5. Deaths observed in the FUTURE III trial (quadrivalent vaccine, phase 3, women aged 24‐45 years).

ID	Group	Death causes
1	C	Pulmonary thromboembolism with background of acute lymphoblastic leukaemia
2	V	Breast cancer
3	V	Pulmonary tuberculosis
4	V	Thyrotoxicosis
5	V	Cerebral haemorrhage subsequent to hypertension
6	V	Pericarditis on a background of lupus erythematosus
7	V	Nasopharyngeal cancer with metastases to brain
8	V	Pulmonary embolism after intervention for uterine myoma
RR of deaths in vaccine vs placebo arm (7 over 1,890 vs 1 over 1888): RR = 6.99 (95% CI 0.86 to 56.78), 2‐sided pexact=0.070. The age at death varied between 29 and 45 years, seven of the deaths occurred in the Philippines and one in Columbia. All participants received three doses of HPV vaccine or placebo except one who received only two doses of vaccine. The time interval between last dose and date at death ranged between 6 and 37 months.

Group:V = vaccinated against HPV, C = control group.

Source: end‐of‐study analysis after a median follow‐up of four years (Castellsagué 2011) and personal communication with Alfred Saah (MSD, 6/05/2016).