Table 2.
Adverse events (AE) by study group.
| Etoricoxib | H56:IC31 | Control | Etoricoxib + H56:IC31 | |
|---|---|---|---|---|
| N = 13 (%) | N = 12 (%) | N = 12 (%) | N = 10 (%) | |
| Day 0 to day 84 | ||||
| Participants with at least one AE | 11 (85%) | 11 (92%) | 11 (92%) | 9 (90%) |
| Number of AEs | 58 | 45 | 54 | 52 |
| Number of SAEs | 2 | 0 | 2 | 1 |
| Number of SUSARs | 1* | |||
| Relationship to study intervention | ||||
| Participants with at least one intervention-related AE | 10 (77%) | 0 | 0 | 9 (90%) |
| Participants with at least one intervention-related SAE | 2 (15%) | 1 (10%) | ||
| Number of AE leading to study drug discontinuation | 2 | 1 | 7 | |
| Most frequent AE (4 or more occurrences) by patient ([no. of events] no. of patients (% of patients)) | ||||
| Fatigue | [9] 8 (62%) | [4] 4 (33%) | [6] 6 (50%) | [3] 3 (30%) |
| Nausea | [7] 6 (46%) | [4] 4 (33%) | [3] 3 (25%) | [6] 5 (50%) |
| Arthralgia | [3] 3 (23%) | [3] 3 (25%) | [6] 6 (50%) | [2] 2 (20%) |
| Headache | [6] 6 (46%) | [5] 5 (42%) | [2] 2 (17%) | [2] 1 (10%) |
| Hepatic enzyme increased | [8] 5 (39%) | [3] 3 (25%) | [3] 2 (17%) | [4] 3 (30%) |
| Myalgia | [3] 3 (23%) | [4] 2 (17%) | [2] 2 (17%) | [2] 2 (20%) |
| Pruritus | [2] 2 (15%) | [1] 1 (8%) | [2] 2 (17%) | [4] 3 (30%) |
| Rash | [1] 1 (8%) | [1] 1 (8%) | [3] 3 (25%) | [1] 1 (10%) |
| Dizziness | [3] 3 (23%) | [1] 1 (8%) | [2] 2 (20%) | |
| Dyspepsia | [1] 1 (8%) | [3] 2 (17%) | [2] 2 (17%) | |
| Decreased appetite | [4] 4 (33%) | [1] 1 (10%) | ||
| Cough | [1] 1 (8%) | [2] 1 (8%) | [2] 2 (20%) | |
| Night sweats | [1] 1 (8%) | [2] 2 (17%) | [1] 1 (10%) | |
| Chest pain | [1] 1 (8%) | [3] 3 (25%) | ||
| Abdominal pain upper | [1] 1 (8%) | [1] 1 (8%) | [2] 2 (17%) | |
| Day 85 to day 154 | N = 11 (%) | N = 11 (%) | N = 10 (%) | N = 8 (%) |
| Participants with at least one AE | 7 (64%) | 9 (82%) | 5 (50%) | 5 (63%) |
| Number of AEs | 20 | 24 | 15 | 15 |
| Number of SAEs | 0 | 0 | 0 | 0 |
| Number of SUSARs | 0 | 0 | 0 | 0 |
| Relationship to study intervention | ||||
| Participants with at least one intervention-related AE | 4 (36%) | 6 (55%) | 3 (38%) | |
| Participants with at least one intervention-related SAE | ||||
| Number of AE leading to study drug discontinuation* | 0 | 1 (9%) | 0 | |
| Most frequent AE (4 or more occurrences) by patient ([no. of events] no. of patients (% of patients)) | ||||
| Arthralgia | [1] 1 (9%) | [4] 4 (36%) | [1] 1 (13%) | |
| Fatigue | [2] 2 (18%) | [3] 3 (27%) | [1] 1 (13%) | |
| Hepatic enzyme increased | [1] 1 (9%) | [2] 2 (18%) | [1] 1 (10%) | |
| Nausea | [1] 1 (9%) | [1] 1 (9%) | [2] 1 (10%) | [1] 1 (13%) |
| Abdominal pain | [1] 1 (9%) | [1] 1 (9%) | [1] 1 (10%) | [1] 1 (13%) |
| Local solicited adverse events | ||||
| Local reaction | [1] 1 (9%) | [1] 1 (13%) | ||
| Vaccination site induration | [1] 1 (13%) | |||
| Vaccination site pain | [1] 1 (9%) | [2] 2 (25%) | ||
| Day 155 to day 238 | N = 10 (%) | N = 11 (%) | N = 9 (%) | N = 8 (%) |
| Participants with at least one AE | 7 (70%) | 8 (73%) | 4 (44%) | 3 (38%) |
| Number of AEs | 12 | 14 | 7 | 8 |
| Number of SAEs | 1 | 0 | 0 | 0 |
| Number of SUSARs | 0 | 0 | 0 | 0 |
| Participants with at least one intervention-related AE | 3 (30%) | 3 (27%) | 2 (25%) | |
| Participants with at least one intervention-related SAE | 1 (10%) | 0 | 0 | 0 |
| Most frequent AE (4 or more occurrences) by patient ([no. of events] no. of patients (% of patients)) | ||||
| None | ||||
AEs across all study groups during three time periods (day 0–84, day 85–154, day 155–238).
*1 patient registered with study drug interruption, but since not receiving second vaccine dose, the AE was re-categorized to “AE leading to study drug discontinuation”.