NCT02125461 · OUTCOME
Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer · Source last updated 2023-10-10
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
- Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO.
What was measured
ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay.
Analysis population: ADA evaluable population included patients who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results.
Groups in this outcome
Durvalumab (MEDI4736)
Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
Placebo
Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Durvalumab (MEDI4736) | 416 |
|---|
| Placebo | 204 |
|---|
Reported measurements
ADA positive at any visit
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA positive post-baseline only
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-boosted ADA positive
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA positive at baseline and post-baseline
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA positive at baseline only
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA persistently positive
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA transient positive
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutralizing antibodies positive at any visit
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 10
- title
- ADA positive at any visit
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- title
- ADA positive post-baseline only
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Treatment-boosted ADA positive
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- title
- ADA positive at baseline and post-baseline
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 3
- title
- ADA positive at baseline only
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- title
- ADA persistently positive
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- title
- ADA transient positive
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- Neutralizing antibodies positive at any visit
- denoms
- counts
- group Id
- OG000
- value
- 416
- group Id
- OG001
- value
- 204
- units
- Participants
- description
- ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay.
- groups
- description
- Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
- id
- OG000
- title
- Durvalumab (MEDI4736)
- description
- Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- ADA evaluable population included patients who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results.
- reporting Status
- POSTED
- time Frame
- Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO.
- title
- Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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