Supplementary document

Table 1: Cases of EPAR where sex differences in safety results were presented in the two studied time periods (2001-2002 and 2008-2009)
Medicinal product / Difference stated in the report / Explantation given in the report
doripenem (Doribax®) / “Headache was also more common in women than in men but this might be related to the reporting habits rather than to real gender effect of doripenem.” / Notification habits.
sitagliptin/ metformine hydrochloride (Efficib®, Janumet®, Velmetia®) / “women were slightly more sensitive to an effect of sitagliptin on QTc” (prolonged QT interval). / Not discussed
amifampridine (Firdapse®) / “There were 59 reported cases of paraesthesias occurring in 14 men and 45 women.” (the report does not mention the total of participants so that the proportion of AEs by sex can be calculated) / Not discussed
indacaterol (Onbrez Breezhaler®, Oslif Breezhaler®) / “RA: The frequency of Post Inhalation-cough was clearly higher in female patients than in males” / Not discussed
influenza vaccine (IDflu®) / “Overall, there were more vaccinations followed by reactions and events in female than male subjects, and more SAEs were reported in the male population.” / Not discussed
dronedarone (Multaq®) / “females appear to be at higher risk for the development of any TEAE or serious TEAE.” / Greater exposure to drug.
nicotinic acid/ laropiprant (Pelzont®, Tredaptive®, Trevaclyn®) / “A slightly higher percentage of female than male across all treatment groups reported and discontinued due to AEs.” / Not discussed
dabigatran etexilate (Pradaxa®) / “AEs increased with increased age group, increased with decreasing creatinine clearance, and were more frequent in females.” / Lower clearance.
azacitidine (Vidaza®) / “there are 2-fold differences in the frequencies of individual TEAEs between males and females in the azacitidine group” / Not discussed
lacosamide (Vimpat®) / “the incidence of TEAEs was higher in females than in males.” / Not discussed
ertapenem (Invanz®) / “Incidences of all and specific AEs were generally higher in females” / Not discussed
peginterferon alfa-2a (Pegasys®) / AEs reported by sex in a table. These AEs are more frequent in women, in particular: alopecia, oral candidiasis, sinusitis and anemia. / Lower weight.
tacrolimus (Protopic®) / “female patients tended to experience more skin burning, flu syndrome and headache” / Not discussed
arsenic trioxide (Trisenox®) / “sex differences in QTc interval prolongation are observed” / Not discussed
fentanyl (Effentora®) / “women appeared to be at greater risk for application site adverse events.” / Not discussed
febuxostat (Adenuric®) / “the overall incidences of treatment-emergent adverse events were higher for female subjects than for male subjects for each of the treatment groups” / Not discussed
epoetin theta (Biopoin®) / “certain adverse events were more frequent in female patients than in males” / Not discussed
aztreonam (Cayston®) / “the overall incidence of specific AEs was generally higher in females compared with males” / Not discussed
Histamine dihydrochloride (Ceplene®) / “It did not appear to be any consistent relationship between the patient gender and the treatment administered (IL-2 alone, HDC+IL-2, HDC0.5mg+IL-2, HDC1mg+IL-2 or standard care) for almost all of the AE in which there was a difference of at least 5% between male and female patients. However, difference between males and females for headache NOS, nasal congestions, hypotension NOS and injection site erythema appeared to be consistent across the different treatment administered.”. / Not discussed
rivaroxaban (Xarelto®) / “Men had higher bleeding events rates of treatment-emergent major or non-major bleeding events compared to women” / Not discussed
tenecteplase (Metalyse®) / Higher stroke rates in patients with lower weight, these being elders and women. / Lower weight.
algalsidase alfa (Replagal®) / “a higher reported incidence of headache in females compared to males.”
“No infusion reactions were reported in females and there was no evidence of the development an antibody reponse.” / Second finding: “This may reflect that the presence of a small amount of residual enzyme in female patients infers some degree of immunological protection.”