TriangleNCT01421186 · OUTCOME
Time to Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- patients were observed for up to 36 months
What was measured
Time to Progression (Kaplan Meier estimate)
Analysis population: safety population
Groups in this outcome
Part A: MOR03087 Biweekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
Part B: MOR03087 Weekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
| Group | Source count |
|---|---|
| Part A: MOR03087 Biweekly Dose Escalation | 31 |
| Part B: MOR03087 Weekly Dose Escalation | 4 |
| Part C: MOR03087 Plus Dexamethasone | 18 |
| Part D: MOR03087 Plus Pomalidomide + Dexamethasone | 21 |
| Part E: MOR03087 Plus Lenalidomide + Dexamethasone | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: MOR03087 Biweekly Dose Escalation | 1.1 | Not reported | 1.0 | 1.4 | Not reported |
| Part B: MOR03087 Weekly Dose Escalation | 2.1 | Not reported | 0.7 | NA | Upper confidence limit could not be estimated due to low number of patients with an event. |
| Part C: MOR03087 Plus Dexamethasone | 8.4 | Not reported | 1.4 | 11.1 | Not reported |
| Part D: MOR03087 Plus Pomalidomide + Dexamethasone | 15.9 | Not reported | 4.1 | 25.8 | Not reported |
| Part E: MOR03087 Plus Lenalidomide + Dexamethasone | 33.2 | Not reported | 5.1 | NA | Upper confidence limit could not be estimated due to low number of patients with an event. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 1.4
- value
- 1.1
- comment
- Upper confidence limit could not be estimated due to low number of patients with an event.
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- NA
- value
- 2.1
- group Id
- OG002
- lower Limit
- 1.4
- upper Limit
- 11.1
- value
- 8.4
- group Id
- OG003
- lower Limit
- 4.1
- upper Limit
- 25.8
- value
- 15.9
- comment
- Upper confidence limit could not be estimated due to low number of patients with an event.
- group Id
- OG004
- lower Limit
- 5.1
- upper Limit
- NA
- value
- 33.2
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 17
- units
- Participants
- description
- Time to Progression (Kaplan Meier estimate)
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
- id
- OG000
- title
- Part A: MOR03087 Biweekly Dose Escalation
- description
- Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
- id
- OG001
- title
- Part B: MOR03087 Weekly Dose Escalation
- description
- Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
- id
- OG002
- title
- Part C: MOR03087 Plus Dexamethasone
- description
- Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
- id
- OG003
- title
- Part D: MOR03087 Plus Pomalidomide + Dexamethasone
- description
- Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
- id
- OG004
- title
- Part E: MOR03087 Plus Lenalidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- safety population
- reporting Status
- POSTED
- time Frame
- patients were observed for up to 36 months
- title
- Time to Progression
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice