|
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. |
