NCT02773849 · OUTCOME
Anti-adenoviral Antibody Levels for Correlation to Response Rate
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
- 12 Months
What was measured
Measurement of anti-adenoviral antibody levels at each dosing period, withdrawal, and at 12 months were done. A patient was considered to have a positive immunogenic response in anti-adenoviral antibodies if a post-baseline titration demonstrated a greater than a 2-fold dilution increase from baseline. The table represent data at any time during the 12 months period, which means that the patients were included in the Yes group if they at any measurement during the trial had a 2-fold dilution increase from baseline.
Analysis population: Patients with Positive Immunogenic Response in Anti-Adenoviral Antibodies at Post-Baseline based on patients who had achieved High-Grade Recurrence Free Survival at 12 months
Groups in this outcome
Carcinoma in Situ
Patients with Carcinoma in situ (CIS) with or without concomitant high-grade Ta or T1 papillary disease
Papillary Disease
Patients with high-grade Ta or T1 papillary disease (without concomitant CIS)
Total
All patients
| Group | Source count |
|---|---|
| Carcinoma in Situ | 89 |
| Papillary Disease | 45 |
| Total | 134 |
Reported measurements
Yes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carcinoma in Situ | 63 | Not reported | Not reported | Not reported | Not reported |
| Papillary Disease | 34 | Not reported | Not reported | Not reported | Not reported |
| Total | 97 | Not reported | Not reported | Not reported | Not reported |
No
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carcinoma in Situ | 26 | Not reported | Not reported | Not reported | Not reported |
| Papillary Disease | 11 | Not reported | Not reported | Not reported | Not reported |
| Total | 37 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 97
- title
- Yes
- categories
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 37
- title
- No
- denoms
- counts
- group Id
- OG000
- value
- 89
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 134
- units
- Participants
- description
- Measurement of anti-adenoviral antibody levels at each dosing period, withdrawal, and at 12 months were done. A patient was considered to have a positive immunogenic response in anti-adenoviral antibodies if a post-baseline titration demonstrated a greater than a 2-fold dilution increase from baseline. The table represent data at any time during the 12 months period, which means that the patients were included in the Yes group if they at any measurement during the trial had a 2-fold dilution increase from baseline.
- groups
- description
- Patients with Carcinoma in situ (CIS) with or without concomitant high-grade Ta or T1 papillary disease
- id
- OG000
- title
- Carcinoma in Situ
- description
- Patients with high-grade Ta or T1 papillary disease (without concomitant CIS)
- id
- OG001
- title
- Papillary Disease
- description
- All patients
- id
- OG002
- title
- Total
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Patients with Positive Immunogenic Response in Anti-Adenoviral Antibodies at Post-Baseline based on patients who had achieved High-Grade Recurrence Free Survival at 12 months
- reporting Status
- POSTED
- time Frame
- 12 Months
- title
- Anti-adenoviral Antibody Levels for Correlation to Response Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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