NCT02516241 · OUTCOME
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab, Safety Analysis Set - ADA Evaluable Patients
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer · Source last updated 2026-07-14
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
- At week 0, 4, 12 and 24, and at follow-up Month 3.
What was measured
Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Durvalumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline.
Analysis population: ADA evaluable patients is defined as patients in the safety analysis set who have a non-missing baseline ADA and at least one non-missing post-baseline result
Groups in this outcome
Combination Therapy
MEDI4736 (Durvalumab) + Tremelimumab
Monotherapy
MEDI4736 (Durvalumab)
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 |
|---|
| Combination Therapy | 340 |
|---|
| Monotherapy | 345 |
|---|
Reported measurements
ADA evaluable patients
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy | 340 |
|---|
| Monotherapy | 345 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy | 293 | Not reported | Not reported | Not reported | Not reported |
|---|
| Monotherapy | 302 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA positive at any visit (ADA Prevalence)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy | 293 |
|---|
| Monotherapy | 302 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
| Monotherapy | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-emergent ADA positive (ADA Incidence)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy | 293 |
|---|
| Monotherapy | 302 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Monotherapy | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-boosted ADA
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy | 293 |
|---|
| Monotherapy | 302 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Monotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-induced ADA (Positive Post-baseline only)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy | 293 |
|---|
| Monotherapy | 302 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Monotherapy | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA Positive at Baseline only
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy | 293 |
|---|
| Monotherapy | 302 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Monotherapy | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA Positive Post-baseline and Positive at Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy | 293 |
|---|
| Monotherapy | 302 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Monotherapy | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Persistently Positive
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy | 293 |
|---|
| Monotherapy | 302 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Monotherapy | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Transiently Positive
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy | 293 |
|---|
| Monotherapy | 302 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Monotherapy | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
nAb Positive at any visit
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy | 293 |
|---|
| Monotherapy | 302 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Monotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 293
- group Id
- OG001
- value
- 302
- denoms
- counts
- group Id
- OG000
- value
- 340
- group Id
- OG001
- value
- 345
- units
- Participants
- title
- ADA evaluable patients
- categories
- measurements
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 31
- denoms
- counts
- group Id
- OG000
- value
- 293
- group Id
- OG001
- value
- 302
- units
- Participants
- title
- ADA positive at any visit (ADA Prevalence)
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 293
- group Id
- OG001
- value
- 302
- units
- Participants
- title
- Treatment-emergent ADA positive (ADA Incidence)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 293
- group Id
- OG001
- value
- 302
- units
- Participants
- title
- Treatment-boosted ADA
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 293
- group Id
- OG001
- value
- 302
- units
- Participants
- title
- Treatment-induced ADA (Positive Post-baseline only)
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 18
- denoms
- counts
- group Id
- OG000
- value
- 293
- group Id
- OG001
- value
- 302
- units
- Participants
- title
- ADA Positive at Baseline only
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 293
- group Id
- OG001
- value
- 302
- units
- Participants
- title
- ADA Positive Post-baseline and Positive at Baseline
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 293
- group Id
- OG001
- value
- 302
- units
- Participants
- title
- Persistently Positive
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 293
- group Id
- OG001
- value
- 302
- units
- Participants
- title
- Transiently Positive
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 293
- group Id
- OG001
- value
- 302
- units
- Participants
- title
- nAb Positive at any visit
- denoms
- counts
- group Id
- OG000
- value
- 340
- group Id
- OG001
- value
- 345
- units
- Participants
- description
- Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Durvalumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline.
- groups
- description
- MEDI4736 (Durvalumab) + Tremelimumab
- id
- OG000
- title
- Combination Therapy
- description
- MEDI4736 (Durvalumab)
- id
- OG001
- title
- Monotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- ADA evaluable patients is defined as patients in the safety analysis set who have a non-missing baseline ADA and at least one non-missing post-baseline result
- reporting Status
- POSTED
- time Frame
- At week 0, 4, 12 and 24, and at follow-up Month 3.
- title
- Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab, Safety Analysis Set - ADA Evaluable Patients
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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