TriangleNCT00516503 · OUTCOME
Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0
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
- Up to 4 weeks
What was measured
Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
Analysis population: All patients that were assessed for adverse events are used in this analysis.
Groups in this outcome
Baclofen-amitriptyline Hydrochloride-ketamine
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Placebo
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
| Group | Source count |
|---|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 101 |
| Placebo | 102 |
Reported measurements
Grade 3+ Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 8 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 5 | Not reported | Not reported | Not reported | Not reported |
Grade 4+ Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 1 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- title
- Grade 3+ Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Grade 4+ Adverse Event
- denoms
- counts
- group Id
- OG000
- value
- 101
- group Id
- OG001
- value
- 102
- units
- Participants
- description
- Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
- groups
- description
- Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
- id
- OG000
- title
- Baclofen-amitriptyline Hydrochloride-ketamine
- description
- Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All patients that were assessed for adverse events are used in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to 4 weeks
- title
- Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice