TriangleNCT00331760 · OUTCOME
Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events
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
- 95% Confidence Interval
- Time frame
- From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
What was measured
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.
Analysis population: Eligible patients who started study treatment
Groups in this outcome
Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
| Group | Source count |
|---|---|
| Endometrial Cancer: IMRT | 43 |
| Cervical Cancer: IMRT + Chemotherapy (Cisplatin) | 40 |
Reported measurements
Non-hematologic
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Endometrial Cancer: IMRT | 12 | Not reported | 5 | 25 | Not reported |
| Cervical Cancer: IMRT + Chemotherapy (Cisplatin) | 10 | Not reported | 3 | 24 | Not reported |
Overall
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Endometrial Cancer: IMRT | 12 | Not reported | 5 | 25 | Not reported |
| Cervical Cancer: IMRT + Chemotherapy (Cisplatin) | 10 | Not reported | 3 | 24 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5
- upper Limit
- 25
- value
- 12
- group Id
- OG001
- lower Limit
- 3
- upper Limit
- 24
- value
- 10
- title
- Non-hematologic
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5
- upper Limit
- 25
- value
- 12
- group Id
- OG001
- lower Limit
- 3
- upper Limit
- 24
- value
- 10
- title
- Overall
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
- id
- OG000
- title
- Endometrial Cancer: IMRT
- description
- Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
- id
- OG001
- title
- Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
- param Type
- NUMBER
- population Description
- Eligible patients who started study treatment
- reporting Status
- POSTED
- time Frame
- From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
- title
- Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice