Table 3.
Most common AEs of any grade (occurring in ≥15% or an AE of special interest [AESI]) or grade 3/4 (occurring in ≥5%, safety population)a.
| Event | Lyophilised belantamab mafodotin 3.4 mg/kg (n = 24) | |
|---|---|---|
| Number of patients (%) | ||
| Any grade | Grade 3/4 | |
| Keratopathy (MECs)b | 23 (96) | 18 (75) |
| Thrombocytopeniac | 11 (46) | 5 (21) |
| Fatigue | 11 (46) | 0 |
| Blurred visiond | 9 (38) | 2 (8) |
| Anaemia | 6 (25) | 4 (17) |
| Dry eyee | 6 (25) | 0 |
| Back pain | 6 (25) | 1 (4) |
| Hyponatraemia | 5 (21) | 1 (4) |
| Intraocular pressure increased | 5 (21) | 0 |
| Headache | 5 (21) | 1 (4) |
| Aspartate aminotransferase increased | 5 (21) | 0 |
| Decreased appetite | 5 (21) | 0 |
| Hypercalcaemia | 4 (17) | 3 (13) |
| Blood lactate dehydrogenase increased | 4 (17) | 0 |
| Pyrexiaf | 4 (17) | 1 (4) |
| Upper respiratory tract infection | 4 (17) | 0 |
| Infusion-related reactionsf | 4 (17) | 0 |
| Hypophosphataemia | 3 (13) | 3 (13) |
| Neutropeniag | 2 (8) | 2 (8) |
AE adverse event, AESI adverse event of special interest, BCVA best-corrected visual acuity, KVA keratopathy and visual acuity, MECs microcyst-like epithelial change.
Listed in order of decreasing frequency of any grade events.
aEvents graded using the Common Terminology Criteria for Adverse Events criteria v4.03, with the exception of keratopathy (MECs)21.
bCorneal epithelium changes (an AESI) were observed on eye examination with or without changes in BCVA from baseline or symptoms. Graded per KVA scale.
cThrombocytopenia (an AESI) includes preferred terms thrombocytopenia, haematoma and platelet count decreased.
dBlurred vision includes preferred terms vision blurred, diplopia and visual acuity reduced.
eDry eye includes preferred terms dry eye and eye pruritus.
fInfusion-related reactions (an AESI) includes preferred terms infusion-related reaction, pyrexia, transfusion reaction and chills occurring ≤24 h of infusion.
gNeutropenia includes neutropenia and neutrophil count decreased.