NCT01196390 · OUTCOME
Frequency of Highest Grade Adverse Event Per Participant
Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer · Source last updated 2026-06-02
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
What was measured
Common Terminology Criteria for Adverse Events (version 4.0 before 4-1-2018; then version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data provided is in this outcome measure; see Adverse Events Module for specific adverse event data.
Analysis population: Eligible participants who started study treatment
Groups in this outcome
Chemoradiation and Trastuzumab
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
Chemoradiation
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
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 |
|---|
| Chemoradiation and Trastuzumab | 95 |
|---|
| Chemoradiation | 96 |
|---|
Reported measurements
All Adverse Events
Grade 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemoradiation | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemoradiation | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemoradiation | 56 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemoradiation | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemoradiation | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Reported as Definitely, Probably, or Possibly Related to Protocol Treatment
Grade 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemoradiation | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemoradiation | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemoradiation | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemoradiation | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemoradiation | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 1
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 12
- title
- Grade 2
- measurements
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 56
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 25
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- title
- Grade 5
- title
- All Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Grade 1
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 20
- title
- Grade 2
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 52
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 21
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- title
- Grade 5
- title
- Reported as Definitely, Probably, or Possibly Related to Protocol Treatment
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 96
- units
- Participants
- description
- Common Terminology Criteria for Adverse Events (version 4.0 before 4-1-2018; then version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data provided is in this outcome measure; see Adverse Events Module for specific adverse event data.
- groups
- description
- Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
- id
- OG000
- title
- Chemoradiation and Trastuzumab
- description
- Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
- id
- OG001
- title
- Chemoradiation
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Eligible participants who started study treatment
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
- title
- Frequency of Highest Grade Adverse Event Per Participant
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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