NCT02465528 · OUTCOME
Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to approximately 16 weeks
What was measured
The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).
Groups in this outcome
Anaplastic Large Cell Lymphoma (ALCL)
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
Inflammatory Myofibroblastic Tumor (IMT)
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
Glioblastoma (GBM)
Patients with GBM with a translocation involving the ALK gene
Any Other ALK-positive Tumor
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
| Group | Source count |
|---|---|
| Anaplastic Large Cell Lymphoma (ALCL) | 1 |
| Inflammatory Myofibroblastic Tumor (IMT) | 4 |
| Glioblastoma (GBM) | 12 |
| Any Other ALK-positive Tumor | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Large Cell Lymphoma (ALCL) | 100.00 | Not reported | 2.5 | 100.0 | Not reported |
| Inflammatory Myofibroblastic Tumor (IMT) | 75.00 | Not reported | 19.4 | 99.4 | Not reported |
| Glioblastoma (GBM) | 0.0 | Not reported | 0.0 | 26.5 | Not reported |
| Any Other ALK-positive Tumor | 40.0 | Not reported | 5.3 | 85.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.5
- upper Limit
- 100.0
- value
- 100.00
- group Id
- OG001
- lower Limit
- 19.4
- upper Limit
- 99.4
- value
- 75.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 26.5
- value
- 0.0
- group Id
- OG003
- lower Limit
- 5.3
- upper Limit
- 85.3
- value
- 40.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
- id
- OG000
- title
- Anaplastic Large Cell Lymphoma (ALCL)
- description
- Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
- id
- OG001
- title
- Inflammatory Myofibroblastic Tumor (IMT)
- description
- Patients with GBM with a translocation involving the ALK gene
- id
- OG002
- title
- Glioblastoma (GBM)
- description
- Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
- id
- OG003
- title
- Any Other ALK-positive Tumor
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Baseline up to approximately 16 weeks
- title
- Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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