TriangleNCT00103506 · OUTCOME
Number of Participants With Serious Adverse Events (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)
What was measured
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Analysis population: Safety population included all the participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Groups in this outcome
Velcade (Bortezomib) Monotherapy
Velcade (bortezomib) 1.3 milligram/meter per square (mg/m\^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
Doxil/Caelyx Plus Velcade (Bortezomib)
Velcade (bortezomib) 1.3 mg/m\^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m\^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
| Group | Source count |
|---|---|
| Velcade (Bortezomib) Monotherapy | 318 |
| Doxil/Caelyx Plus Velcade (Bortezomib) | 318 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Velcade (Bortezomib) Monotherapy | 105 | Not reported | Not reported | Not reported | Not reported |
| Doxil/Caelyx Plus Velcade (Bortezomib) | 120 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 120
- denoms
- counts
- group Id
- OG000
- value
- 318
- group Id
- OG001
- value
- 318
- units
- Participants
- description
- A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- groups
- description
- Velcade (bortezomib) 1.3 milligram/meter per square (mg/m\^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
- id
- OG000
- title
- Velcade (Bortezomib) Monotherapy
- description
- Velcade (bortezomib) 1.3 mg/m\^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m\^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
- id
- OG001
- title
- Doxil/Caelyx Plus Velcade (Bortezomib)
- param Type
- NUMBER
- population Description
- Safety population included all the participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
- reporting Status
- POSTED
- time Frame
- Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)
- title
- Number of Participants With Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice