Table 4.

The NNH in each adverse event from the six completed phase III ramucirumab clinical trials

	SUMMARY		REGARD		RAINBOW		REVEL		RAISE		REACH		ROSE
Safety	RAM	Control	RAM	Control	RAM	Control	RAM	Control	RAM	Control	RAM	Control	RAM	Control
population	N = 2748	N = 2248	n = 236	n = 115	n = 327	n = 329	n = 627	n = 618	n = 529	n = 528	n = 277	n = 276	n = 752	n = 382
	NNH		NNH		NNH		NNH		NNH		NNH		NNH
	All grade	Grade ≥3	All grade	Grade ≥3	All grade	Grade ≥3	All grade	Grade ≥3	All grade	Grade ≥3	All grade	Grade ≥3	All grade	Grade ≥3
Hypertension	7	16	12	20	5	8	17	29	6	12	8	11	6	20
Proteinuria	16	92	280	236	9	82	39	627	8	35	8	46	27	251
Bleeding	5	−1535	71	128	4	54	7	788	5	133	8	−68	4	−111
GI bleeding	46	2768	372	280	25	47	91	318	18	133	145	−46	44	−153
GI perforation	128	133	−4523	−4523	109	82	158	211	88	88	N/C	N/C	84	94
ATE	−252	−1235	59	79	317	17 931	−197	−296	−105	−263	−138	−276	−408	248
VTE	−77	−148	−32	−33	−67	−111	−31	−86	53	48	140	−138	−56	−55
IRR	52	227	−76	N/C	46	164	−116	666	35	265	15	92	−1217	3420
Wound healing	302	550	N/C	N/C	N/C	N/C	−309	N/C	106	529	−276	N/C	94	188

NNH calculated via the following formula: 1/(ramucirumab rate − control rate). Negative values indicate that the incidence of the given adverse event was higher in the control than in the ramucirumab arm.

ATE, arterial thromboembolic events; GI, gastrointestinal; IRR, infusion-related reactions; N/C, not calculable; NNH, number needed to harm; RAM, ramucirumab; VTE, venous thromboembolic events.