TriangleNCT02099539 · OUTCOME
Immunogenicity - Anti-drug Antibody (ADA)
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
- From Baseline up to Week 12
What was measured
Number of patients with a positive Anti-drug Antibody (ADA) result
Analysis population: Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects
Groups in this outcome
Cohort 1: N-803 - IV 1 ug/kg
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
Cohort 2: N-803 - IV 3 ug/kg
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
Cohort 3: N-803 - IV 6 ug/kg
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
Cohort 4: N-803 - IV 10 ug/kg
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
Cohort 5: N-803 - SQ 10 ug/kg
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
Cohort 6: N-803 - SQ 15 ug/kg
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
| Group | Source count |
|---|---|
| Cohort 1: N-803 - IV 1 ug/kg | 2 |
| Cohort 2: N-803 - IV 3 ug/kg | 3 |
| Cohort 3: N-803 - IV 6 ug/kg | 1 |
| Cohort 4: N-803 - IV 10 ug/kg | 2 |
| Cohort 5: N-803 - SQ 10 ug/kg | 3 |
| Cohort 6: N-803 - SQ 15 ug/kg | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: N-803 - IV 1 ug/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: N-803 - IV 3 ug/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: N-803 - IV 6 ug/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: N-803 - IV 10 ug/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: N-803 - SQ 10 ug/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: N-803 - SQ 15 ug/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
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- Number of patients with a positive Anti-drug Antibody (ADA) result
- groups
- description
- N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
- id
- OG000
- title
- Cohort 1: N-803 - IV 1 ug/kg
- description
- N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
- id
- OG001
- title
- Cohort 2: N-803 - IV 3 ug/kg
- description
- N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
- id
- OG002
- title
- Cohort 3: N-803 - IV 6 ug/kg
- description
- N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
- id
- OG003
- title
- Cohort 4: N-803 - IV 10 ug/kg
- description
- N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
- id
- OG004
- title
- Cohort 5: N-803 - SQ 10 ug/kg
- description
- N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
- id
- OG005
- title
- Cohort 6: N-803 - SQ 15 ug/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects
- reporting Status
- POSTED
- time Frame
- From Baseline up to Week 12
- title
- Immunogenicity - Anti-drug Antibody (ADA)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice