NCT00686959 · OUTCOME
Adverse Events: The Number of Deaths Per Treatment Group
Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer · Source last updated 2016-06-28
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
- Baseline through 30 Days Post Study
What was measured
The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related \[poss related\] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Analysis population: All randomized participants who received at least one dose of study drug.
Groups in this outcome
Arm A: Pemetrexed + Cisplatin and TRT
Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
Arm B: Etoposide + Cisplatin and TRT
Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 283 |
|---|
| Arm B: Etoposide + Cisplatin and TRT | 272 |
|---|
Reported measurements
On study drug (total)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Etoposide + Cisplatin and TRT | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
On study drug: Due to AE
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Etoposide + Cisplatin and TRT | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
On study drug: Due to AE poss related
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Etoposide + Cisplatin and TRT | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
On study drug: Due to study disease
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Etoposide + Cisplatin and TRT | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Within 30 Days of Discontinuation (disc) (total)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Etoposide + Cisplatin and TRT | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Within 30 Days of Disc: Due to AE
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Etoposide + Cisplatin and TRT | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Within 30 Days of Disc: Due to AE poss related
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Etoposide + Cisplatin and TRT | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Within 30 Days of Disc: Due to study disease
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Etoposide + Cisplatin and TRT | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- title
- On study drug (total)
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 4
- title
- On study drug: Due to AE
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- title
- On study drug: Due to AE poss related
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- On study drug: Due to study disease
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- title
- Within 30 Days of Discontinuation (disc) (total)
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- title
- Within 30 Days of Disc: Due to AE
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Within 30 Days of Disc: Due to AE poss related
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- title
- Within 30 Days of Disc: Due to study disease
- denoms
- counts
- group Id
- OG000
- value
- 283
- group Id
- OG001
- value
- 272
- units
- Participants
- description
- The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related \[poss related\] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
- groups
- description
- Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
- id
- OG000
- title
- Arm A: Pemetrexed + Cisplatin and TRT
- description
- Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
- id
- OG001
- title
- Arm B: Etoposide + Cisplatin and TRT
- param Type
- NUMBER
- population Description
- All randomized participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Baseline through 30 Days Post Study
- title
- Adverse Events: The Number of Deaths Per Treatment Group
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice
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