TriangleNCT01885897 · OUTCOME
Number of Participants With Excessive Toxicity
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
- 4 weeks
What was measured
To evaluate the safety of the ALT-803 when administered on this schedule. Excessive toxicity is defined as having a grade 3-5 non-hematologic, non-relapse and non-infectious toxicity (except fevers alone) based on the NCI's CTCAE version 4.
Groups in this outcome
ALT-803, IV, 1 mcg/kg
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
ALT-803, IV, 3 mcg/kg
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
ALT-803, IV, 6 mcg/kg
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
ALT-803, IV, 10 mcg/kg
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
ALT-803, SQ, 6 mcg/kg
Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
ALT-803, SQ, 10 mcg/kg
Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
| Group | Source count |
|---|---|
| ALT-803, IV, 1 mcg/kg | 6 |
| ALT-803, IV, 3 mcg/kg | 3 |
| ALT-803, IV, 6 mcg/kg | 4 |
| ALT-803, IV, 10 mcg/kg | 3 |
| ALT-803, SQ, 6 mcg/kg | 8 |
| ALT-803, SQ, 10 mcg/kg | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALT-803, IV, 1 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ALT-803, IV, 3 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ALT-803, IV, 6 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ALT-803, IV, 10 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ALT-803, SQ, 6 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ALT-803, SQ, 10 mcg/kg | 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
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 9
- units
- Participants
- description
- To evaluate the safety of the ALT-803 when administered on this schedule. Excessive toxicity is defined as having a grade 3-5 non-hematologic, non-relapse and non-infectious toxicity (except fevers alone) based on the NCI's CTCAE version 4.
- groups
- description
- Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
- id
- OG000
- title
- ALT-803, IV, 1 mcg/kg
- description
- Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
- id
- OG001
- title
- ALT-803, IV, 3 mcg/kg
- description
- Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
- id
- OG002
- title
- ALT-803, IV, 6 mcg/kg
- description
- Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
- id
- OG003
- title
- ALT-803, IV, 10 mcg/kg
- description
- Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
- id
- OG004
- title
- ALT-803, SQ, 6 mcg/kg
- description
- Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
- id
- OG005
- title
- ALT-803, SQ, 10 mcg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 4 weeks
- title
- Number of Participants With Excessive Toxicity
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice