TriangleNCT00718419 · OUTCOME
Time to Progressive Disease
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to measured progressive disease up to 40.51 months
What was measured
Time to progression is defined as the elapsed time from the date of study enrollment to the date of objectively determined progressive disease (PD). European Group for Blood and Bone Marrow Transplant (EBMT) Response Criteria was used for MM. PD: \>25% increase in serum monoclonal paraprotein (SPEP), 24 hour urinary light chain excretion (LCE), plasma cells in bone marrow (PCBM), soft tissue plasmacytomas (STPC) size increase, new bone lesion or STPC. International Workshop on WM (IWWM) Response Criteria was used for WM. PD: \>25% immunoglobulin M (IgM) increase, progression of clinical findings or symptoms. For participants who had no PD, time to PD was censored at their last contact.
Analysis population: All participants who had at least one dose of the study drug. The numbers of participants censored are 7 (MM) and 33 (WM).
Groups in this outcome
Multiple Myeloma (MM)
Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
Waldenstrom's Macroglobulinemia (WM)
Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
| Group | Source count |
|---|---|
| Multiple Myeloma (MM) | 14 |
| Waldenstrom's Macroglobulinemia (WM) | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Multiple Myeloma (MM) | 5.11 | Not reported | 2.86 | NA | The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment. |
| Waldenstrom's Macroglobulinemia (WM) | 27.73 | Not reported | 20.47 | NA | The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
- group Id
- OG000
- lower Limit
- 2.86
- upper Limit
- NA
- value
- 5.11
- comment
- The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
- group Id
- OG001
- lower Limit
- 20.47
- upper Limit
- NA
- value
- 27.73
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- Time to progression is defined as the elapsed time from the date of study enrollment to the date of objectively determined progressive disease (PD). European Group for Blood and Bone Marrow Transplant (EBMT) Response Criteria was used for MM. PD: \>25% increase in serum monoclonal paraprotein (SPEP), 24 hour urinary light chain excretion (LCE), plasma cells in bone marrow (PCBM), soft tissue plasmacytomas (STPC) size increase, new bone lesion or STPC. International Workshop on WM (IWWM) Response Criteria was used for WM. PD: \>25% immunoglobulin M (IgM) increase, progression of clinical findings or symptoms. For participants who had no PD, time to PD was censored at their last contact.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
- id
- OG000
- title
- Multiple Myeloma (MM)
- description
- Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
- id
- OG001
- title
- Waldenstrom's Macroglobulinemia (WM)
- param Type
- MEDIAN
- population Description
- All participants who had at least one dose of the study drug. The numbers of participants censored are 7 (MM) and 33 (WM).
- reporting Status
- POSTED
- time Frame
- Baseline to measured progressive disease up to 40.51 months
- title
- Time to Progressive Disease
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice