TriangleNCT00844649 · OUTCOME
Number of Participants With Dose Interruptions
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Maximum time on treatment was 666 days
What was measured
The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Analysis population: Safety population, includes participants who received at least one study treatment
Groups in this outcome
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine
Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
| Group | Source count |
|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 421 |
| Gemcitabine | 402 |
Reported measurements
≥ 1 Albumin-bound paclitaxel dose interruption
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 2 | Not reported | Not reported | Not reported | Not reported |
| Gemcitabine | 0 | Not reported | Not reported | Not reported | Not reported |
At least 1 Gemcitabine dose interruption
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 8 | Not reported | Not reported | Not reported | Not reported |
| Gemcitabine | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- ≥ 1 Albumin-bound paclitaxel dose interruption
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- title
- At least 1 Gemcitabine dose interruption
- denoms
- counts
- group Id
- OG000
- value
- 421
- group Id
- OG001
- value
- 402
- units
- Participants
- description
- The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
- groups
- description
- Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
- id
- OG000
- title
- Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
- description
- Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
- id
- OG001
- title
- Gemcitabine
- param Type
- NUMBER
- population Description
- Safety population, includes participants who received at least one study treatment
- reporting Status
- POSTED
- time Frame
- Maximum time on treatment was 666 days
- title
- Number of Participants With Dose Interruptions
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice