Table 2. Characteristics of SADRs.
Characteristic | Patients, No. (%) (Nā=ā351) | 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.
This ADR led to an hospitalization.