NCT00316225 · OUTCOME
Overview of Adverse Events
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen · Source last updated 2010-07-09
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, up to 18 weeks
What was measured
Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Analysis population: Patients who received at least one dose of study drug.
Groups in this outcome
Pemetrexed
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
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 |
|---|
| Pemetrexed | 31 |
|---|
Reported measurements
TEAE - All, regardless of causality
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pemetrexed | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE - Possibly related to study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pemetrexed | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
SAE - All, regardless of causality
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pemetrexed | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
SAE - Possibly related to study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pemetrexed | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Discontinuations Due to SAEs (including death)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pemetrexed | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Discontinuations - Possibly related to study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pemetrexed | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Discontinuations Due to Nonserious AEs
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pemetrexed | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Deaths - On Study
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pemetrexed | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Deaths - Possibly related to study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pemetrexed | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Deaths - Within 30 days of Study Discontinuation
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pemetrexed | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- TEAE - All, regardless of causality
- title
- TEAE - Possibly related to study drug
- title
- SAE - All, regardless of causality
- title
- SAE - Possibly related to study drug
- title
- Discontinuations Due to SAEs (including death)
- title
- Discontinuations - Possibly related to study drug
- title
- Discontinuations Due to Nonserious AEs
- title
- Deaths - On Study
- title
- Deaths - Possibly related to study drug
- title
- Deaths - Within 30 days of Study Discontinuation
- description
- Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- groups
- description
- Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
- id
- OG000
- title
- Pemetrexed
- param Type
- NUMBER
- population Description
- Patients who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- baseline, up to 18 weeks
- title
- Overview of Adverse Events
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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