Single Vial Docetaxel Injection - ION Solutions
Single Vial Docetaxel Injection - ION Solutions
Single Vial Docetaxel Injection - ION Solutions
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Adverse Reaction<br />
Fluid Retention<br />
Regardless of<br />
Premedication<br />
Any<br />
Severe<br />
With 3-day<br />
Premedication<br />
Any<br />
Severe<br />
Neurosensory<br />
Any<br />
Severe<br />
Cutaneous<br />
Any<br />
Severe<br />
Nail Changes<br />
Any<br />
Severe<br />
Gastrointestinal<br />
Nausea<br />
Vomiting<br />
Diarrhea<br />
Severe<br />
Stomatitis<br />
Any<br />
Severe<br />
All Tumor Types<br />
Normal LFTs*<br />
n=2045<br />
%<br />
47<br />
7<br />
n=92<br />
64<br />
7<br />
49<br />
4<br />
48<br />
5<br />
31<br />
3<br />
39<br />
22<br />
39<br />
5<br />
All Tumor Types<br />
Elevated LFTs**<br />
n=61<br />
%<br />
39<br />
8<br />
n=3<br />
67<br />
33<br />
34<br />
0<br />
54<br />
10<br />
23<br />
5<br />
38<br />
23<br />
33<br />
5<br />
Breast Cancer<br />
Normal LFTs*<br />
n=965<br />
%<br />
42<br />
6<br />
49<br />
13<br />
52<br />
7<br />
Alopecia 76 62 74<br />
Asthenia<br />
Any<br />
Severe<br />
62<br />
13<br />
53<br />
25<br />
66<br />
15<br />
Myalgia<br />
Any<br />
Severe<br />
19<br />
2<br />
16<br />
2<br />
21<br />
2<br />
Arthralgia 9 7 8<br />
Infusion Site Reactions 4 3 4<br />
*Normal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤2.5 times ULN or<br />
isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN<br />
**Elevated Baseline LFTs: AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase<br />
>2.5 times ULN<br />
***Febrile Neutropenia: ANC grade 4 with fever >38°C with intravenous antibiotics and/or<br />
hospitalization<br />
60<br />
9<br />
n=92<br />
64<br />
7<br />
58<br />
6<br />
47<br />
5<br />
41<br />
4<br />
42<br />
23<br />
43<br />
6<br />
Page 12 of 46
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