Table 2.

Patients with DLBCL (phase Ia extension) and solid tumors (phase Ib expansion) experiencing grade ≥3 DLTs during the MTD evaluation and study treatment periods, respectively

DLBCLa	Dose	Patient reference number	DLT	Duration	Grade	Action	Therapy	Outcome	Serious
Phase Ia extension (DLBCL): total patients with DLTs on BI 894999 (schedule B; 1.5 mg, n = 1; 2.0 mg, n = 1; 2.5 mg, n = 2)
	1.5 mg	#605	Increased troponin	5 days	3	None	No	Recovered	No
	2.0 mg	#130	Thrombocytopenia	11 days	4	Discontinued	No	Not recovered	No
	2.5 mg	#233	Thrombocytopenia	5 days	4	Reduced dose	Yes	Not recovered	No
		#402	Sepsis	6 days	4	Reduced dose	Yes	Recovered	Immediately life-threatening; required hospitalization
			Febrile neutropenia	7 days	3	Reduced dose	Yes	Recovered	Required hospitalization
			Thrombocytopenia	2 days	4	Reduced dose	Yes	Not recovered	No

Phase Ib expansion: total patients with DLTs on BI 894999 (schedule B; 2.5 mg), n = 14
Tumor type	Patient reference number	DLT	Duration	Grade	Action	Therapy	Outcome	Serious
SCLC	#303	Laryngeal inflammation	—	3	Discontinued	Yes	Unknown	Required hospitalization
		Thrombocytopenia	—	4	None	Yes	Unknown	Required hospitalization
	#132	Thrombocytopenia	4 days	4	Discontinued	Yes	Not recovered	No
		Decreased appetite	9 days	3	None	No	Recovered	No
		Fatigue	—	3	None	No	Not recovered	No
		Troponin T increased	11 days	3	None	No	Recovered	No
	#505	Thrombocytopenia	6 days	4	None	Yes	Not recovered	Required hospitalization
CRC	#129	Dermatitis acneiform	—	3	None	Yes	Unknown	Required hospitalization
	#417	Thrombocytopenia	—	4	None	No	Not recovered	No
mCRPC	#230	Thrombocytopenia	40 days	4	Reduced dose	Yes	Not recovered	No
	#231	Thrombocytopenia	4 days	4	Reduced dose	No	Not recovered	No
	#308	Decreased platelet count	4 days	4	Reduced dose	Yes	Not recovered	Required hospitalization
	#403	Troponin T increased	—	3	None	No	Unknown	No
	#406	Thrombocytopenia	3 days	4	None	No	Not recovered	No
		Stomatitis	—	3	None	Yes	Not recovered	No
	#408	Nausea	—	3	Discontinued	Yes	Not recovered	Required hospitalization
		Decreased appetite	8 days	3	None	No	Recovered	No
		Hypophosphatemia	12 days	3	Reduced dose	Yes	Recovered	Required hospitalization
	#414	Thrombocytopenia	22 days	4	Discontinued	No	Not recovered	No
NUT carcinoma	#851	Decreased platelet count	—	4	Reduced dose	No	Not recovered	Required hospitalization
	#854	Decreased platelet count	6 days	4	None	No	Not recovered	Other

Phase Ib expansion: total patients with DLTs on BI 894999 (schedule C; 6.0/3.0 mg), n = 3
NUT carcinoma	#1840007004	Pleural effusion	3 days	3	None	Yes	Recovered	Required hospitalization
		Fatigue	16 days	3	None	No	Not recovered	No
	#816	Fatigue	36 days	3	Reduced dose	No	Not recovered	No
		Diarrhea	3 days	3	Reduced dose	Yes	Not recovered	No
	#857	Decreased platelet count	—	4	None	Yes	Not recovered	Required hospitalization/prolonged hospitalization

CRC, colorectal cancer; DLBCL, diffuse large B-cell lymphoma; DLT, dose-limiting toxicity; mCRPC, metastatic castration-resistant prostate cancer; MTD, maximum tolerated dose; NUT, nuclear protein in testis; SCLC, small-cell lung cancer.

^aNo DLBCL patients on schedule C experienced DLTs on BI 894999.