| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | TATRANS | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_TA_010 | XYZ | TA | DG1INDG | Drug-1+Investigation-Drug | 1 | SCRN | Screen | Randomized to DG1INDG | SCREENING | ||
| IG33_DS_TA_010 | XYZ | TA | DG1INDG | Drug-1+Investigation-Drug | 2 | DRUG1 | Drug-1 | TREATMENT 1 | |||
| IG33_DS_TA_010 | XYZ | TA | DG1INDG | Drug-1+Investigation-Drug | 3 | DG1INDG | Drug 1 + Investigation Drug | TREATMENT 2 | |||
| IG33_DS_TA_010 | XYZ | TA | DG1INDG | Drug-1+Investigation-Drug | 4 | FU | Follow-up | FOLLOW-UP | |||
| IG33_DS_TA_010 | XYZ | TA | DG2INDG | Drug-2+Investigation-Drug | 1 | SCRN | Screen | Randomized to DG2INDG | SCREENING | ||
| IG33_DS_TA_010 | XYZ | TA | DG2INDG | Drug-2+Investigation-Drug | 2 | DRUG2 | Drug-2 | TREATMENT 1 | |||
| IG33_DS_TA_010 | XYZ | TA | DG2INDG | Drug-2+Investigation-Drug | 3 | DG2INDG | Drug 2 + Investigation Drug | TREATMENT 2 | |||
| IG33_DS_TA_010 | XYZ | TA | DG2INDG | Drug-2+Investigation-Drug | 4 | FU | Follow-up | FOLLOW-UP |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | TATRANS | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_TA_011 | DS10 | TA | AB | AB | 0 | SCRN | Screen | Randomized to AB | SCREENING | ||
| IG33_DS_TA_011 | DS10 | TA | AB | AB | 1 | AB | Trt AB | If disease progression, go to follow-up epoch. | TREATMENT | ||
| IG33_DS_TA_011 | DS10 | TA | AB | AB | 2 | AB | Trt AB | If disease progression, go to follow-up epoch. | TREATMENT | ||
| IG33_DS_TA_011 | DS10 | TA | AB | AB | 3 | AB | Trt AB | If disease progression, go to follow-up epoch. | TREATMENT | ||
| IG33_DS_TA_011 | DS10 | TA | AB | AB | 4 | AB | Trt AB | TREATMENT | |||
| IG33_DS_TA_011 | DS10 | TA | AB | AB | 5 | FU | Follow-up | FOLLOW-UP | |||
| IG33_DS_TA_011 | DS10 | TA | ABC | ABC | 0 | SCRN | Screen | Randomized to ABC | SCREENING | ||
| IG33_DS_TA_011 | DS10 | TA | ABC | ABC | 1 | ABC | Trt ABC | If disease progression, go to follow-up epoch. If drug C is dropped, go to element with TAETORD = "5". | TREATMENT | ||
| IG33_DS_TA_011 | DS10 | TA | ABC | ABC | 2 | ABC | Trt ABC | If disease progression, go to follow-up epoch. If drug C is dropped, go to element with TAETORD = "6". | TREATMENT | ||
| IG33_DS_TA_011 | DS10 | TA | ABC | ABC | 3 | ABC | Trt ABC | If disease progression, go to follow-up epoch. If drug C is dropped, go to element with TAETORD = "7". | TREATMENT | ||
| IG33_DS_TA_011 | DS10 | TA | ABC | ABC | 4 | ABC | Trt ABC | Go to follow-up epoch. | TREATMENT | ||
| IG33_DS_TA_011 | DS10 | TA | ABC | ABC | 5 | AB | Trt AB | TREATMENT | |||
| IG33_DS_TA_011 | DS10 | TA | ABC | ABC | 6 | AB | Trt AB | TREATMENT | |||
| IG33_DS_TA_011 | DS10 | TA | ABC | ABC | 7 | AB | Trt AB | TREATMENT | |||
| IG33_DS_TA_011 | DS10 | TA | ABC | ABC | 8 | FU | Follow-up | FOLLOW-UP |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | TATRANS | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_TA_TA_001 | EX1 | TA | P | Placebo | 1 | SCRN | Screen | SCREENING | |||
| IG33_TA_TA_001 | EX1 | TA | P | Placebo | 2 | RI | Run-In | Randomized to Placebo | RUN-IN | ||
| IG33_TA_TA_001 | EX1 | TA | P | Placebo | 3 | P | Placebo | TREATMENT | |||
| IG33_TA_TA_001 | EX1 | TA | A | A | 1 | SCRN | Screen | SCREENING | |||
| IG33_TA_TA_001 | EX1 | TA | A | A | 2 | RI | Run-In | Randomized to Drug A | RUN-IN | ||
| IG33_TA_TA_001 | EX1 | TA | A | A | 3 | A | Drug A | TREATMENT | |||
| IG33_TA_TA_001 | EX1 | TA | B | B | 1 | SCRN | Screen | SCREENING | |||
| IG33_TA_TA_001 | EX1 | TA | B | B | 2 | RI | Run-In | Randomized to Drug B | RUN-IN | ||
| IG33_TA_TA_001 | EX1 | TA | B | B | 3 | B | Drug B | TREATMENT |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | TATRANS | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_TA_TA_002 | EX2 | TA | P-5-10 | Placebo-5mg-10mg | 1 | SCRN | Screen | Randomized to Placebo - 5 mg - 10 mg | SCREENING | ||
| IG33_TA_TA_002 | EX2 | TA | P-5-10 | Placebo-5mg-10mg | 2 | P | Placebo | TREATMENT 1 | |||
| IG33_TA_TA_002 | EX2 | TA | P-5-10 | Placebo-5mg-10mg | 3 | REST | Rest | WASHOUT 1 | |||
| IG33_TA_TA_002 | EX2 | TA | P-5-10 | Placebo-5mg-10mg | 4 | 5 | 5 mg | TREATMENT 2 | |||
| IG33_TA_TA_002 | EX2 | TA | P-5-10 | Placebo-5mg-10mg | 5 | REST | Rest | WASHOUT 2 | |||
| IG33_TA_TA_002 | EX2 | TA | P-5-10 | Placebo-5mg-10mg | 6 | 10 | 10 mg | TREATMENT 3 | |||
| IG33_TA_TA_002 | EX2 | TA | P-5-10 | Placebo-5mg-10mg | 7 | FU | Follow-up | FOLLOW-UP | |||
| IG33_TA_TA_002 | EX2 | TA | 5-P-10 | 5mg-Placebo-10mg | 1 | SCRN | Screen | Randomized to 5 mg - Placebo - 10 mg | SCREENING | ||
| IG33_TA_TA_002 | EX2 | TA | 5-P-10 | 5mg-Placebo-10mg | 2 | 5 | 5 mg | TREATMENT 1 | |||
| IG33_TA_TA_002 | EX2 | TA | 5-P-10 | 5mg-Placebo-10mg | 3 | REST | Rest | WASHOUT 1 | |||
| IG33_TA_TA_002 | EX2 | TA | 5-P-10 | 5mg-Placebo-10mg | 4 | P | Placebo | TREATMENT 2 | |||
| IG33_TA_TA_002 | EX2 | TA | 5-P-10 | 5mg-Placebo-10mg | 5 | REST | Rest | WASHOUT 2 | |||
| IG33_TA_TA_002 | EX2 | TA | 5-P-10 | 5mg-Placebo-10mg | 6 | 10 | 10 mg | TREATMENT 3 | |||
| IG33_TA_TA_002 | EX2 | TA | 5-P-10 | 5mg-Placebo-10mg | 7 | FU | Follow-up | FOLLOW-UP | |||
| IG33_TA_TA_002 | EX2 | TA | 5-10-P | 5mg-10mg-Placebo | 1 | SCRN | Screen | Randomized to 5 mg - 10 mg – Placebo | SCREENING | ||
| IG33_TA_TA_002 | EX2 | TA | 5-10-P | 5mg-10mg-Placebo | 2 | 5 | 5 mg | TREATMENT 1 | |||
| IG33_TA_TA_002 | EX2 | TA | 5-10-P | 5mg-10mg-Placebo | 3 | REST | Rest | WASHOUT 1 | |||
| IG33_TA_TA_002 | EX2 | TA | 5-10-P | 5mg-10mg-Placebo | 4 | 10 | 10 mg | TREATMENT 2 | |||
| IG33_TA_TA_002 | EX2 | TA | 5-10-P | 5mg-10mg-Placebo | 5 | REST | Rest | WASHOUT 2 | |||
| IG33_TA_TA_002 | EX2 | TA | 5-10-P | 5mg-10mg-Placebo | 6 | P | Placebo | TREATMENT 3 | |||
| IG33_TA_TA_002 | EX2 | TA | 5-10-P | 5mg-10mg-Placebo | 7 | FU | Follow-up | FOLLOW-UP |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | TATRANS | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_TA_TA_003 | EX3 | TA | AA | A-Open A | 1 | SCRN | Screen | Randomized to Treatment A | SCREENING | ||
| IG33_TA_TA_003 | EX3 | TA | AA | A-Open A | 2 | DBA | Treatment A | Assigned to Open Drug A on basis of response evaluation | BLINDED TREATMENT | ||
| IG33_TA_TA_003 | EX3 | TA | AA | A-Open A | 3 | OA | Open Drug A | OPEN LABEL TREATMENT | |||
| IG33_TA_TA_003 | EX3 | TA | AR | A-Rescue | 1 | SCRN | Screen | Randomized to Treatment A | SCREENING | ||
| IG33_TA_TA_003 | EX3 | TA | AR | A-Rescue | 2 | DBA | Treatment A | Assigned to Rescue on basis of response evaluation | BLINDED TREATMENT | ||
| IG33_TA_TA_003 | EX3 | TA | AR | A-Rescue | 3 | RSC | Rescue | OPEN LABEL TREATMENT | |||
| IG33_TA_TA_003 | EX3 | TA | BA | B-Open A | 1 | SCRN | Screen | Randomized to Treatment B | SCREENING | ||
| IG33_TA_TA_003 | EX3 | TA | BA | B-Open A | 2 | DBB | Treatment B | Assigned to Open Drug A on basis of response evaluation | BLINDED TREATMENT | ||
| IG33_TA_TA_003 | EX3 | TA | BA | B-Open A | 3 | OA | Open Drug A | OPEN LABEL TREATMENT | |||
| IG33_TA_TA_003 | EX3 | TA | BR | B-Rescue | 1 | SCRN | Screen | Randomized to Treatment B | SCREENING | ||
| IG33_TA_TA_003 | EX3 | TA | BR | B-Rescue | 2 | DBB | Treatment B | Assigned to Rescue on basis of response evaluation | BLINDED TREATMENT | ||
| IG33_TA_TA_003 | EX3 | TA | BR | B-Rescue | 3 | RSC | Rescue | OPEN LABEL TREATMENT |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | TATRANS | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_TA_TA_004 | EX4 | TA | A | A | 1 | SCRN | Screen | Randomized to A | SCREENING | ||
| IG33_TA_TA_004 | EX4 | TA | A | A | 2 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_004 | EX4 | TA | A | A | 3 | REST | Rest | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_004 | EX4 | TA | A | A | 4 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_004 | EX4 | TA | A | A | 5 | REST | Rest | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_004 | EX4 | TA | A | A | 6 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_004 | EX4 | TA | A | A | 7 | REST | Rest | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_004 | EX4 | TA | A | A | 8 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_004 | EX4 | TA | A | A | 9 | REST | Rest | TREATMENT | |||
| IG33_TA_TA_004 | EX4 | TA | A | A | 10 | FU | Follow-up | FOLLOW-UP | |||
| IG33_TA_TA_004 | EX4 | TA | B | B | 1 | SCRN | Screen | Randomized to B | SCREENING | ||
| IG33_TA_TA_004 | EX4 | TA | B | B | 2 | B | Trt B | TREATMENT | |||
| IG33_TA_TA_004 | EX4 | TA | B | B | 3 | REST | Rest | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_004 | EX4 | TA | B | B | 4 | B | Trt B | TREATMENT | |||
| IG33_TA_TA_004 | EX4 | TA | B | B | 5 | REST | Rest | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_004 | EX4 | TA | B | B | 6 | B | Trt B | TREATMENT | |||
| IG33_TA_TA_004 | EX4 | TA | B | B | 7 | REST | Rest | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_004 | EX4 | TA | B | B | 8 | B | Trt B | TREATMENT | |||
| IG33_TA_TA_004 | EX4 | TA | B | B | 9 | REST | Rest | TREATMENT | |||
| IG33_TA_TA_004 | EX4 | TA | B | B | 10 | FU | Follow-up | FOLLOW-UP |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | TATRANS | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_TA_TA_005 | EX5 | TA | A | A | 1 | SCRN | Screen | Randomized to A | SCREENING | ||
| IG33_TA_TA_005 | EX5 | TA | A | A | 2 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_005 | EX5 | TA | A | A | 3 | RESTA | Rest A | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_005 | EX5 | TA | A | A | 4 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_005 | EX5 | TA | A | A | 5 | RESTA | Rest A | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_005 | EX5 | TA | A | A | 6 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_005 | EX5 | TA | A | A | 7 | RESTA | Rest A | TREATMENT | |||
| IG33_TA_TA_005 | EX5 | TA | A | A | 8 | FU | Follow-up | FOLLOW-UP | |||
| IG33_TA_TA_005 | EX5 | TA | B | B | 1 | SCRN | Screen | Randomized to B | SCREENING | ||
| IG33_TA_TA_005 | EX5 | TA | B | B | 2 | B | Trt B | TREATMENT | |||
| IG33_TA_TA_005 | EX5 | TA | B | B | 3 | RESTB | Rest B | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_005 | EX5 | TA | B | B | 4 | B | Trt B | TREATMENT | |||
| IG33_TA_TA_005 | EX5 | TA | B | B | 5 | RESTB | Rest B | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_005 | EX5 | TA | B | B | 6 | B | Trt B | TREATMENT | |||
| IG33_TA_TA_005 | EX5 | TA | B | B | 7 | RESTB | Rest B | TREATMENT | |||
| IG33_TA_TA_005 | EX5 | TA | B | B | 8 | FU | Follow-up | FOLLOW-UP |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | TATRANS | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_TA_TA_006 | EX6 | TA | A | A | 1 | SCRN | Screen | Randomized to A | SCREENING | ||
| IG33_TA_TA_006 | EX6 | TA | A | A | 2 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_006 | EX6 | TA | A | A | 3 | RESTA | Rest A | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_006 | EX6 | TA | A | A | 4 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_006 | EX6 | TA | A | A | 5 | RESTA | Rest A | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_006 | EX6 | TA | A | A | 6 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_006 | EX6 | TA | A | A | 7 | RESTA | Rest A | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_006 | EX6 | TA | A | A | 8 | A | Trt A | TREATMENT | |||
| IG33_TA_TA_006 | EX6 | TA | A | A | 9 | RESTA | Rest A | TREATMENT | |||
| IG33_TA_TA_006 | EX6 | TA | A | A | 10 | FU | Follow-up | FOLLOW-UP | |||
| IG33_TA_TA_006 | EX6 | TA | B | B | 1 | SCRN | Screen | Randomized to B | SCREENING | ||
| IG33_TA_TA_006 | EX6 | TA | B | B | 2 | B | Trt B | TREATMENT | |||
| IG33_TA_TA_006 | EX6 | TA | B | B | 3 | RESTB | Rest B | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_006 | EX6 | TA | B | B | 4 | B | Trt B | TREATMENT | |||
| IG33_TA_TA_006 | EX6 | TA | B | B | 5 | RESTB | Rest B | If disease progression, go to Follow-up Epoch | TREATMENT | ||
| IG33_TA_TA_006 | EX6 | TA | B | B | 6 | B | Trt B | TREATMENT | |||
| IG33_TA_TA_006 | EX6 | TA | B | B | 7 | RESTB | Rest B | TREATMENT | |||
| IG33_TA_TA_006 | EX6 | TA | B | B | 8 | FU | Follow-up | FOLLOW-UP |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | TATRANS | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_TA_TA_007 | EX7 | TA | 1 | CR | 1 | SCRN | Screen | Randomized to CR | SCREENING | ||
| IG33_TA_TA_007 | EX7 | TA | 1 | CR | 2 | ICR | Initial Chemo + RT | INDUCTION TREATMENT | |||
| IG33_TA_TA_007 | EX7 | TA | 1 | CR | 3 | CRNS | Chemo+RT (non-Surgery) | If progression, skip to Follow-up. | INDUCTION TREATMENT | ||
| IG33_TA_TA_007 | EX7 | TA | 1 | CR | 4 | C | Chemo | CONTINUATION TREATMENT | |||
| IG33_TA_TA_007 | EX7 | TA | 1 | CR | 5 | C | Chemo | CONTINUATION TREATMENT | |||
| IG33_TA_TA_007 | EX7 | TA | 1 | CR | 6 | FU | Off Treatment Follow-up | FOLLOW-UP | |||
| IG33_TA_TA_007 | EX7 | TA | 2 | CRS | 1 | SCRN | Screen | Randomized to CRS | SCREENING | ||
| IG33_TA_TA_007 | EX7 | TA | 2 | CRS | 2 | ICR | Initial Chemo + RT | INDUCTION TREATMENT | |||
| IG33_TA_TA_007 | EX7 | TA | 2 | CRS | 3 | CRS | Chemo+RT (Surgery) | If progression, skip to Follow-up. If no progression, but subject is ineligible for or does not consent to surgery, skip to Chemo. |
INDUCTION TREATMENT | ||
| IG33_TA_TA_007 | EX7 | TA | 2 | CRS | 4 | R3 | 3-5 week rest | CONTINUATION TREATMENT | |||
| IG33_TA_TA_007 | EX7 | TA | 2 | CRS | 5 | SURG | Surgery | CONTINUATION TREATMENT | |||
| IG33_TA_TA_007 | EX7 | TA | 2 | CRS | 6 | R4 | 4-6 week rest | CONTINUATION TREATMENT | |||
| IG33_TA_TA_007 | EX7 | TA | 2 | CRS | 7 | C | Chemo | CONTINUATION TREATMENT | |||
| IG33_TA_TA_007 | EX7 | TA | 2 | CRS | 8 | C | Chemo | CONTINUATION TREATMENT | |||
| IG33_TA_TA_007 | EX7 | TA | 2 | CRS | 9 | FU | Off Treatment Follow-up | FOLLOW-UP |