TriangleNCT00556322 · OUTCOME
Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
What was measured
EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC.Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as At least a 20 % increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Analysis population: FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative
Groups in this outcome
Comparator
Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Erlotinib
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
| Group | Source count |
|---|---|
| Comparator | 188 |
| Erlotinib | 175 |
Reported measurements
EGFR Positive (n=149,143)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Comparator | 79.9 | Not reported | Not reported | Not reported | Not reported |
| Erlotinib | 93.7 | Not reported | Not reported | Not reported | Not reported |
EGFR Negative (n=39,32)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Comparator | 89.7 | Not reported | Not reported | Not reported | Not reported |
| Erlotinib | 90.6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 79.9
- group Id
- OG001
- value
- 93.7
- title
- EGFR Positive (n=149,143)
- categories
- measurements
- group Id
- OG000
- value
- 89.7
- group Id
- OG001
- value
- 90.6
- title
- EGFR Negative (n=39,32)
- denoms
- counts
- group Id
- OG000
- value
- 188
- group Id
- OG001
- value
- 175
- units
- Participants
- description
- EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC.Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as At least a 20 % increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- groups
- description
- Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
- id
- OG000
- title
- Comparator
- description
- Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
- id
- OG001
- title
- Erlotinib
- param Type
- NUMBER
- population Description
- FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative
- reporting Status
- POSTED
- time Frame
- Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
- title
- Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice