TABLE 4.
Number of cases with acute adverse events (according to CTCAE) by cycle and by cohort (DLBCL treated with R‐COMP‐DI and c‐HL treated with MBVD‐DI) in the overall patient population (n = 81)
| Adverse event | Cycle 1, n (cohort) | Cycle 2, n (cohort) | Cycle 3, n (cohort) | Cycle 4, n (cohort) | Cycle 5, n (cohort) | Cycle 6, n (cohort) | Total, n | % |
|---|---|---|---|---|---|---|---|---|
| Blood | ||||||||
| Anaemia | ||||||||
| Anaemia Grade 1–2 | 2 (DLBCL) | 4 (3 DLBCL, 1 c‐HL) | 3 (DLBCL) | 5 (4 DLBCL, 1 c‐HL) | 6 (5 DLBCL, 1 c‐HL) | 20 | 25 | |
| Anaemia Grade 3–4 | 1 (c‐HL) | 1 (DLBCL) | 1 (DLBCL) | 1 (c‐HL) | 4 | 5 | ||
| Neutropenia | ||||||||
| Neutropenia Grade 1–2 | 1 (DLBCL) | 2 (DLBCL) | 4 (3 DLBCL, 1 c‐HL) | 3 (DLBCL) | 5 (4 DLBCL, 1 c‐HL) | 6 (5 DLBCL, 1 c‐HL) | 21 | 26 |
| Neutropenia Grade 3–4 | 1 (DLBCL) | 2 (1 DLBCL, 1 c‐HL) | 1 (DLBCL) | 4 | 5 | |||
| Thrombocytopenia | ||||||||
| Thrombocytopenia Grade 1–2 | 1 (DLBCL) | 1 (DLBCL) | 1 (DLBCL) | 1 (c‐HL) | 4 | 5 | ||
| Infection | ||||||||
| Febrile neutropenia | ||||||||
| Febrile neutropenia Grade 3–4 | 1 (c‐HL) | 1 (DLBCL) | 1 (DLBCL) | 3 | 4 | |||
| Sepsis | ||||||||
| Sepsis Grade 3–4 | 1 (c‐HL) | 1 (DLBCL) | 1 (DLBCL) | 3 | 4 | |||
| Sepsis Grade 5 | 1 (DLBCL) | 1 | 1.3 | |||||
| Pneumonitis | ||||||||
| Pneumonitis Grade 1–2 | 1 (DLBCL) | 1 (c‐HL) | 2 | 2.5 | ||||
| Pneumonitis Grade 3–4 | 1 (DLBCL) | 1 (DLBCL) | 2 | 2.5 | ||||
| Pneumonitis Grade 5 | 1 (DLBCL) | 1 | 1.3 | |||||
| Gastrointestinal | ||||||||
| Constipation | ||||||||
| Constipation Grade 1–2 | 2 (2 DLBCL) | 1 (c‐HL) | 2 (1 DLBCL, 1 c‐HL) | 1 (DLBCL) | 3 (2 DLBCL, 1 c‐HL) | 9 | 11 | |
| Constipation Grade 3–4 | 1 (c‐HL) | 1 | 1.3 | |||||
| Diarrhoea | ||||||||
| Diarrhoea Grade 1–2 | 1 (DLBCL) | 2 (1 c‐HL, 1 DLBCL) | 1 (DLBCL) | 4 | 5 | |||
| Diarrhoea Grade 3–4 | 1 (c‐HL) | 1 (DLBCL) | 2 | 2.5 | ||||
| Cardiac | ||||||||
| LVS dysfunction Grade 3–4 | 1 (DLBCL) a | 1 | 1.3 | |||||
| Heart rhythm disorders Grade 3–4 | 1 (DLBCL) | 1 | 1.3 | |||||
Note: Adverse Event according to CTCAE (Grade 1–2, Grade 3–4, and Grade 5 reported only when occurred) counted only once, at the highest grade, in patients experiencing multiple occurrences.
Abbreviations: c‐HL, classical Hodgkin lymphoma; CTCAE, Common terminology Criteria for Adverse Events, version 5.0 (published 27 November 2017); DI, dose‐intensified; DLBCL, diffuse large B‐cell lymphoma; LVS, left ventricular systolic dysfunction; MBVD; Myocet™, bleomycin, vinblastine and dacarbazine R‐COMP, rituximab, cyclophosphamide, Myocet™, vincristine and prednisone.
This patient already had baseline LV ejection fraction measurements of <50%.