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This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G17DT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G17DT | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic | Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies. | Up to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | The vital status was monitored throughout the study and was followed up to the death of the last patient. | Up to week 139 |
| Number of Participants with Serious and Non-Serious Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l
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Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.
| Up to week 60 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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