Summary of AEs (safety population)
| . | Mavorixafor (n = 14) . | Placebo (n = 17) . | ||
|---|---|---|---|---|
| Participants with any TEAE, no. (%) | 14 (100) | 17 (100) | ||
| Participants with treatment-related TEAEs, no. (%) | 7 (50) | 3 (17.6) | ||
| Participants with any TESAE∗,†,‡, no. (%) | 5 (35.7) | 2 (11.8) | ||
| Participants with treatment-related TESAE, no. (%) | 0 | 0 | ||
| TESAEs†,‡ , no. (%) | ||||
| COVID-19 | 1 (7.1) | 0 | ||
| Campylobacter gastroenteritis | 1 (7.1) | 0 | ||
| Cellulitis | 0 | 1 (5.9) | ||
| Endocarditis | 1 (7.1) | 0 | ||
| Sepsis | 1 (7.1) | 0 | ||
| Thrombocytopenia | 2 (14.3) | 0 | ||
| Febrile neutropenia | 1 (7.1) | 0 | ||
| Lipase increased | 1 (7.1) | 0 | ||
| Platelet count decreased | 1 (7.1) | 0 | ||
| Malignant glioma | 1 (7.1) | 0 | ||
| Pneumonitis | 0 | 1 (5.9) | ||
| TEAE or treatment-related TEAE leading to discontinuation, no. (%) | 0 | 0 | ||
| TEAE or treatment-related TEAE leading to death, no. (%) | 0 | 0 | ||
| Treatment-limiting toxicity, no. (%) | 0 | 0 | ||
| TEAEs reported in ≥2 participants in either group,∗,† no. (%) | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| COVID-19 | 4 (28.6) | — | 5 (29.4) | — |
| Upper respiratory tract infection | 3 (21.4) | 1 (7.1) | 6 (35.3) | 0 |
| Thrombocytopenia | 3 (21.4) | 1 (7.1) | 0 | 0 |
| Dizziness | 2 (14.3) | — | 1 (5.9) | — |
| Epistaxis | 2 (14.3) | — | 1 (5.9) | — |
| Pityriasis | 2 (14.3) | — | 0 | — |
| Rhinitis | 2 (14.3) | — | 0 | — |
| Rash | 2 (14.3) | — | 0 | — |
| Vomiting | 2 (14.3) | — | 0 | — |
| Bronchitis | 1 (7.1) | — | 4 (23.5) | — |
| Cellulitis | 1 (7.1) | 0 | 3 (17.6) | 2 (11.8) |
| Headache | 1 (7.1) | — | 2 (11.8) | — |
| Nasopharyngitis | 1 (7.1) | 0 | 7 (41.2) | 1 (5.9) |
| Urinary tract infection | 1 (7.1) | — | 2 (11.8) | — |
| Conjunctivitis | 0 | — | 3 (17.6) | — |
| Acarodermatitis | 0 | — | 2 (11.8) | — |
| Ear infection | 0 | 0 | 2 (11.8) | 1 (5.9) |
| Ear pain | 0 | — | 2 (11.8) | — |
| Lower respiratory tract infection | 0 | 0 | 3 (17.6) | 1 (5.9) |
| Sinusitis | 0 | 0 | 2 (11.8) | 1 (5.9) |
| Skin infection | 0 | 0 | 2 (11.8) | 1 (5.9) |
| Skin laceration | 0 | — | 2 (11.8) | — |
| Tinea versicolor | 0 | — | 2 (11.8) | — |
| Treatment-related TEAEs,∗,† no. (%) | ||||
| Acute kidney injury | 1 (7.1) | — | 0 | — |
| Dermatitis psoriasiform | 1 (7.1) | — | 0 | — |
| Dizziness | 1 (7.1) | — | 0 | — |
| Dry eye | 1 (7.1) | — | 0 | — |
| Dry skin | 1 (7.1) | — | 0 | — |
| Dysgeusia | 1 (7.1) | — | 0 | — |
| Dyspepsia | 1 (7.1) | — | 0 | — |
| Nausea | 1 (7.1) | — | 0 | — |
| Product aftertaste | 1 (7.1) | — | 0 | — |
| Pruritus | 1 (7.1) | — | 0 | — |
| Rash | 1 (7.1) | — | 0 | — |
| Syncope | 1 (7.1) | 1 (7.1) | 0 | 0 |
| Vomiting | 1 (7.1) | — | 0 | — |
| Cellulitis | 0 | — | 1 (5.9) | — |
| Conjunctivitis | 0 | — | 1 (5.9) | — |
| Headache | 0 | — | 1 (5.9) | — |
| Localized infection | 0 | — | 1 (5.9) | — |
| Lower respiratory tract infection | 0 | — | 1 (5.9) | — |
| Skin infection | 0 | — | 1 (5.9) | — |
| Subcutaneous abscess | 0 | — | 1 (5.9) | — |
| Tonsillitis | 0 | — | 1 (5.9) | — |
| Upper respiratory tract infection | 0 | — | 1 (5.9) | — |
| . | Mavorixafor (n = 14) . | Placebo (n = 17) . | ||
|---|---|---|---|---|
| Participants with any TEAE, no. (%) | 14 (100) | 17 (100) | ||
| Participants with treatment-related TEAEs, no. (%) | 7 (50) | 3 (17.6) | ||
| Participants with any TESAE∗,†,‡, no. (%) | 5 (35.7) | 2 (11.8) | ||
| Participants with treatment-related TESAE, no. (%) | 0 | 0 | ||
