Table 1.
Study visits and reasons for early discontinuation of study medication
| |
Telavancin |
Standard therapy |
Overall |
|---|---|---|---|
| (n = 29) | (n = 29) | (n = 58) | |
| Completed FU visit |
23 (79%) |
26 (90%) |
49 (84%) |
| Completed TOC visit |
14 (48%) |
17 (59%) |
31 (53%) |
| Completed 14 days of therapy |
13 (45%) |
17 (59%) |
30 (52%) |
| Discontinued study drugs early |
16 (55%)
a
|
12 (41%) |
28 (48%) |
| Reason for early study drug discontinuation |
|
|
|
| Continuation criteria not met
b
|
5 (17%) |
2 (7%) |
7 (12%) |
| Adverse event |
2 (7%) |
2 (7%) |
4 (7%) |
| Consent withdrawal |
2 (7%) |
2 (7%) |
4 (7%) |
| 2 Consecutive ECGs with QTc >500 msec |
0 |
1 (3%) |
1 (2%) |
| Major protocol deviation |
1 (3%)
c
|
0 |
1 (2%) |
| Other | 6 (21%) | 5 (17%) d | 11 (19%) |
AE, adverse event; ECG, electrocardiogram; FU, follow-up visit; TOC, test-of-cure visit.
a Includes the only patient who was included under the amendment for complicated bacteremia and who was discontinued due to an AE after receiving 24 days of therapy.
b A patient may have failed more than one continuation criterion; in patients failing continuation criteria the reason for early drug discontinuation decided by the investigators may have been different from not meeting such continuation criteria.
c This patient also failed continuation criteria.
d One patient in this group also failed continuation criteria.