NCT02773030 · OUTCOME
Number of Participants With Treatment Related Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Approximately on average of (Cohort A: 16.23 Cohort B: 10.32 Cohort D: 18.68 Cohort E: 15.65 Cohort F: 12.66 Cohort G: 16.03 Cohort H1: 17.22 Cohort H2: 21.07 Cohort I: 17.10 Cohort J: 20.56 Cohort K: 13.56) Months
What was measured
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Analysis population: All participants who were treated with CC-220
Groups in this outcome
Cohort A: Treatment 1
CC220 0.30mg
Cohort A: Treatment 2
CC220 0.45mg
Cohort A: Treatment 3
CC220 0.60mg
Cohort A: Treatment 4
CC220 0.75mg
Cohort A: Treatment 5
CC220 0.90mg
Cohort A: Treatment 6
CC220 1.0mg
Cohort B: Treatment 1
CC220 0.30mg + DEX
Cohort B: Treatment 2
CC220 0.45mg + DEX
Cohort B: Treatment 3
CC220 0.60mg + DEX
Cohort B: Treatment 4
CC220 0.75mg + DEX
Cohort B: Treatment 5
CC220 0.90mg + DEX
Cohort B: Treatment 6
CC220 1.0mg + DEX
Cohort B: Treatment 7
CC220 1.1mg + DEX
Cohort B: Treatment 8
CC220 1.2mg + DEX
Cohort B: Treatment 9
CC220 1.3.mg + DEX
Cohort B: Treatment 10
CC220 1.6mg + DEX
Cohort D: Treatment 1
CC220 + DEX
Cohort E: Treatment 1
CC220 1.0mg + DARA + DEX
Cohort E: Treatment 2
CC220 1.1mg + DARA + DEX
Cohort E: Treatment 3
CC220 1.2mg + DARA + DEX
Cohort E: Treatment 4
CC220 1.3mg + DARA + DEX
Cohort E: Treatment 5
CC220 1.6mg + DARA + DEX
Cohort F: Treatment 1
CC220 1.0mg + BORT + DEX
Cohort F: Treatment 2
CC220 1.1mg + BORT + DEX
Cohort F: Treatment 3
CC220 1.3mg + BORT + DEX
Cohort F: Treatment 4
CC220 1.6mg + BORT + DEX
Cohort G: Treatment 1
CC220 1.1mg + CFZ + DEX
Cohort G: Treatment 2
CC220 1.3mg + CFZ + DEX
Cohort G: Treatment 3
CC220 1.6mg + CFZ + DEX
Cohort H1
CC220 + DEX
Cohort H2
CC220 + DEX
Cohort I
CC220 + DEX
Cohort J1: Treatment 1
CC220Vd 1.0mg + NE-ASCT
Cohort J1: Treatment 2
CC220Vd 1.6mg + NE-ASCT
Cohort K: Treatment 1
CC220 1.0mg + DARA + DEX
Cohort K: Treatment 2
CC220 1.3mg + DARA + DEX
Cohort K: Treatment 3
CC220 1.6mg + DARA + DEX
| Group | Source count |
|---|---|
| Cohort A: Treatment 1 | 3 |
| Cohort A: Treatment 2 | 3 |
| Cohort A: Treatment 3 | 4 |
| Cohort A: Treatment 4 | 6 |
| Cohort A: Treatment 5 | 6 |
| Cohort A: Treatment 6 | 7 |
| Cohort B: Treatment 1 | 10 |
| Cohort B: Treatment 2 | 3 |
| Cohort B: Treatment 3 | 3 |
| Cohort B: Treatment 4 | 3 |
| Cohort B: Treatment 5 | 13 |
| Cohort B: Treatment 6 | 13 |
| Cohort B: Treatment 7 | 10 |
| Cohort B: Treatment 8 | 8 |
| Cohort B: Treatment 9 | 14 |
| Cohort B: Treatment 10 | 13 |
| Cohort D: Treatment 1 | 107 |
| Cohort E: Treatment 1 | 3 |
| Cohort E: Treatment 2 | 3 |
| Cohort E: Treatment 3 | 5 |
| Cohort E: Treatment 4 | 13 |
| Cohort E: Treatment 5 | 26 |
| Cohort F: Treatment 1 | 3 |
| Cohort F: Treatment 2 | 7 |
| Cohort F: Treatment 3 | 10 |
| Cohort F: Treatment 4 | 9 |
| Cohort G: Treatment 1 | 4 |
| Cohort G: Treatment 2 | 8 |
| Cohort G: Treatment 3 | 4 |
| Cohort H1 | 6 |
| Cohort H2 | 5 |
| Cohort I | 41 |
| Cohort J1: Treatment 1 | 1 |
| Cohort J1: Treatment 2 | 17 |
| Cohort K: Treatment 1 | 25 |
| Cohort K: Treatment 2 | 25 |
| Cohort K: Treatment 3 | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: Treatment 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort A: Treatment 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort A: Treatment 3 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort A: Treatment 4 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort A: Treatment 5 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort A: Treatment 6 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Treatment 1 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Treatment 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Treatment 3 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Treatment 4 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Treatment 5 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Treatment 6 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Treatment 7 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Treatment 8 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Treatment 9 | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Treatment 10 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort D: Treatment 1 | 95 | Not reported | Not reported | Not reported | Not reported |
| Cohort E: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort E: Treatment 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort E: Treatment 3 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort E: Treatment 4 | 12 | Not reported | Not reported | Not reported | Not reported |
| Cohort E: Treatment 5 | 23 | Not reported | Not reported | Not reported | Not reported |
| Cohort F: Treatment 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort F: Treatment 2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort F: Treatment 3 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort F: Treatment 4 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort G: Treatment 1 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort G: Treatment 2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort G: Treatment 3 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort H1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort H2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort I | 30 | Not reported | Not reported | Not reported | Not reported |
| Cohort J1: Treatment 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort J1: Treatment 2 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cohort K: Treatment 1 | 24 | Not reported | Not reported | Not reported | Not reported |
| Cohort K: Treatment 2 | 24 | Not reported | Not reported | Not reported | Not reported |
| Cohort K: Treatment 3 | 23 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 9
- group Id
- OG011
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 13
- group Id
- OG011
- value
- 13
- units
- Participants
- description
- An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
- groups
- description
- CC220 0.30mg
- id
- OG000
- title
- Cohort A: Treatment 1
- description
- CC220 0.45mg
- id
- OG001
- title
- Cohort A: Treatment 2
- description
- CC220 0.60mg
- id
- OG002
- title
- Cohort A: Treatment 3
- description
- CC220 0.75mg
- id
- OG003
- title
- Cohort A: Treatment 4
- description
- CC220 0.90mg
- id
- OG004
- title
- Cohort A: Treatment 5
- description
- CC220 1.0mg
- id
- OG005
- title
- Cohort A: Treatment 6
- description
- CC220 0.30mg + DEX
- id
- OG006
- title
- Cohort B: Treatment 1
- description
- CC220 0.45mg + DEX
- id
- OG007
- title
- Cohort B: Treatment 2
- description
- CC220 0.60mg + DEX
- id
- OG008
- title
- Cohort B: Treatment 3
- description
- CC220 0.75mg + DEX
- id
- OG009
- title
- Cohort B: Treatment 4
- description
- CC220 0.90mg + DEX
- id
- OG010
- title
- Cohort B: Treatment 5
- description
- CC220 1.0mg + DEX
- id
- OG011
- title
- Cohort B: Treatment 6
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who were treated with CC-220
- reporting Status
- POSTED
- time Frame
- Approximately on average of (Cohort A: 16.23 Cohort B: 10.32 Cohort D: 18.68 Cohort E: 15.65 Cohort F: 12.66 Cohort G: 16.03 Cohort H1: 17.22 Cohort H2: 21.07 Cohort I: 17.10 Cohort J: 20.56 Cohort K: 13.56) Months
- title
- Number of Participants With Treatment Related Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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