Events Duration (median) Reactions Duration (median) Reactions at Day 0a Reactions at Days 0-7 a n(%) Reactions at Days 8-30 a n(%)
n (%)a (days) n (%)a (days) n(%)
[Analysis Population=553 participants]              
[Total number of Systemic Events = 1102]
Participants with Systemic Events (n (%)) 348(62.9) 2 136 (24.6) 2 86 (15.6) 136 (24.6) 1 (0.2)
Participants with Serious Systemic Events (n (%)) 2 (0.4) 2.5 1 (0.2) 1 1 (0.2) 1 (0.2) 0 (0.0)
Participants with:              
Solicited systemic AE after Triaxis® between Day 0 and Day 7 249 (45.0) 2 129 (23.3) 2 80 (14.5) 129 (23.3) -
Severe 32 (5.8)b 2 10 (1.8)c 2 4 (0.7)d 10 (1.8)c -
Serious 0 (0) - 0 (0) - 0 (0) 0 (0) -
Visit to hospital or physician 22 (4.0) 3 3 (0.5) 1 1 (0.2) 3 (0.5) -
Medication to treat 82 (14.8) 1.5 37 (6.7) 1 17 (3.1) 37 (6.7) -
Unsolicited systemic AE after Triaxis® between Day 0 and Day 30 239 (43.2) 3 17 (3.1) 2 13 (2.4) 16 (2.9) 1 (0.2)
Severe 41 (7.4)e 4 3 (0.5)f 1 3 (0.5) 3 (0.5)g 0 (0.0)
Serious 2 (0.4) 2.5 1 (0.2) 1 1 (0.2) 1 (0.2)h 0 (0.0)
Visit to hospital or physician 122 (22.1) 4 2 (0.4) 4 1 (0.2) 1 (0.2)h 1 (0.2)
Medication to treat 181 (32.7) 3 4 (0.7) 2.5 2 (0.4) 3 (0.5) 1 (0.2)
an (%) is expressed as a percentage of the number of participants presenting at least one relevant adverse event/number of analyzable participants.
bNine participants had missing values for the intensity of one solicited AEs between Day 0 and Day 7.
cOne participant had a missing value for the intensity of solicited systemic ARs between Day 0 and Day 7.
dOne participant had a missing value for the intensity of a solicited AR at Day 0.
eTwo participants had missing values for the intensity of unsolicited systemic AEs at Days 0 to 30.
fOne participant had a missing value for the intensity of an unsolicited systemic AR at Days 0 to 30.
gOne participant had a missing value for the intensity of an unsolicited systemic AR at Days 0 to 7.
hOne participant had missing values to determine seriousness and the need to visit hospital or physician for an unsolicited AR reported between Day 0 and Day 7. The Pharmacovigilance Department confirmed with the investigator that it was not a Serious AR and a visit to the hospital or physician was not made.
Table 3: Frequency of systemic adverse events and reactions.