Table 3.
Serious adverse events and adverse events of special interest in the safety analysis set
| Characteristics | Meplazumab + SoC | Placebo + SoC (N = 41) n (%) | ||
|---|---|---|---|---|
| 0.12 mg/kg (N = 40) n (%) | 0.2 mg/kg (N = 41) n (%) | 0.3 mg/kg (N = 40) n (%) | ||
| TEAEa | 32 (80.0) | 36 (87.8) | 32 (80.0) | 37 (90.2) |
| TEAE by severityb | ||||
| Severe TEAE | 7 (17.5) | 10 (24.4) | 9 (22.5) | 13 (31.7) |
| Moderate TEAE | 6 (15.0) | 13 (31.7) | 5 (12.5) | 6 (14.6) |
| Mild TEAE | 19 (47.5) | 13 (31.7) | 18 (45.0) | 18 (43.9) |
| TEAE by relationship to study drugc | ||||
| Definitely related | 0 | 1 (2.4) | 0 | 0 |
| Probably related | 1 (2.5) | 3 (7.3) | 0 | 0 |
| Possibly related | 2 (5.0) | 8 (19.5) | 4 (10.0) | 4 (9.8) |
| Unlikely related | 5 (12.5) | 2 (4.9) | 4 (10.0) | 2 (4.9) |
| Not related | 24 (60.0) | 22 (53.7) | 24 (60.0) | 31 (75.6) |
| TEAE with an outcome of death | 2 (5.0) | 7 (17.1) | 4 (10.0) | 7 (17.1) |
| TEAE leading to permanent discontinuation of study drug | 2 (5.0) | 7 (17.1) | 4 (10.0) | 7 (17.1) |
| Serious TEAE (TESAE) | 8 (20.0) | 12 (29.3) | 10 (25.0) | 12 (29.3) |
| SAE related to study drug | 1 (2.5) | 0 | 1 (2.5) | 0 |
| TEAE of special interest | 7 (17.5) | 11 (26.8) | 9 (22.5) | 9 (22.0) |
| Disease related secondary infection complications | 4 (10.0) | 8 (19.5) | 5 (12.5) | 8 (19.5) |
| Grade 4 (CTCAE V5) neutropenia and lymphopenia | 1 (2.5) | 2 (4.9) | 0 | 4 (9.8) |
| Anaphylactic reactions defined by clinical criteria | 0 | 0 | 0 | 0 |
| 20% decline in oxygen saturation (SpO2) between start and end of 1-h study drug infusion | 1 (2.5) | 1 (2.4) | 1 (2.5) | 0 |
| ALT or ASTå 3 × ULN and TBLå 2 × ULN | 0 | 0 | 1 (2.5) | 1 (2.4) |
| Evidence of RBC haemolysisd | 1 (2.5) | 1 (2.4) | 2 (5.0) | 0 |
| Infusion related reaction | 1 (2.5) | 0 | 1 (2.5) | 0 |
Note: Percentages are based on the number of patients in the analysis set by treatment group
Note: Patients with multiple events within a category are counted only once for that category
Note: Numbers within TEAE of special interest are not mutually exclusive
aTEAEs are defined as any adverse event that started or worsened in severity on or after the date of randomization
bTEAEs with a missing severity have been classified as severe
cA related TEAE is defined as a TEAE with a relationship of possibly related, probably related or definitely related. TEAEs with a missing relationship have been classified as related
dEvidence of RBC haemolysis is defined by 2 of the following three findings: Anaemia that is not due to another obvious cause; Increased reticulocyte count that is not explained by an obvious cause; and Signs of RBC destruction, such as increased lactate dehydrogenase, low haptoglobin <25 mg/dL, and increased unconjugated bilirubin
Abbreviations: ALT Alanine transaminase, AST Aspartate transaminase, N Number of patients in analysis set, n Number of patients, RBC Red blood cell, SoC Standard of Care, TBL Total bilirubin, TEAE Treatment-Emergent Adverse Event, ULN Upper limit of normal