TriangleNCT00102804 · OUTCOME
Number of Participants With Adverse Events (AEs)
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 to study completion (up to 41 Months)
What was measured
Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Analysis population: Participants who signed the ICF, completed the randomized process and received at least 1 dose of study drug are reported according to the treatment to which they were received.
Groups in this outcome
Pemetrexed and BSC
Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
Placebo and BSC
Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
| Group | Source count |
|---|---|
| Pemetrexed and BSC | 438 |
| Placebo and BSC | 218 |
Reported measurements
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pemetrexed and BSC | 83 | Not reported | Not reported | Not reported | Not reported |
| Placebo and BSC | 31 | Not reported | Not reported | Not reported | Not reported |
Other Non-Serious AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pemetrexed and BSC | 386 | Not reported | Not reported | Not reported | Not reported |
| Placebo and BSC | 178 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 31
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 386
- group Id
- OG001
- value
- 178
- title
- Other Non-Serious AEs
- denoms
- counts
- group Id
- OG000
- value
- 438
- group Id
- OG001
- value
- 218
- units
- Participants
- description
- Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
- groups
- description
- Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- id
- OG000
- title
- Pemetrexed and BSC
- description
- Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- id
- OG001
- title
- Placebo and BSC
- param Type
- NUMBER
- population Description
- Participants who signed the ICF, completed the randomized process and received at least 1 dose of study drug are reported according to the treatment to which they were received.
- reporting Status
- POSTED
- time Frame
- Baseline to study completion (up to 41 Months)
- title
- Number of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice