TriangleNCT00790842 · OUTCOME
Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient
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
- 56 months
What was measured
The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.
Analysis population: All patients who started treatment
Groups in this outcome
Group A Lenalidomide 10 mg/Day
CrCl 30-60 mL/min, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Group A Lenalidomide 15 mg/Day
CrCl 30-60 mL/min, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Group A Lenalidomide 25 mg/Day
CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Group A Expansion Cohort
CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
Group B Lenalidomide 15 mg/2 Days
CrCl \< 30 mL/min, not on dialysis. Lenalidomide days 15 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Group B Lenalidomide 25 mg/2 Days
CrCl \< 30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Group B Lenalidomide 15 mg/Day
CrCl \< 30 mL/min, not on dialysis. Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Group B Lenalidomide 25 mg/Day
CrCl \< 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Group B Expansion Cohort
CrCl \< 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
Group C Lenalidomide 15 mg 3x/Week
CrCl \< 30 mL/min, on dialysis, Lenalidomide 15 mg 3 times a week from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Group C Lenalidomide 10 mg/Day
CrCl \< 30 mL/min, on dialysis, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Group C Lenalidomide 15 mg/Day
CrCl \< 30 mL/min, on dialysis, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Group C Lenalidomide 25 mg/Day
CrCl \< 30 mL/min, on dialysis, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
| Group | Source count |
|---|---|
| Group A Lenalidomide 10 mg/Day | 6 |
| Group A Lenalidomide 15 mg/Day | 3 |
| Group A Lenalidomide 25 mg/Day | 6 |
| Group A Expansion Cohort | 14 |
| Group B Lenalidomide 15 mg/2 Days | 3 |
| Group B Lenalidomide 25 mg/2 Days | 3 |
| Group B Lenalidomide 15 mg/Day | 3 |
| Group B Lenalidomide 25 mg/Day | 8 |
| Group B Expansion Cohort | 2 |
| Group C Lenalidomide 15 mg 3x/Week | 3 |
| Group C Lenalidomide 10 mg/Day | 3 |
| Group C Lenalidomide 15 mg/Day | 3 |
| Group C Lenalidomide 25 mg/Day | 5 |
Reported measurements
None
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A Lenalidomide 10 mg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 15 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 25 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group A Expansion Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/2 Days | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/2 Days | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Expansion Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg 3x/Week | 3 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 10 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 25 mg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A Lenalidomide 10 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 15 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 25 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group A Expansion Cohort | 4 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/2 Days | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/2 Days | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Expansion Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg 3x/Week | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 10 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 25 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A Lenalidomide 10 mg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 15 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 25 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group A Expansion Cohort | 3 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/2 Days | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/2 Days | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
| Group B Expansion Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg 3x/Week | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 10 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 25 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A Lenalidomide 10 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 15 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 25 mg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
| Group A Expansion Cohort | 6 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/2 Days | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/2 Days | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
| Group B Expansion Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg 3x/Week | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 10 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 25 mg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A Lenalidomide 10 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 15 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 25 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group A Expansion Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/2 Days | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/2 Days | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group B Expansion Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg 3x/Week | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 10 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 25 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A Lenalidomide 10 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 15 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group A Lenalidomide 25 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group A Expansion Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/2 Days | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/2 Days | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 15 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Lenalidomide 25 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group B Expansion Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg 3x/Week | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 10 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 15 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Group C Lenalidomide 25 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- None
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 2
- title
- Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 1
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 0
- title
- Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- units
- Participants
- description
- The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.
- groups
- description
- CrCl 30-60 mL/min, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
- id
- OG000
- title
- Group A Lenalidomide 10 mg/Day
- description
- CrCl 30-60 mL/min, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
- id
- OG001
- title
- Group A Lenalidomide 15 mg/Day
- description
- CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
- id
- OG002
- title
- Group A Lenalidomide 25 mg/Day
- description
- CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
- id
- OG003
- title
- Group A Expansion Cohort
- description
- CrCl \< 30 mL/min, not on dialysis. Lenalidomide days 15 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
- id
- OG004
- title
- Group B Lenalidomide 15 mg/2 Days
- description
- CrCl \< 30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
- id
- OG005
- title
- Group B Lenalidomide 25 mg/2 Days
- description
- CrCl \< 30 mL/min, not on dialysis. Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
- id
- OG006
- title
- Group B Lenalidomide 15 mg/Day
- description
- CrCl \< 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
- id
- OG007
- title
- Group B Lenalidomide 25 mg/Day
- description
- CrCl \< 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
- id
- OG008
- title
- Group B Expansion Cohort
- description
- CrCl \< 30 mL/min, on dialysis, Lenalidomide 15 mg 3 times a week from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
- id
- OG009
- title
- Group C Lenalidomide 15 mg 3x/Week
- description
- CrCl \< 30 mL/min, on dialysis, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
- id
- OG010
- title
- Group C Lenalidomide 10 mg/Day
- description
- CrCl \< 30 mL/min, on dialysis, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
- id
- OG011
- title
- Group C Lenalidomide 15 mg/Day
- param Type
- NUMBER
- population Description
- All patients who started treatment
- reporting Status
- POSTED
- time Frame
- 56 months
- title
- Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice