NCT00833833 · OUTCOME
Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off
MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-04-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to week 70
What was measured
Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
Data collection is ongoing and future data results will be included as available.
Analysis population: Safety population.
Data collection is ongoing and future data results will be included as available.
Groups in this outcome
Phase 2: Pomalidomide + Dexamethasone
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
Phase 2: Pomalidomide (Pom Only)
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added.
Phase 2: Pomalidomide (Pom + Dex Only)
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone.
Phase 2: Pomalidomide (Overall)
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone.
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 |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 112 |
|---|
| Phase 2: Pomalidomide (Pom Only) | 107 |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 61 |
|---|
| Phase 2: Pomalidomide (Overall) | 107 |
|---|
Reported measurements
1 or more (1+) AE
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 99.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 93.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
1+ AE related to pomalidomide
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 89.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 87.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 68.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 88.8 | Not reported | Not reported | Not reported | Not reported |
|---|
1+ severity grade 3-4 AE
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 88.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 84.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 70.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 89.7 | Not reported | Not reported | Not reported | Not reported |
|---|
1+ severity grade 3-4 AE related to pomalidomide
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 62.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 58.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 44.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 67.3 | Not reported | Not reported | Not reported | Not reported |
|---|
1+ serious AE (SAE)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 61.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 46.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 47.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 67.3 | Not reported | Not reported | Not reported | Not reported |
|---|
1+ SAE related to pomalidomide
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 17.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 9.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 19.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 20.6 | Not reported | Not reported | Not reported | Not reported |
|---|
1+ AE leading to discontinuation of pomalidomide
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 8.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 10.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 3.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 12.1 | Not reported | Not reported | Not reported | Not reported |
|---|
1+related AE --discontinuation of pomalidomide
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 1.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 2.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 1.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 3.7 | Not reported | Not reported | Not reported | Not reported |
|---|
1+AE - reduction of pomalidomide
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 20.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 25.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 9.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 29.9 | Not reported | Not reported | Not reported | Not reported |
|---|
1+ AE - interruption of pomalidomide
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 63.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 47.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 36.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 58.9 | Not reported | Not reported | Not reported | Not reported |
|---|
1+ related AE - interruption of pomalidomide
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 27.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 24.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 21.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 32.7 | Not reported | Not reported | Not reported | Not reported |
|---|
1+related AE - reduction of pomalidomide
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 17.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom Only) | 20.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Pom + Dex Only) | 8.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pomalidomide (Overall) | 24.3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 99.1
- group Id
- OG002
- value
- 93.4
- group Id
- OG003
- value
- 100.0
- title
- 1 or more (1+) AE
- categories
- measurements
- group Id
- OG000
- value
- 89.3
- group Id
- OG001
- value
- 87.9
- group Id
- OG002
- value
- 68.9
- group Id
- OG003
- value
- 88.8
- title
- 1+ AE related to pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 88.4
- group Id
- OG001
- value
- 84.1
- group Id
- OG002
- value
- 70.5
- group Id
- OG003
- value
- 89.7
- title
- 1+ severity grade 3-4 AE
- categories
- measurements
- group Id
- OG000
- value
- 62.5
- group Id
- OG001
- value
- 58.9
- group Id
- OG002
- value
- 44.3
- group Id
- OG003
- value
- 67.3
- title
- 1+ severity grade 3-4 AE related to pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 61.6
- group Id
- OG001
- value
- 46.7
- group Id
- OG002
- value
- 47.5
- group Id
- OG003
- value
- 67.3
- title
- 1+ serious AE (SAE)
- categories
- measurements
- group Id
- OG000
- value
- 17.9
- group Id
- OG001
- value
- 9.3
- group Id
- OG002
- value
- 19.7
- group Id
- OG003
- value
- 20.6
- title
- 1+ SAE related to pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 8.0
- group Id
- OG001
- value
- 10.3
- group Id
- OG002
- value
- 3.3
- group Id
- OG003
- value
- 12.1
- title
- 1+ AE leading to discontinuation of pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 1.8
- group Id
- OG001
- value
- 2.8
- group Id
- OG002
- value
- 1.6
- group Id
- OG003
- value
- 3.7
- title
- 1+related AE --discontinuation of pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 20.5
- group Id
- OG001
- value
- 25.2
- group Id
- OG002
- value
- 9.8
- group Id
- OG003
- value
- 29.9
- title
- 1+AE - reduction of pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 63.4
- group Id
- OG001
- value
- 47.7
- group Id
- OG002
- value
- 36.1
- group Id
- OG003
- value
- 58.9
- title
- 1+ AE - interruption of pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 27.7
- group Id
- OG001
- value
- 24.3
- group Id
- OG002
- value
- 21.3
- group Id
- OG003
- value
- 32.7
- title
- 1+ related AE - interruption of pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 17.9
- group Id
- OG001
- value
- 20.6
- group Id
- OG002
- value
- 8.2
- group Id
- OG003
- value
- 24.3
- title
- 1+related AE - reduction of pomalidomide
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 107
- group Id
- OG002
- value
- 61
- group Id
- OG003
- value
- 107
- units
- Participants
- description
- Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
Data collection is ongoing and future data results will be included as available.
- groups
- description
- Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG000
- title
- Phase 2: Pomalidomide + Dexamethasone
- description
- Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added.
- id
- OG001
- title
- Phase 2: Pomalidomide (Pom Only)
- description
- Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone.
- id
- OG002
- title
- Phase 2: Pomalidomide (Pom + Dex Only)
- description
- Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone.
- id
- OG003
- title
- Phase 2: Pomalidomide (Overall)
- param Type
- NUMBER
- population Description
- Safety population.
Data collection is ongoing and future data results will be included as available.
- reporting Status
- POSTED
- time Frame
- Up to week 70
- title
- Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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