Reactions Duration (median) Reactions at Day 0b Reactions at Days 0-7b Reactions at Days 8-30b
n (%)a (days)
[Analysis Population=553 participants]          
[Total number of ISR=896]
Participants with ISR 420 (75.9) 2 318 (57.5) 420 (75.9) 3 (0.5)
Participants with Serious ISR 1 (0.2) 4 0 (0.0) 1 (0.2) 0 (0.0)
Participants with:          
Solicited ISR after Triaxis® between Day 0 and Day 7 414 (74.9) 2 314 (56.8) 414 (74.9) -
Severe 122 (22.1) 3 32 (5.8) 122 (22.1)[3] -
Serious 0 (0.0) - 0 (0.0) 0 (0.0) -
Visit to hospital or physician 10 (1.8) 5 0 (0.0) 10 (1.8) -
Medication to treat 54 (9.8) 3 41 (7.4) 54 (9.8) -
Unsolicited ISR after Triaxis® between Day 0 and Day 30 79 (14.3) 2 21 (3.8) 76 (13.7) 3 (0.5)
Severe 7 (1.3) 4 4 (0.7) 7 (1.3) 0 (0.0)
Serious 1 (0.2) 4 0 (0.0) 1 (0.2) 0 (0.0)
Visit to hospital or physician 3 (0.5) 3 0 (0.0) 3 (0.5) 0 (0.0)
Medication to treat 4 (0.7) 3 1 (0.2) 4 (0.7) 0 (0.0)
Solicited ISR after Triaxis┬« between Day 0 and Day 7          
Injection-site pain 372 (67.3) 2 303 (54.8) 372 (67.3) 0 (0.0)
Injection-site erythema 215 (38.9) 3 56 (10.1) 215 (38.9) 0 (0.0)
Injection site-swelling 196 (35.4) 3 52 (9.4) 196 (35.4) 0 (0.0)
aAll injection-site reactions are related.
bn (%) is expressed as the number of participants presenting at least once the considered related adverse event/number of analysable participants.
cOne participant had a missing value for the intensity of one solicited ARs between Day 0 and Day 7.
Table 4: Frequency of injection-site reactions.