TriangleNCT02773849 · OUTCOME
Number of Patients With a Complete Response Rate Based on Patients With Carcinoma in Situ (CIS), With or Without Concomitant High-grade Ta or T1 Papillary Disease.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 12 Months
What was measured
A patient in the CIS cohort was judged to have achieved CR where urine cytology was reported as normal, atypical, degenerative, reactive, inflammatory, or nonspecific AND cystoscopy was reported as normal or with findings that did not include evidence of low-grade or high-grade recurrence. Bladder biopsy, if performed (not mandatory), demonstrated an absence of low-grade or high-grade recurrence.
Analysis population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
Groups in this outcome
Carcinoma in Situ
CIS participants had at entry, confirmed by a pathology report: Carcinoma in situ (CIS) only or Ta/T1 highgrade disease with concomitant CIS AND were "BCG unresponsive" which referred to patients with highgrade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG. The term "BCG unresponsive" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with CIS within 12 months of their last intravesical treatment with BCG or relapsed with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.
| Group | Source count |
|---|---|
| Carcinoma in Situ | 103 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carcinoma in Situ | 55 | Not reported | 43.3 | 63.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.3
- upper Limit
- 63.3
- value
- 55
- denoms
- counts
- group Id
- OG000
- value
- 103
- units
- Participants
- description
- A patient in the CIS cohort was judged to have achieved CR where urine cytology was reported as normal, atypical, degenerative, reactive, inflammatory, or nonspecific AND cystoscopy was reported as normal or with findings that did not include evidence of low-grade or high-grade recurrence. Bladder biopsy, if performed (not mandatory), demonstrated an absence of low-grade or high-grade recurrence.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- CIS participants had at entry, confirmed by a pathology report: Carcinoma in situ (CIS) only or Ta/T1 highgrade disease with concomitant CIS AND were "BCG unresponsive" which referred to patients with highgrade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG. The term "BCG unresponsive" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with CIS within 12 months of their last intravesical treatment with BCG or relapsed with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.
- id
- OG000
- title
- Carcinoma in Situ
- param Type
- NUMBER
- population Description
- Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- 12 Months
- title
- Number of Patients With a Complete Response Rate Based on Patients With Carcinoma in Situ (CIS), With or Without Concomitant High-grade Ta or T1 Papillary Disease.
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice