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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
|---|---|---|---|---|---|---|---|---|
| IG33_DS_TE_010 | XYZ | TE | SCRN | Screen | Informed Consent | 1 week after start of Element | P7D | |
| IG33_DS_TE_010 | XYZ | TE | DRUG1 | Drug 1 | First dose of Drug 1 | 4 weeks after start of Element | P28D | |
| IG33_DS_TE_010 | XYZ | TE | DRUG2 | Drug 2 | First dose of Drug 2 | 4 weeks after start of Element | P28D | |
| IG33_DS_TE_010 | XYZ | TE | DG1INDG | Drug 1 + Investigation Drug | First dose of Investigational Drug, where Investigational Drug is given with Drug 1. | 1 week after start of Element | P7D | |
| IG33_DS_TE_010 | XYZ | TE | DG2INDG | Drug 2 + Investigation Drug | First dose of Investigational Drug, where Investigational Drug is given with Drug 2. | 1 week after start of Element | P7D | |
| IG33_DS_TE_010 | XYZ | TE | FU | Follow-up | One day after last administration of study drug. |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
|---|---|---|---|---|---|---|---|---|
| IG33_DS_TE_011 | DS10 | TE | SCRN | Screen | Informed Consent | Screening assessments are complete, up to 2 weeks after start of Element | ||
| IG33_DS_TE_011 | DS10 | TE | AB | Trt AB | First dose of treatment Element, where treatment is AB | 4 weeks after start of Element | P4W | |
| IG33_DS_TE_011 | DS10 | TE | ABC | Trt ABC | First dose of treatment Element, where treatment AB +C | 4 weeks after start of Element | P4W | |
| IG33_DS_TE_011 | DS10 | TE | FU | Follow-up | Four weeks after start of last treatment element | Death, withdrawal of consent, or loss to follow-up. |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
|---|---|---|---|---|---|---|---|---|
| IG33_TE_TE_001 | EX1 | TE | SCRN | Screen | Informed consent | 1 week after start of Element | P7D | |
| IG33_TE_TE_001 | EX1 | TE | RI | Run-In | Eligibility confirmed | 2 weeks after start of Element | P14D | |
| IG33_TE_TE_001 | EX1 | TE | P | Placebo | First dose of study drug, where drug is placebo | 2 weeks after start of Element | P14D | |
| IG33_TE_TE_001 | EX1 | TE | A | Drug A | First dose of study drug, where drug is Drug A | 2 weeks after start of Element | P14D | |
| IG33_TE_TE_001 | EX1 | TE | B | Drug B | First dose of study drug, where drug is Drug B | 2 weeks after start of Element | P14D |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
|---|---|---|---|---|---|---|---|---|
| IG33_TE_TE_002 | EX2 | TE | SCRN | Screen | Informed consent | 2 weeks after start of Element | P14D | |
| IG33_TE_TE_002 | EX2 | TE | P | Placebo | First dose of a treatment Epoch, where dose is placebo | 2 weeks after start of Element | P14D | |
| IG33_TE_TE_002 | EX2 | TE | 5 | 5 mg | First dose of a treatment Epoch, where dose is 5 mg drug | 2 weeks after start of Element | P14D | |
| IG33_TE_TE_002 | EX2 | TE | 10 | 10 mg | First dose of a treatment Epoch, where dose is 10 mg drug | 2 weeks after start of Element | P14D | |
| IG33_TE_TE_002 | EX2 | TE | REST | Rest | 48 hrs after last dose of preceding treatment Epoch | 1 week after start of Element | P7D | |
| IG33_TE_TE_002 | EX2 | TE | FU | Follow-up | 48 hrs after last dose of third treatment Epoch | 3 weeks after start of Element | P21D |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
|---|---|---|---|---|---|---|---|---|
| IG33_TE_TE_003 | EX4 | TE | SCRN | Screen | Informed Consent | Screening assessments are complete, up to 2 weeks after start of Element | ||
| IG33_TE_TE_003 | EX4 | TE | A | Trt A | First dose of treatment Element, where drug is Treatment A | 5 days after start of Element | P5D | |
| IG33_TE_TE_003 | EX4 | TE | B | Trt B | First dose of treatment Element, where drug is Treatment B | 5 days after start of Element | P5D | |
| IG33_TE_TE_003 | EX4 | TE | REST | Rest | Last dose of previous treatment cycle + 24 hrs | At least 16 days after start of Element and WBC recovered | ||
| IG33_TE_TE_003 | EX4 | TE | FU | Follow-up | Decision not to treat further | 4 weeks | P28D |