Table 4 Description of ADRs in labeling

Temsirolimus

ILD: JP. 11/20(55%), nJP. 52/178 (29.2%)

ND

Eribulin mesilate

Neutropenia: JP. 80/81 (98.8%), nJP. 481/827 (58.2%)

a)

Crizotinib

Neutropenia: JP. 3/15 (20%), nJP. 3/104 (2.9%)

a)

Regorafenib

ALT increased: JP. 13/65 (20%), nJP. 15/433 (3.4%)

ND

Pertuzumab

ILD: JP. 2/26 (7.7%), nJP. 7/381 (1.8%)

b)

Afatinib maleate

ILD: JP. 4/54 (7.4%), nJP. 3/175 (1.7%)

a)

Abiraterone acetate

Hepatotoxicity: JP. 20/48 (41.7%), nJP. 90/543 (16.6%)

a)

Cabazitaxel acetate

Myelosuppression: JP. 44/44 (100%), nJP. 130/371 (35%)

AST increased: JP. 6/47 (12.5%), nJP. 4 (1.1%)

ND

Nivolumab

AST increased: JP. 14/52 (26.9%), nJP. 28/345 (8.1%)

a)

Vemurafenib

Hepatic impairment: JP. 5/11 (45.5%), nJP. 91/337 (27.5%)

ND

Ramucirumab

Neutropenia: JP. 58/68 (85.3%), nJP. 120/259 (27.5%)

b)

Ipilimumab

AST increased: JP. 4/20 (20%), nJP. 1/131 (0.8%)

ND

Vandetanib

ILD: JP. 1/14 (7.1%), nJP. 2/231 (0.9%)

Renal impairment: JP. 5/14 (35.7%), nJP. 49/231(21.2%)

Hepatic impairment: JP. 3/14 (21.4%), nJP. 29/231 (8.2%)

b) (Hepatic impairment)

Trabectedin

Neutropenia: JP. 64/73 (87.7%), nJP. (75/130 (57.7%)

ALT increased: JP. 52/73 (71.2%), NJP. 72/130 (55.4%)

a)

Dabrafenib mesilate

Hepatic impairment: JP. 6/12 (50%), nJP. 39/398 (9.8)

Myelosuppression: JP. 8 (66.7%), nJP. 48/398 (12.1%)

b) for hepatic impairment

Osimertinib mesilate

White blood cell count decreased: JP. 21/80 (26.3%), nJP. 10/331 (3%)

ND

Ceritinib

Blood ALP increased: JP. 11/19 (57.9%), nJP. 14/105 (13.3%)

Blood creatinine increased: JP. 9/19 (47.4%), nJP. 17/105 (16.2%)

White blood cell count decreased: JP. 4/19 (21.1%), nJP. 2/105 (1.9%)

ND

Afliberceot Beta

Neutropenia: JP. 46/62 (74.2%), nJP. 238/611 (39.0%)

a)

Palbociclib

White blood cell count decreased: JP. 17/27 (63.0%), nJP. 88/318 (27.7%)

ALT increased: JP. 7/32 (21.9%), nJP. 37/412 (9.0%)

ND

Avelumab

Anemia: JP. 8/43 (18.6%), nJP. 105/1764 (6.0%)

ND

Olaparib

White blood cell count decreased: JP. 5/8 (62.5%), nJP. 6/187 (3.2%)

b)

Durvalumab

ILD: JP. 53/72 (73.6%), nJP. 108/403 (26.8%)

ND

Abemaciclib

Neutrophil count decreased: JP. 34/43 (79.1%), nJP. 103/277 (37.2%)

ALT increased: JP. 15/43 (34.9%), nJP 24/277 (8.7%)

Blood creatinine increased: JP. 13/43 (30.2%), nJP. 24/277 (8.7%)

ND

Ebcorfenib/ Binimetinib

Anemia: JP. 3/10 (30%), nJP. 50/439 (11.4%)

ND

Necitumumab

Neutrophil count decreased: JP. 53/90 (58.9%), nJP. 8/538 (1.5%)

ALT increased: JP. 17/90 (18.9%), NJP 27/538 (5.0%)

ND

Entrectinib

Blood creatinine increased: JP. 11/16 (68.8%), nJP. 48/190 (25.3%)

AST increased: JP. 9/16 (56.3%), nJP. 32/190 (16.8%)

White blood cell count decreased: JP. 4/16 (25.0%), nJP. 9/190 (4.7%)

ND

Cabozantinib malate

Renal impairment: JP. 15/35 (42.9%), nJP. 70/331 (21.1%)

Hepatic impairment: JP. 25/35 (71.4%), nJP. 93/331 (28.1%)

b) for hepatic impairment

Tepotinib hydrochloride

hydrate

Blood creatinine increased: JP. 9/17 (52.9%), nJP. 22/113 (19.5%)

b)

Irinotecan hydrochloride hydrate (liposome injection)

Hepatic impairment: JP. 19/46 (41.3%), nJP. 20/117 (17.1%)

Myelosuppression: JP. 38/46 (82.6%), nJP. 76/117 (65.0%)

b) for hepatic impairment

Trastuzumab deruxtecan

Neutrophil count decreased: JP. 22/30 (73.3%), nJP. 35/154 (22.7%)

ILD: JP. 51/316 (16.1%), nJP. 21/329 (6.4%)

AST increased: JP. 7/21 (33.3%), nJP. 2/29 (6.9%)

ND

Capmatinib hydrochcrolide hydrate

Blood creatinine increased: JP. 25/45 (55.6%), nJP. 60/289 (20.8%)

ALT increased: JP. 10/45 (22.2%), nJP. 32/289 (11.1%)

Platelet count decreased: 8/45 (17.8%), nJP. 6/289 (2.1%)

b) for renal impairment

Niraparib tosilate hydrate

Platelet count decreased: JP. 12/19 (63.2%), nJP. 77/367 (21.0%)

ND