TriangleNCT05397171 · OUTCOME
Percentage Change From Baseline in Tumor Size
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Percentage change in tumor size
- Interval / dispersion
- Full Range
- Time frame
- Baseline (pre-treatment) up to Week 6 and Week 15
What was measured
Tumor size was the sum of the longest diameters (or short axis measurements for lymph nodes) of the target lesions (TLs). Percentage change in tumor size was determined for participants with measurable disease at baseline. Baseline for Response evaluation criteria in solid tumors (RECIST) version 1.1 was defined as the last evaluable assessment prior to first IP dose. This outcome measure was assessed only for substudy 1 Part A.
Analysis population: Response evaluable set included all dosed participants who had measurable disease at baseline. Here, "n" (number analyzed in each raw) signifies the participants with available data that were analyzed for each timepoint for this outcome measure.
Groups in this outcome
AZD8853 300 mg
Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
AZD8853 1000 mg
Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
AZD8853 3000 mg
Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
| Group | Source count |
|---|---|
| AZD8853 300 mg | 3 |
| AZD8853 1000 mg | 6 |
| AZD8853 3000 mg | 6 |
Reported measurements
Week 6
| Group | Source count |
|---|---|
| AZD8853 300 mg | 3 |
| AZD8853 1000 mg | 6 |
| AZD8853 3000 mg | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AZD8853 300 mg | 10.1 | Not reported | -0.9 | 16.7 | Not reported |
| AZD8853 1000 mg | 10.9 | Not reported | -0.9 | 41.4 | Not reported |
| AZD8853 3000 mg | 14.9 | Not reported | 1.5 | 37.4 | Not reported |
Week 15
| Group | Source count |
|---|---|
| AZD8853 300 mg | 1 |
| AZD8853 1000 mg | 1 |
| AZD8853 3000 mg | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AZD8853 300 mg | 46.5 | Not reported | 46.5 | 46.5 | Not reported |
| AZD8853 1000 mg | 5.7 | Not reported | 5.7 | 5.7 | Not reported |
| AZD8853 3000 mg | 70.0 | Not reported | 13.2 | 126.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.9
- upper Limit
- 16.7
- value
- 10.1
- group Id
- OG001
- lower Limit
- -0.9
- upper Limit
- 41.4
- value
- 10.9
- group Id
- OG002
- lower Limit
- 1.5
- upper Limit
- 37.4
- value
- 14.9
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- units
- Participants
- title
- Week 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.5
- upper Limit
- 46.5
- value
- 46.5
- group Id
- OG001
- lower Limit
- 5.7
- upper Limit
- 5.7
- value
- 5.7
- group Id
- OG002
- lower Limit
- 13.2
- upper Limit
- 126.7
- value
- 70.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Week 15
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Tumor size was the sum of the longest diameters (or short axis measurements for lymph nodes) of the target lesions (TLs). Percentage change in tumor size was determined for participants with measurable disease at baseline. Baseline for Response evaluation criteria in solid tumors (RECIST) version 1.1 was defined as the last evaluable assessment prior to first IP dose. This outcome measure was assessed only for substudy 1 Part A.
- dispersion Type
- Full Range
- groups
- description
- Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- AZD8853 300 mg
- description
- Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
- id
- OG001
- title
- AZD8853 1000 mg
- description
- Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
- id
- OG002
- title
- AZD8853 3000 mg
- param Type
- MEDIAN
- population Description
- Response evaluable set included all dosed participants who had measurable disease at baseline. Here, "n" (number analyzed in each raw) signifies the participants with available data that were analyzed for each timepoint for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline (pre-treatment) up to Week 6 and Week 15
- title
- Percentage Change From Baseline in Tumor Size
- type
- SECONDARY
- unit Of Measure
- Percentage change in tumor size
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice