NCT02465528 · OUTCOME
Overall Response Rate (ORR) Per Investigator Assessment
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, every 8 weeks until disease progression or end of treatment, whichever came first assessed up to approximately 84 weeks
What was measured
ORR is defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local assessment according to RECIST 1.1, RANO or Cheson hematological criteria.
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) | 100.0 | Not reported | 2.5 | 100.0 | Not reported |
| Inflammatory Myofibroblastic Tumor (IMT) | 75.0 | Not reported | 19.4 | 99.4 | Not reported |
| Glioblastoma (GBM) | 0.0 | Not reported | 0 | 26.5 | Not reported |
| Any Other ALK-positive Tumor | 0.0 | Not reported | 0.0 | 52.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.5
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG001
- lower Limit
- 19.4
- upper Limit
- 99.4
- value
- 75.0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 26.5
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 52.2
- value
- 0.0
- 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
- ORR is defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local assessment according to RECIST 1.1, RANO or Cheson hematological criteria.
- 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, every 8 weeks until disease progression or end of treatment, whichever came first assessed up to approximately 84 weeks
- title
- Overall Response Rate (ORR) Per Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice
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