TriangleNCT02514239 · OUTCOME
The Number of Patients With Dose-limiting Toxicities (DLTs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1, up to 6 weeks.
What was measured
The number of patients with Dose-limiting toxicities (DLTs) in cycle 1. A Dose-limiting toxicity was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
Analysis population: MTD evaluation set (MTDS): all patients who were administered trial medication and who were not replaced for the Maximum tolerated dose (MTD) determination.
Groups in this outcome
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
| Group | Source count |
|---|---|
| Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d) | 4 |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (13 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (25 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (50 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (100 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (200 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (400 μg/d) | 6 |
| Intravenous Infusion of BI 836909 (800 μg/d) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 3
- units
- Participants
- description
- The number of patients with Dose-limiting toxicities (DLTs) in cycle 1. A Dose-limiting toxicity was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
- groups
- description
- Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG000
- title
- Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
- description
- Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG001
- title
- Intravenous Infusion of BI 836909 (3.2 μg/d)
- description
- Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG002
- title
- Intravenous Infusion of BI 836909 (6.5 μg/d)
- description
- Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG003
- title
- Intravenous Infusion of BI 836909 (13 μg/d)
- description
- Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG004
- title
- Intravenous Infusion of BI 836909 (25 μg/d)
- description
- Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG005
- title
- Intravenous Infusion of BI 836909 (50 μg/d)
- description
- Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG006
- title
- Intravenous Infusion of BI 836909 (100 μg/d)
- description
- Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG007
- title
- Intravenous Infusion of BI 836909 (200 μg/d)
- description
- Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG008
- title
- Intravenous Infusion of BI 836909 (400 μg/d)
- description
- Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG009
- title
- Intravenous Infusion of BI 836909 (800 μg/d)
- param Type
- NUMBER
- population Description
- MTD evaluation set (MTDS): all patients who were administered trial medication and who were not replaced for the Maximum tolerated dose (MTD) determination.
- reporting Status
- POSTED
- time Frame
- Cycle 1, up to 6 weeks.
- title
- The Number of Patients With Dose-limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice