NCT01847274 · OUTCOME
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer · Source last updated 2023-06-02
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
- At Baseline
What was measured
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit"). Baseline was latest non-missing pre-dose assessment on or before randomization date.
Analysis population: Intent-to-treat Population.
Groups in this outcome
gBRCA Niraparib
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
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 |
|---|
| gBRCA Niraparib | 138 |
|---|
| gBRCA Placebo | 65 |
|---|
Reported measurements
Feet, 0-Not at all
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
Feet, 1-A little bit
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 32 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Feet, 2-Somewhat
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Feet, 3-Quite a bit
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Feet, 4-Very much
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Hands, 0-Not at all
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 80 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
Hands, 1-A little bit
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Hands, 2-Somewhat
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Hands, 3-Quite a bit
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Hands, 4-Very much
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7969
- statistical Comment
- Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
- statistical Method
- Pearson's Chi-squared test
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8794
- statistical Comment
- Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
- statistical Method
- Pearson's Chi-squared test
Complete source fields
- analyses
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7969
- statistical Comment
- Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
- statistical Method
- Pearson's Chi-squared test
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8794
- statistical Comment
- Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
- statistical Method
- Pearson's Chi-squared test
- classes
- categories
- measurements
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 26
- title
- Feet, 0-Not at all
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 12
- title
- Feet, 1-A little bit
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 9
- title
- Feet, 2-Somewhat
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 10
- title
- Feet, 3-Quite a bit
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 6
- title
- Feet, 4-Very much
- categories
- measurements
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 37
- title
- Hands, 0-Not at all
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 13
- title
- Hands, 1-A little bit
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 6
- title
- Hands, 2-Somewhat
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 5
- title
- Hands, 3-Quite a bit
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- Hands, 4-Very much
- denoms
- counts
- group Id
- OG000
- value
- 138
- group Id
- OG001
- value
- 65
- units
- Participants
- description
- A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit"). Baseline was latest non-missing pre-dose assessment on or before randomization date.
- groups
- description
- Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
- id
- OG000
- title
- gBRCA Niraparib
- description
- Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
- id
- OG001
- title
- gBRCA Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Intent-to-treat Population.
- reporting Status
- POSTED
- time Frame
- At Baseline
- title
- Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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