TriangleNCT00833833 · OUTCOME
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off
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 104
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 1: 2 mg Pomalidomide
Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Phase 1: 3 mg Pomalidomide
Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Phase 1: 4 mg Pomalidomide
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.
Phase 1: 5 mg Pomalidomide
Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
| Group | Source count |
|---|---|
| Phase 1: 2 mg Pomalidomide | 6 |
| Phase 1: 3 mg Pomalidomide | 8 |
| Phase 1: 4 mg Pomalidomide | 14 |
| Phase 1: 5 mg Pomalidomide | 10 |
Reported measurements
1 or more (1+) AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg Pomalidomide | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 3 mg Pomalidomide | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 4 mg Pomalidomide | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 5 mg Pomalidomide | 100.0 | Not reported | Not reported | Not reported | Not reported |
1+ AE related to pomalidomide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg Pomalidomide | 66.7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 3 mg Pomalidomide | 75.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 4 mg Pomalidomide | 85.7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 5 mg Pomalidomide | 100.0 | Not reported | Not reported | Not reported | Not reported |
1+ severity grade 3-4 AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg Pomalidomide | 83.3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 3 mg Pomalidomide | 37.5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 4 mg Pomalidomide | 78.6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 5 mg Pomalidomide | 80.0 | Not reported | Not reported | Not reported | Not reported |
1+ severity grade 3-4 AE related to pomalidomide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg Pomalidomide | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 3 mg Pomalidomide | 25.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 4 mg Pomalidomide | 42.9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 5 mg Pomalidomide | 70.0 | Not reported | Not reported | Not reported | Not reported |
1+ serious AE (SAE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg Pomalidomide | 50.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 3 mg Pomalidomide | 12.5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 4 mg Pomalidomide | 42.9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 5 mg Pomalidomide | 30.0 | Not reported | Not reported | Not reported | Not reported |
1+ SAE related to pomalidomide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg Pomalidomide | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 3 mg Pomalidomide | 12.5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 4 mg Pomalidomide | 7.1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 5 mg Pomalidomide | 10.0 | Not reported | Not reported | Not reported | Not reported |
1+ AE leading to discontinuation of pomalidomide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg Pomalidomide | 16.7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 3 mg Pomalidomide | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 4 mg Pomalidomide | 21.4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 5 mg Pomalidomide | 0.0 | Not reported | Not reported | Not reported | Not reported |
1+AE-dose reduction/interruption of pomalidomide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg Pomalidomide | 16.7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 3 mg Pomalidomide | 75.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 4 mg Pomalidomide | 42.9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 5 mg Pomalidomide | 80.0 | Not reported | Not reported | Not reported | Not reported |
1+related AE-reduction/interruption of pomalidomid
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg Pomalidomide | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 3 mg Pomalidomide | 37.5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 4 mg Pomalidomide | 28.6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 5 mg Pomalidomide | 70.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 100.0
- title
- 1 or more (1+) AE
- categories
- measurements
- group Id
- OG000
- value
- 66.7
- group Id
- OG001
- value
- 75.0
- group Id
- OG002
- value
- 85.7
- group Id
- OG003
- value
- 100.0
- title
- 1+ AE related to pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 83.3
- group Id
- OG001
- value
- 37.5
- group Id
- OG002
- value
- 78.6
- group Id
- OG003
- value
- 80.0
- title
- 1+ severity grade 3-4 AE
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 25.0
- group Id
- OG002
- value
- 42.9
- group Id
- OG003
- value
- 70.0
- title
- 1+ severity grade 3-4 AE related to pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 50.0
- group Id
- OG001
- value
- 12.5
- group Id
- OG002
- value
- 42.9
- group Id
- OG003
- value
- 30.0
- title
- 1+ serious AE (SAE)
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 12.5
- group Id
- OG002
- value
- 7.1
- group Id
- OG003
- value
- 10.0
- title
- 1+ SAE related to pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 16.7
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 21.4
- group Id
- OG003
- value
- 0.0
- title
- 1+ AE leading to discontinuation of pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 16.7
- group Id
- OG001
- value
- 75.0
- group Id
- OG002
- value
- 42.9
- group Id
- OG003
- value
- 80.0
- title
- 1+AE-dose reduction/interruption of pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 37.5
- group Id
- OG002
- value
- 28.6
- group Id
- OG003
- value
- 70.0
- title
- 1+related AE-reduction/interruption of pomalidomid
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 10
- 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
- Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
- id
- OG000
- title
- Phase 1: 2 mg Pomalidomide
- description
- Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
- id
- OG001
- title
- Phase 1: 3 mg Pomalidomide
- 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.
- id
- OG002
- title
- Phase 1: 4 mg Pomalidomide
- description
- Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
- id
- OG003
- title
- Phase 1: 5 mg Pomalidomide
- 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 104
- title
- Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice