Table 2:
Safety Outcomes
| Outcomes | Solithromycin (n=70) |
Comparator (n=24) |
||
|---|---|---|---|---|
| n/N (%) | 95% CI | n/N (%) | 95% CI | |
| Related AEs causing drug discontinuation, n (%) | 3/70 (4.3) | (1%, 12%) | 0/24 (0)1 | (0%, 14%) |
| Reason for discontinuation, n (%) | ||||
| Infusion site reaction2 | 2 (2.9) | 0 | ||
| Urticaria | 1 (1.4) | 0 | ||
| Other | 0 | 0 | ||
| Treatment emergent AE, n (%) | 24/70 (34.3) | (23%, 47%) | 7/24 (29.2) | (13%, 51%) |
| Treatment emergent AE by system, n (%)3 | ||||
| Anaemia | 1/70 (1.4) | 0 | ||
| Bradycardia | 0 | 1/24 (4.2) | ||
| Diarrhoea | 1/70 (1.4) | 4/24 (16.7) | ||
| Abdominal discomfort | 1/70 (1.4) | 0 | ||
| Vomiting | 1/70 (1.4) | 0 | ||
| Fatigue | 0 | 1/24 (4.2) | ||
| Infusion site findings | ||||
| Pain | 6/70 (8.6) | 0 | ||
| Pruritis | 1/70 (1.4) | 0 | ||
| Urticaria | 1/70 (1.4) | 0 | ||
| Reaction | 1/70 (1.4) | 0 | ||
| Peripheral oedema | 1/70 (1.4) | 0 | ||
| Infection-related findings | ||||
| Bacteraemia | 1/70 (1.4) | 0 | ||
| Infectious pleural effusion | 1/70 (1.4) | 0 | ||
| Hypokalaemia | 0 | 1/24 (4.2) | ||
| Hyperglycaemia | 1/70 (1.4) | 0 | ||
| Respiratory | ||||
| Nasal congestion | 0 | 1/24 (4.2) | ||
| Epistaxis | 1/70 (1.4) | 0 | ||
| Allergic rhinitis | 1/70 (1.4) | 0 | ||
| Tachypnoea | 1/70 (1.4) | 0 | ||
| Skin/Subcutaneous | ||||
| Pruritis | 1/70 (1.4) | 0 | ||
| Rash (not defined) | 1/70 (1.4) | 0 | ||
| Rash erythematous | 1/70 (1.4) | 0 | ||
| Rash maculopapular | 1/70 (1.4) | 0 | ||
| Urticaria | 1/70 (1.4) | 0 | ||
| Phlebitis | 5/70 (7.1) | 0 | ||
| SAE, n (%)4 | 1/70 (1.4) | 1/24 (4.2) | ||
| Viral pneumonia | 0 | 1 (4.2) | ||
| Pneumonia | 1 (1.4) | 0 | ||
| Related AE, n (%) | 17/70 (24.3) | 2/24 (8.3) | ||
| Diarrhea | 0 | 2 (8.3) | ||
| Epistaxis | 1 (1.4) | 0 | ||
| Hepatic enzyme increase | 5 (7.1) | 0 | ||
| Infusion site reaction | 11 (15.7) | 0 | ||
| Abdominal discomfort | 1 (1.4) | 0 | ||
| Fatal SAE, n (%) | 0 | 0 | ||
AE – adverse event, SAE – serious adverse event, CI – confidence interval
1 –
one participant in the comparator group had TEAE (viral pneumonia) which led to drug discontinuation but this was deemed not related to study drug
2 –
one participant reported pain/phlebitis, one reported pain, pruritis/urticaria
3 -
infusion site AEs
4 –
both SAEs were deemed not related to study drug