| TESAEs†,‡ , no. (%) | ||||
| COVID-19 | 1 (7.1) | 0 | ||
| Campylobacter gastroenteritis | 1 (7.1) | 0 | ||
| Cellulitis | 0 | 1 (5.9) | ||
| Endocarditis | 1 (7.1) | 0 | ||
| Sepsis | 1 (7.1) | 0 | ||
| Thrombocytopenia | 2 (14.3) | 0 | ||
| Febrile neutropenia | 1 (7.1) | 0 | ||
| Lipase increased | 1 (7.1) | 0 | ||
| Platelet count decreased | 1 (7.1) | 0 | ||
| Malignant glioma | 1 (7.1) | 0 | ||
| Pneumonitis | 0 | 1 (5.9) | ||
| TEAE or treatment-related TEAE leading to discontinuation, no. (%) | 0 | 0 | ||
| TEAE or treatment-related TEAE leading to death, no. (%) | 0 | 0 | ||
| Treatment-limiting toxicity, no. (%) | 0 | 0 | ||
| TEAEs reported in ≥2 participants in either group,∗,† no. (%) | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| COVID-19 | 4 (28.6) | — | 5 (29.4) | — |
| Upper respiratory tract infection | 3 (21.4) | 1 (7.1) | 6 (35.3) | 0 |
| Thrombocytopenia | 3 (21.4) | 1 (7.1) | 0 | 0 |
| Dizziness | 2 (14.3) | — | 1 (5.9) | — |
| Epistaxis | 2 (14.3) | — | 1 (5.9) | — |
| Pityriasis | 2 (14.3) | — | 0 | — |
| Rhinitis | 2 (14.3) | — | 0 | — |
| Rash | 2 (14.3) | — | 0 | — |
| Vomiting | 2 (14.3) | — | 0 | — |
| Bronchitis | 1 (7.1) | — | 4 (23.5) | — |
| Cellulitis | 1 (7.1) | 0 | 3 (17.6) | 2 (11.8) |
| Headache | 1 (7.1) | — | 2 (11.8) | — |
| Nasopharyngitis | 1 (7.1) | 0 | 7 (41.2) | 1 (5.9) |
| Urinary tract infection | 1 (7.1) | — | 2 (11.8) | — |
| Conjunctivitis | 0 | — | 3 (17.6) | — |
| Acarodermatitis | 0 | — | 2 (11.8) | — |
| Ear infection | 0 | 0 | 2 (11.8) | 1 (5.9) |
| Ear pain | 0 | — | 2 (11.8) | — |
| Lower respiratory tract infection | 0 | 0 | 3 (17.6) | 1 (5.9) |
| Sinusitis | 0 | 0 | 2 (11.8) | 1 (5.9) |
| Skin infection | 0 | 0 | 2 (11.8) | 1 (5.9) |
| Skin laceration | 0 | — | 2 (11.8) | — |
| Tinea versicolor | 0 | — | 2 (11.8) | — |
| Treatment-related TEAEs,∗,† no. (%) | ||||
| Acute kidney injury | 1 (7.1) | — | 0 | — |
| Dermatitis psoriasiform | 1 (7.1) | — | 0 | — |
| Dizziness | 1 (7.1) | — | 0 | — |
| Dry eye | 1 (7.1) | — | 0 | — |
| Dry skin | 1 (7.1) | — | 0 | — |
| Dysgeusia | 1 (7.1) | — | 0 | — |
| Dyspepsia | 1 (7.1) | — | 0 | — |
| Nausea | 1 (7.1) | — | 0 | — |
| Product aftertaste | 1 (7.1) | — | 0 | — |
| Pruritus | 1 (7.1) | — | 0 | — |
| Rash | 1 (7.1) | — | 0 | — |
| Syncope | 1 (7.1) | 1 (7.1) | 0 | 0 |
| Vomiting | 1 (7.1) | — | 0 | — |
| Cellulitis | 0 | — | 1 (5.9) | — |
| Conjunctivitis | 0 | — | 1 (5.9) | — |
| Headache | 0 | — | 1 (5.9) | — |
| Localized infection | 0 | — | 1 (5.9) | — |
| Lower respiratory tract infection | 0 | — | 1 (5.9) | — |
| Skin infection | 0 | — | 1 (5.9) | — |
| Subcutaneous abscess | 0 | — | 1 (5.9) | — |
| Tonsillitis | 0 | — | 1 (5.9) | — |
| Upper respiratory tract infection | 0 | — | 1 (5.9) | — |
AE, adverse event; COVID-19, coronavirus disease 2019; TESAE, treatment-emergent serious adverse event.
Participants may have experienced ≥2 different AEs.
Preferred term.
TESAEs were reported in 5 participants receiving mavorixafor: 1 participant (thrombocytopenia, grade 2; febrile neutropenia, grade 3); 1 participant (Campylobacter gastroenteritis, grade 2; thrombocytopenia, grade 4; sepsis, grade 4; endocarditis, grade 3); 1 participant (platelet count decrease, grade 3); 1 participant (lipase increased, grade 4; COVID-19, grade 1); and 1 participant (malignant glioma, grade 4). TESAEs were reported in 2 participants receiving placebo: 1 participant (cellulitis, grade 3) and 1 participant (pneumonitis, grade 4).