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. 2023 Jul 3;6(7):e2321568. doi: 10.1001/jamanetworkopen.2023.21568

Table 2. Characteristics of SADRs.

Characteristic Patients, No. (%) (Nā€‰=ā€‰351) Innovative therapy of interest Diagnosis Action taken with the therapy of interest Expectedness Corrective treatment
All grade Grade 2 Grade 3 Grade 4
No. of patients who received at least 1 dose of treatment with an SADR 17 (4.8) 2 (0.5) 14 (3.9) 3 (0.8) NA NA NA NA NA
Gastrointestinal disorders
Abdominal pain 1 (0.2) 0 1 (0.2) 0 Azacitidine; venetoclax Acute myeloid leukemia Temporary stop Expected Yes
Diarrhea 1 (0.2) 0 1 (0.2) 0 Dabrafenib mesylate; trametinib Low grade glioma Delayed Expected Yes
Macroglossia 1 (0.2) 0 1 (0.2) 0 Inotuzumab ozogamicin B-cell lymphoblastic leukemia Definitive stop Unexpected Yes
General disorders and administration site conditions
Vomiting 1 (0.2) 0 1 (0.2) 0 Selumetinib Low grade glioma No action Expected Yes
Fever 2 (0.5) 1 (0.2)a 1 (0.2) 0 Dabrafenib mesylate; trametinibb Optic nerve glioma; Low grade glioma Delayed Expected No
Infections and infestations
Acute pyelonephritis 2 (0.5) 1 (0.2)a 1 (0.2) 0 Dabrafenib mesylate; trametinibc Low grade glioma Delayed Expected Yes
Metabolism and nutrition disorders
Hyponatremia 1 (0.2) 0 1 (0.2) 0 Trametinib Low grade glioma Delayed Expected Yes
Nervous system disorders
Neuralgia 1 (0.2) 0 1 (0.2) 0 Lenvatinib mesilate Brain stem glioma Definitive stop Unexpected Yes
Psychiatric disorders
Delirium 1 (0.2) 0 1 (0.2) 0 Alectinib hydrochloride (associated with antiepileptics) Non-Hodgkin Lymphoma Delayed Unexpected No
Respiratory, thoracic, and mediastinal disorders
Pneumothorax 1 (0.2) 0 1 (0.2) 0 Regorafenib Ewing sarcoma Delayed Unexpected Yes
Skin and subcutaneous tissue disorders
Rash maculo-papular 1 (0.2) 0 1 (0.2) 0 Regorafenib Ependymoma Definitive stop Expected Yes
Dry skin 1 (0.2) 0 1 (0.2) 0 Trametinib; Low grade glioma Dose reduced/temporarily stop Expected Yes
Dehiscenced surgical wounds 4 (1.1) 0 2 (0.5) 2 (0.5) Regorafenibc Osteosarcoma Definitive stop Expected No
Benign, malignant, and unspecified neoplasms (including cysts and polyps)
Treatment related secondary malignancy 1 (0.2) 0 0 1 (0.2) Tazemetostat Atypical teratoid/rhabdoid tumor Definitive stop Unexpected Yes
Alanine aminotransferase increased 1 (0.2) 0 1 (0.2) 0 Crizotinibd Acute myeloid leukemia Definitive stop Expected No
Aspartate aminotransferase increased 1 (0.2) 0 1 (0.2) 0 Crizotinibd Acute myeloid leukemia Definitive stop Expected No
Vascular disorders
Capillary leak syndrome 1 (0.2) 0 0 1 (0.2) Tagraxofusp Other leukemia No action Expected Yes
Metabolism and nutrition disorders
GGT increased 1 (0.2) 0 1 (0.2) 0 Crizotinibd Acute myeloid leukemia Definitive stop Expected Yes
Blood and lymphatic system disorders
Febrile neutropenia 1 (0.2) 0 1 (0.2) 0 Dinutuximab beta (plus topotecan/cyclophosphamide) Neuroblastoma No action Expected Yes

Abbreviations: ADR, adverse drug reactions; GGT, gamma-glutamyltransferase; SADR, serious adverse drug reaction.

a

This ADR led to an hospitalization.