TriangleNCT00135200 · OUTCOME
Percentage of Patients With an Objective Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 3 months
What was measured
The primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level. An objective response may be: Minimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations. Partial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations. Complete Response (CR) - Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation.
Groups in this outcome
Bexxar Therapeutic
The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
| Group | Source count |
|---|---|
| Bexxar Therapeutic | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bexxar Therapeutic | 31 | Not reported | 11 | 59 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11
- upper Limit
- 59
- value
- 31
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- The primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level. An objective response may be: Minimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations. Partial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations. Complete Response (CR) - Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
- id
- OG000
- title
- Bexxar Therapeutic
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 3 months
- title
- Percentage of Patients With an Objective Response
- type
- PRIMARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice