (22.9)† |
| Reported in ≥5% of participants‡ | ||||
| COVID-19 | 0 | 2 (6.1) | 3 (3.3) | 18 (21.7) |
| Headache | 0 | 1 (3.0) | 0 | 6 (7.2) |
| Contusion | 0 | 0 | 0 | 5 (6.0) |
| Dental caries | 2 (5.4) | 0 | 0 | 4 (4.8) |
| Pruritus | 0 | 2 (6.1) | 0 | 2 (2.4) |
| Upper respiratory tract infection | 0 | 2 (6.1) | 1 (1.1) | 1 (1.2) |
| Joint range of motion decreased | 1 (2.7) | 2 (6.1) | 0 | 0 |
| Any serious event | 1 (2.7)§ | 0 | 2 (2.2)| | 7 (8.4)¶ |
| Treatment related | NA | 0 | NA | 1 (1.2)# |
| Event leading to treatment discontinuation | 0 | 0 | 0 | 1 (1.2)∗∗ |
| Embolic and thrombotic events | 0 | 0 | 1 (1.1)†† | 0 |
| Events of special interest‡‡ | 9 (24.3) | 14 (42.4) | 15 (16.5) | 46 (55.4) |
| Reported in ≥5% of participants | ||||
| COVID-19 | 0 | 2 (6.1) | 3 (3.3) | 19 (22.9) |
| Hemorrhages | 1 (2.7)§ | 0 | 5 (5.5) | 13 (15.7) |
| Hepatic disorders | 7 (18.9) | 7 (21.2) | 3 (3.3) | 4 (4.8) |
| Hypersensitivity§§ | 0 | 2 (6.1) | 2 (2.2) | 6 (7.2) |
| Hypertension | 1 (2.7) | 2 (6.1) | 2 (2.2) | 5 (6.0) |
| Injection site reactions | 0 | 2 (6.1) | 0 | 9 (10.8) |
NA, not applicable.
Including pruritus (n = 2), gastrointestinal disorders (n = 1; hemorrhoids and thrombosed hemorrhoids), injection site hematoma (n = 1), injection site pain (n = 1).
Including injection site pruritus (n = 4), injection site erythema (n = 3), and prothrombin fragment 1.2 increased (n = 3).
Shown are the number and percent of participants with ≥1 treatment-emergent adverse event. Participants are only counted once per treatment group per preferred term.
Gastric hemorrhage.
Esophagitis and device occlusion.
One occurrence each of: tympanic membrane perforation, chest pain, peripheral swelling, tonsillitis, traumatic hemorrhage, hemarthrosis, meningioma, and hemorrhage.
Grade 1 peripheral calf swelling considered to be treatment related that was diagnostically confirmed to be unrelated to a bleeding or thrombotic event.
Participant with meningioma requiring surgical resection and follow-up therapy permanently discontinued from the study because there was potential elevated risk for development of thrombosis in the postoperative recovery phase and the planned follow-up radiotherapy treatment.
Device occlusion of a blocked port-a-cath over the right subclavicular region without surrounding swelling and tenderness. In 1 attempt, blood was drawn easily and flushed with normal saline without resistance.
Adverse events of special interest are listed by event type by standardized Medical Dictionary for Regulatory Activities query (version 25.1) coding dictionary was applied.
Systemic and localized allergic reactions: conjunctivitis, eczema, pruritus, rash, and rhinitis allergic.