NCT00424047 · OUTCOME
Number of Participants With Adverse Events (AE)
A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2017-10-19
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
- From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months
What was measured
An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
Analysis population: The safety population includes all participants who received at least one dose of study drug regimen
Groups in this outcome
Lenalidomide Plus Dexamethasone
Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
Placebo Plus Dexamethasone
Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.
After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide Plus Dexamethasone | 176 |
|---|
| Placebo Plus Dexamethasone | 175 |
|---|
Reported measurements
≥ 1 Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 176 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 175 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Serious Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 105 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 79 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 AE leading to study drug discontinuation
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 46 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 AE leading to dose reduction or interruption
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 137 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 100 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Drug-Related Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 160 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 151 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Drug-Related Serious Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 54 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
≥Death within ≤ 30 days of last dose of study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Grade 1 or Higher Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 176 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 175 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Grade 2 or Higher Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 168 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 167 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Grade 3 or Higher Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 146 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 119 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Grade 4 or Higher Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide Plus Dexamethasone | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Dexamethasone | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 176
- group Id
- OG001
- value
- 175
- title
- ≥ 1 Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 79
- title
- ≥ 1 Serious Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 31
- title
- ≥ 1 AE leading to study drug discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 100
- title
- ≥ 1 AE leading to dose reduction or interruption
- categories
- measurements
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 151
- title
- ≥ 1 Drug-Related Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 30
- title
- ≥ 1 Drug-Related Serious Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 20
- title
- ≥Death within ≤ 30 days of last dose of study drug
- categories
- measurements
- group Id
- OG000
- value
- 176
- group Id
- OG001
- value
- 175
- title
- ≥ 1 Grade 1 or Higher Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 168
- group Id
- OG001
- value
- 167
- title
- ≥ 1 Grade 2 or Higher Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 146
- group Id
- OG001
- value
- 119
- title
- ≥ 1 Grade 3 or Higher Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 37
- title
- ≥ 1 Grade 4 or Higher Adverse Event
- denoms
- counts
- group Id
- OG000
- value
- 176
- group Id
- OG001
- value
- 175
- units
- Participants
- description
- An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
- groups
- description
- Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
- id
- OG000
- title
- Lenalidomide Plus Dexamethasone
- description
- Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.
After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.
- id
- OG001
- title
- Placebo Plus Dexamethasone
- param Type
- NUMBER
- population Description
- The safety population includes all participants who received at least one dose of study drug regimen
- reporting Status
- POSTED
- time Frame
- From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months
- title
- Number of Participants With Adverse Events (AE)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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