NCT02773030 · OUTCOME
Duration of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- Full Range
- Time frame
- On Average of (Cohort A:161.33, Cohort B: 63.74, Cohort D: 39.16, Cohort E: 89.56, Cohort F: 69.24, Cohort G: 80.93, Cohort H1: 77.11, Cohort H2: 42.71, Cohort I: 36.80, Cohort J: 92.36, Cohort K: 51.85) Weeks
What was measured
Duration of response is defined as time from the earliest date of documented response (PR or better) to the earliest date of disease progression per IMWG Uniform Response Criteria or death, whichever occurred first. Participants who do not have progression of disease or death will be censored on the last adequate response assessment date. Duration of response for responders will be summarized using Kaplan-Meier estimates by cohort and dose level as appropriate. Data will be collected and analyzed per Cohort Totals.
Analysis population: Safety Population - As per protocol, DOR and PFS will combine arms in the cohort for endpoint presentation
Groups in this outcome
Cohort A: Total
CC220
Cohort B: Total
CC220 + DEX
Cohort D: Total
CC220
Cohort E: Total
CC220 + DARA + DEX
Cohort F: Total
CC220 + BORT + DEX
Cohort G: Total
CC220 + CFZ + DEX
Cohort H1
CC220 + DEX
Cohort H2
CC220 + DEX
Cohort I
CC220 + DEX
Cohort J: Total
CC220 + NE-ASCT
Cohort K
CC220 + DARA + DEX
| Group | Source count |
|---|---|
| Cohort A: Total | 3 |
| Cohort B: Total | 29 |
| Cohort D: Total | 28 |
| Cohort E: Total | 24 |
| Cohort F: Total | 17 |
| Cohort G: Total | 10 |
| Cohort H1 | 4 |
| Cohort H2 | 1 |
| Cohort I | 14 |
| Cohort J: Total | 16 |
| Cohort K | 71 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: Total | 176.14 | Not reported | 40.7 | 267.1 | Not reported |
| Cohort B: Total | 45.00 | Not reported | 7.4 | 239.3 | Not reported |
| Cohort D: Total | 28.64 | Not reported | 2.9 | 146.1 | Not reported |
| Cohort E: Total | 59.21 | Not reported | 9.1 | 265.1 | Not reported |
| Cohort F: Total | 69.29 | Not reported | 6.6 | 255.1 | Not reported |
| Cohort G: Total | 66.64 | Not reported | 22.7 | 238.3 | Not reported |
| Cohort H1 | 43.57 | Not reported | 12.1 | 209.1 | Not reported |
| Cohort H2 | 42.71 | Not reported | 42.71 | 42.71 | Not reported |
| Cohort I | 32.79 | Not reported | 8.0 | 80.1 | Not reported |
| Cohort J: Total | 104.71 | Not reported | 17.0 | 123.1 | Not reported |
| Cohort K | 52.14 | Not reported | 21.0 | 77.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 40.7
- upper Limit
- 267.1
- value
- 176.14
- group Id
- OG001
- lower Limit
- 7.4
- upper Limit
- 239.3
- value
- 45.00
- group Id
- OG002
- lower Limit
- 2.9
- upper Limit
- 146.1
- value
- 28.64
- group Id
- OG003
- lower Limit
- 9.1
- upper Limit
- 265.1
- value
- 59.21
- group Id
- OG004
- lower Limit
- 6.6
- upper Limit
- 255.1
- value
- 69.29
- group Id
- OG005
- lower Limit
- 22.7
- upper Limit
- 238.3
- value
- 66.64
- group Id
- OG006
- lower Limit
- 12.1
- upper Limit
- 209.1
- value
- 43.57
- group Id
- OG007
- lower Limit
- 42.71
- upper Limit
- 42.71
- value
- 42.71
- group Id
- OG008
- lower Limit
- 8.0
- upper Limit
- 80.1
- value
- 32.79
- group Id
- OG009
- lower Limit
- 17.0
- upper Limit
- 123.1
- value
- 104.71
- group Id
- OG010
- lower Limit
- 21.0
- upper Limit
- 77.3
- value
- 52.14
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 28
- group Id
- OG003
- value
- 24
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 14
- group Id
- OG009
- value
- 16
- group Id
- OG010
- value
- 71
- units
- Participants
- description
- Duration of response is defined as time from the earliest date of documented response (PR or better) to the earliest date of disease progression per IMWG Uniform Response Criteria or death, whichever occurred first. Participants who do not have progression of disease or death will be censored on the last adequate response assessment date. Duration of response for responders will be summarized using Kaplan-Meier estimates by cohort and dose level as appropriate. Data will be collected and analyzed per Cohort Totals.
- dispersion Type
- Full Range
- groups
- description
- CC220
- id
- OG000
- title
- Cohort A: Total
- description
- CC220 + DEX
- id
- OG001
- title
- Cohort B: Total
- description
- CC220
- id
- OG002
- title
- Cohort D: Total
- description
- CC220 + DARA + DEX
- id
- OG003
- title
- Cohort E: Total
- description
- CC220 + BORT + DEX
- id
- OG004
- title
- Cohort F: Total
- description
- CC220 + CFZ + DEX
- id
- OG005
- title
- Cohort G: Total
- description
- CC220 + DEX
- id
- OG006
- title
- Cohort H1
- description
- CC220 + DEX
- id
- OG007
- title
- Cohort H2
- description
- CC220 + DEX
- id
- OG008
- title
- Cohort I
- description
- CC220 + NE-ASCT
- id
- OG009
- title
- Cohort J: Total
- description
- CC220 + DARA + DEX
- id
- OG010
- title
- Cohort K
- param Type
- MEDIAN
- population Description
- Safety Population - As per protocol, DOR and PFS will combine arms in the cohort for endpoint presentation
- reporting Status
- POSTED
- time Frame
- On Average of (Cohort A:161.33, Cohort B: 63.74, Cohort D: 39.16, Cohort E: 89.56, Cohort F: 69.24, Cohort G: 80.93, Cohort H1: 77.11, Cohort H2: 42.71, Cohort I: 36.80, Cohort J: 92.36, Cohort K: 51.85) Weeks
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- Weeks
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Preserved source evidence · Not medical advice
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