Table 2.
Incidence rate of any grade 2 or higher clinical and laboratory AEs between tail phase and injection phase
| Tail Phase (n=133*, person-years=148·7) | Injection Phase (n=134*, person-years=85·6) | ||||
|---|---|---|---|---|---|
| Incidence Rate (per 100 PY) | 95% CI | Incidence Rate (per 100 PY) | 95% CI | P-value | |
| Any grade 2 AE† | 214·9 | (180·3, 256·1) | 750·0 | (662·3, 849·2) | <0·0001 |
| Conjunctivitis | 6 | (2·9, 12·8) | 14 | (7·5, 26·3) | 006 |
| Creatinine renal clearance decreased ‡ | 107 | (6·5, 17·6) | 134·5 | (108·1, 167·2) | <0·0001 |
| Genital candidiasis | 3·4 | (1·4, 8·2) | 7·6 | (3·4, 16·6) | 0·14 |
| Headache | 9·8 | (5·4, 17·7) | 28·8 | (18·4, 45·1) | 0·001 |
| Influenza | 5·8 | (2·7, 12·9) | 16·1 | (10·0, 25·8) | 0·02 |
| Injury | 3·8 | (1·7, 8·6) | 3·3 | (1·0, 10·3) | 0·82 |
| Musculoskeletal discomfort | 11·7 | (7·3, 18·9) | 48·3 | (34·8, 67·2) | <0·0001 |
| Nasopharyngitis | 13·8 | (8·6, 22·3) | 23·7 | (14·5, 38·7) | 0·07 |
| Rash | 8·6 | (4·9, 15·0) | 11·3 | (5·4, 23·8) | 0·51 |
| Sinusitis | 4 | (1·8, 8·6) | 10·3 | (4·6, 22·7) | 0·07 |
| Urinary tract infection | 11·1 | (5·1, 24·3) | 14·5 | (7·3, 28·8) | 0·47 |
| Upper respiratory tract infection | 33·4 | (23·5, 47·3) | 40·3 | (26·9, 60·5) | 0·38 |
One participant in the CAB arm of the injection phase did not attend study visits during the tail phase.
Reported events included AE categories reported by 5 or more participants during the tail phase.
Grade 2 AEs for creatinine clearance are determined by a result of <90 to 60 ml/min or a 10% to <30% decrease from baseline. Grade 3 AEs for creatinine clearance are determined by a result of <60 to 30 ml/min or a 30% to <50% decrease from baseline. One participant in the CAB arm of the injection phase did not attend study visits during the tail phase.
Note: Models were adjusted for cohort when incidence rates and their 95% CIs were estimated and the differences between the injection and the tail phase were compared.