TriangleNCT00701103 · OUTCOME
Percentage of Participants Who Experienced One or More 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
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 3 weeks
What was measured
Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.
Analysis population: The population consisted of all participants who received at least one dose of study drug.
Groups in this outcome
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
| Group | Source count |
|---|---|
| Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL) | 5 |
| Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL) | 3 |
| Dalotuzumab 5 mg/kg Q1W (10 mg/mL) | 8 |
| Dalotuzumab 10 mg/kg Q1W (10 mg/mL) | 6 |
| Dalotuzumab 10 mg/kg Q1W (20 mg/mL) | 6 |
| Dalotuzumab 15 mg/kg Q1W (10 mg/mL) | 6 |
| Dalotuzumab 15 mg/kg Q1W (20 mg/mL) | 8 |
| Dalotuzumab 20 mg/kg Q1W (10 mg/mL) | 7 |
| Dalotuzumab 20 mg/kg Q1W (20 mg/mL) | 9 |
| Dalotuzumab 20 mg/kg Q2W (20 mg/mL) | 11 |
| Dalotuzumab 30 mg/kg Q3W (20 mg/mL) | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 5 mg/kg Q1W (10 mg/mL) | 13 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 10 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 10 mg/kg Q1W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 15 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 15 mg/kg Q1W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q1W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q2W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 30 mg/kg Q3W (20 mg/mL) | 0 | 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
- 13
- 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
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 11
- units
- Participants
- description
- Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.
- groups
- description
- Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG000
- title
- Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG001
- title
- Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG002
- title
- Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG003
- title
- Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
- id
- OG004
- title
- Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
- description
- Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG005
- title
- Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
- id
- OG006
- title
- Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
- description
- Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG007
- title
- Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
- id
- OG008
- title
- Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
- description
- Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
- id
- OG009
- title
- Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
- description
- Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
- id
- OG010
- title
- Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
- param Type
- NUMBER
- population Description
- The population consisted of all participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Up to 3 weeks
- title
- Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice