Relevance of the Weber effect in contemporary pharmacovigilance of oncology drugs

Figures & data

Figure 1 Adverse event reporting trend for all marketed drugs from 2004 to 2012.

Table 1 Oncology new molecular entities approved in 2004–2007 and analyzed as part of the study

Generic name	Date of approval	Review category	Indication
Pemetrexed	February 4, 2004	P, O	• Locally advanced or metastatic nonsquamous non-small cell lung cancer • Mesothelioma
Cetuximab	February 12, 2004	BLA	• Head and neck cancer • Colorectal cancer
Bevacizumab	February 26, 2004	BLA	• Metastatic colorectal cancer • Nonsquamous non-small cell lung cancer • Glioblastoma • Metastatic renal cell carcinoma • Cervical cancer • Platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
Cinacalcet	March 8, 2004	P, O	• Parathyroid carcinoma-associated hypercalcemia
Erlotinib	November 18, 2004	P	• Locally advanced or metastatic non-small cell lung cancer • Locally advanced, unresectable, or metastatic pancreatic cancer
Clofarabine	December 28, 2004	P, O	• Relapsed or refractory acute lymphoblastic leukemia
Nelarabine	October 28, 2005	P, O	• T-cell acute lymphoblastic leukemia • T-cell lymphoblastic lymphoma
Sorafenib	December 20, 2005	P, O	• Unresectable hepatocellular carcinoma • Advanced renal cell carcinoma • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma
Sunitinib	January 26, 2006	P	• Gastrointestinal stromal tumor • Advanced renal cell carcinoma • Pancreatic neuroendocrine tumors
Dasatinib	June 28, 2006	P, O	• Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia • Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia
Panitumumab	September 27, 2006	BLA	• Metastatic colorectal cancer
Lapatinib	March 13, 2007	P	• Advanced or metastatic breast cancer
Temsirolimus	May 30, 2007	P	• Advanced renal cell carcinoma
Ixabepilone	October 16, 2007	P	• Metastatic or locally advanced breast cancer
Nilotinib	October 29, 2007	S, O	• Philadelphia chromosome-positive chronic myeloid leukemia

Abbreviations: BLA, biologics license application; O, orphan drug; P, priority review drug; S, standard review drug.

Table 2 Total AE reports logged in FAERS for studied new molecular entities or biologics

Generic name	Year of approval	Total number of reports (N)	Route of administration
Pemetrexed	2004	1,947	IV
Cetuximab	2004	5,393	IV
Bevacizumab	2004	9,566	IV
Cinacalcet	2004	953	PO
Erlotinib	2004	3,986	PO
Clofarabine	2004	838	IV
Nelarabine	2005	73	IV
Sorafenib	2005	4,793	PO
Sunitinib	2006	7,470	PO
Dasatinib	2006	1,828	PO
Panitumumab	2006	1,767	IV
Lapatinib	2007	5,184	PO
Temsirolimus	2007	2,027	IV
Ixabepilone	2007	1,101	IV
Nilotinib	2007	3,704	PO

Abbreviations: AE, adverse event; FAERS, US Food and Drug Administration Adverse Event Reporting System; IV, intravenous; PO, per oral.

Figure 2 Category A drugs: adverse event reporting pattern.

Figure 3 Category B drugs: adverse event reporting pattern.

Figure 4 Category C drugs: adverse event reporting pattern.

Figure 5 Category D drugs: adverse event reporting pattern.

Figure 6 Category E drugs: adverse event reporting pattern.

Figure 7 Adverse event reporting rate patterns.

Note: Adverse events reported per thousand units sold for seven drugs: pemetrexed, cetuximab, bevacizumab, cinacalcet, erlotinib, dasatinib, and panitumumab.