NCT00369564 · OUTCOME
Types of Neurotoxicities
Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer · Source last updated 2021-08-11
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
- 10 Weeks
What was measured
Types of neurotoxicities reported. Each patient was only counted once for each type of neurotoxicity, but a patient could be counted in more than 1 type of neurotoxicity. For example, if a patient experienced constipation 3 times, they are included once for constipation. If a patient experienced sensory changes and motor changes, they are included once for sensory changes and once for motor changes.
Analysis population: Participants who returned a post baseline Neurotox Questionnaire
Groups in this outcome
Arm I Glutamic Acid
Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
Arm II Placebo
Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
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 |
|---|
| Arm I Glutamic Acid | 127 |
|---|
| Arm II Placebo | 123 |
|---|
Reported measurements
Constipation
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I Glutamic Acid | 97 |
|---|
| Arm II Placebo | 107 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I Glutamic Acid | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II Placebo | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
Sensory Changes
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I Glutamic Acid | 97 |
|---|
| Arm II Placebo | 107 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I Glutamic Acid | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II Placebo | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Motor Changes
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I Glutamic Acid | 97 |
|---|
| Arm II Placebo | 107 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I Glutamic Acid | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II Placebo | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Jaw Pain
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I Glutamic Acid | 97 |
|---|
| Arm II Placebo | 107 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I Glutamic Acid | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Laryngeal Nerve Dysfunction
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I Glutamic Acid | 97 |
|---|
| Arm II Placebo | 107 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I Glutamic Acid | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 14
- denoms
- counts
- group Id
- OG000
- value
- 97
- group Id
- OG001
- value
- 107
- units
- Participants
- title
- Constipation
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 97
- group Id
- OG001
- value
- 107
- units
- Participants
- title
- Sensory Changes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 97
- group Id
- OG001
- value
- 107
- units
- Participants
- title
- Motor Changes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 97
- group Id
- OG001
- value
- 107
- units
- Participants
- title
- Jaw Pain
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 97
- group Id
- OG001
- value
- 107
- units
- Participants
- title
- Laryngeal Nerve Dysfunction
- denoms
- counts
- group Id
- OG000
- value
- 127
- group Id
- OG001
- value
- 123
- units
- Participants
- description
- Types of neurotoxicities reported. Each patient was only counted once for each type of neurotoxicity, but a patient could be counted in more than 1 type of neurotoxicity. For example, if a patient experienced constipation 3 times, they are included once for constipation. If a patient experienced sensory changes and motor changes, they are included once for sensory changes and once for motor changes.
- groups
- description
- Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
- id
- OG000
- title
- Arm I Glutamic Acid
- description
- Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
- id
- OG001
- title
- Arm II Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who returned a post baseline Neurotox Questionnaire
- reporting Status
- POSTED
- time Frame
- 10 Weeks
- title
- Types of Neurotoxicities
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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