Table 4.
Incidence of Treatment‐Emergent Serious Adverse Events
| Serious Adverse Event | InO (n = 164), No. (%) | SoC (n = 143), No. (%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Any Grade | Grade ≥ 3 | Grade 3 | Grade 4 | Grade 5 | Any Grade | Grade ≥3 | Grade 3 | Grade 4 | Grade 5 | |
| Any | 85 (51.8) | 80 (48.8) | 37 (22.6) | 17 (10.4) | 26 (15.9) | 72 (50.3) | 71 (49.7) | 34 (23.8) | 21 (14.7) | 16 (11.2) |
| Febrile neutropenia | 19 (11.6) | 19 (11.6) | 16 (9.8) | 3 (1.8) | 0 (0) | 27 (18.9) | 27 (18.9) | 20 (14.0) | 7 (4.9) | 0 (0) |
| Veno‐occlusive liver disease | 23 (14.0) | 19 (11.6) | 8 (4.9) | 6 (3.7) | 5 (3.0) | 3 (2.1)a | 3 (2.1) | 3 (2.1) | 0 (0) | 0 (0) |
| Sepsis | 4 (2.4) | 4 (2.4) | 0 (0) | 2 (1.2) | 2 (1.2) | 10 (7.0) | 10 (7.0) | 1 (0.7) | 7 (4.9) | 2 (1.4) |
| Disease progression | 8 (4.9) | 8 (4.9) | 0 (0) | 0 (0) | 8 (4.9) | 5 (3.5) | 5 (3.5) | 0 (0) | 0 (0) | 5 (3.5) |
| Pneumonia | 10 (6.1) | 9 (5.5) | 5 (3.0) | 1 (0.6) | 3 (1.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Respiratory failure | 2 (1.2) | 2 (1.2) | 1 (0.6) | 1 (0.6) | 0 (0) | 6 (4.2) | 6 (4.2) | 0 (0) | 3 (2.1) | 3 (2.1) |
| Pyrexia | 5 (3.0) | 2 (1.2) | 2 (1.2) | 0 (0) | 0 (0) | 3 (2.1) | 1 (0.7) | 0 (0) | 1 (0.7) | 0 (0) |
| Neutropenic sepsis | 3 (1.8) | 3 (1.8) | 1 (0.6) | 1 (0.6) | 1 (0.6) | 4 (2.8) | 4 (2.8) | 1 (0.7) | 3 (2.1) | 0 (0) |
| Septic shock | 3 (1.8) | 3 (1.8) | 1 (0.6) | 1 (0.6) | 1 (0.6) | 3 (2.1) | 3 (2.1) | 1 (0.7) | 1 (0.7) | 1 (0.7) |
| Fungal pneumonia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (2.1) | 3 (2.1) | 3 (2.1) | 0 (0) | 0 (0) |
| Hyperbilirubinemia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (2.1) | 3 (2.1) | 2 (1.4) | 1 (0.7) | 0 (0) |
| Subdural hematoma | 1 (0.6) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (2.1) | 3 (2.1) | 2 (1.4) | 1 (0.7) | 0 (0) |
| Hypotension | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (2.1) | 2 (1.4) | 0 (0) | 2 (1.4) | 0 (0) |
Abbreviations: InO, inotuzumab ozogamicin; SoC, standard of care (intensive chemotherapy).
The data represent the safety population from the January 4, 2017, data cutoff. Serious adverse events with an incidence ≥2% in either of the treatment arms are shown. Adverse events were graded according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 3.0).
A clinical site visit conducted in July 2017 (after the clinical database had been locked) confirmed that a fourth case of veno‐occlusive liver disease/sinusoidal obstruction syndrome had occurred in a patient in the SoC arm. This case occurred in March 2013 (~3 months after the patient received the last dose of the study drug treatment), was not entered onto the case report form, and, therefore, is not included.