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This is a repeat-dose, single-arm, open-label study that will evaluate the potential impact of subject-reported injection-site reactions (ISRs) on activities of daily living (ADL) in adult subjects with cancer receiving SUSTOL® (granisetron) extended-release injection, for subcutaneous use for prevention of chemotherapy induced nausea and vomiting (CINV) for up to 4 sequential cycles of chemotherapy (Moderately Emetogenic Chemotherapy [MEC] or Anthracycline and Cyclophosphamide [AC] combination regimen).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUSTOL | Drug | SUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi | 29401 | United States | ||
| Gabrail Cancer Center Research |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017829 | Granisetron |
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
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| Canton |
| Ohio |
| 44718 |
| United States |
| D011720 |
| Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |