TriangleNCT00844649 · OUTCOME
Number of Participants With Dose Delays/Doses Not Given
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- number of dose delays
- Interval / dispersion
- Not reported
- Time frame
- Up to 666 days
What was measured
The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.
Analysis population: Treated Population
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
At least 1 ABI-007 dose delay/Not given
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 300 | Not reported | Not reported | Not reported | Not reported |
| Gemcitabine | 0 | Not reported | Not reported | Not reported | Not reported |
At least ≥ 1 Gem dose delay/Not given
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 295 | Not reported | Not reported | Not reported | Not reported |
| Gemcitabine | 230 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 300
- group Id
- OG001
- value
- 0
- title
- At least 1 ABI-007 dose delay/Not given
- categories
- measurements
- group Id
- OG000
- value
- 295
- group Id
- OG001
- value
- 230
- title
- At least ≥ 1 Gem dose delay/Not given
- denoms
- counts
- group Id
- OG000
- value
- 421
- group Id
- OG001
- value
- 402
- units
- Participants
- description
- The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.
- 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
- Treated Population
- reporting Status
- POSTED
- time Frame
- Up to 666 days
- title
- Number of Participants With Dose Delays/Doses Not Given
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- number of dose delays
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice