NCT01847274 · OUTCOME
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6
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 Cycle 6 (Each cycle was of 28 days)
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").
Analysis population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
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 | 105 |
|---|
| gBRCA Placebo | 41 |
|---|
Reported measurements
Feet, 0-Not at all
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| gBRCA Niraparib | 44 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 17 | 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 | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 5 | 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 | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 7 | 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 | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 5 | 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 | 2 | 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 | 54 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 21 | 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 | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 8 | 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 | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 4 | 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 | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 2 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| gBRCA Placebo | 1 | 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
- 0.8521
- statistical Comment
- Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
- statistical Method
- Pearson's Chi-squared test
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9923
- 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
- 0.8521
- statistical Comment
- Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
- statistical Method
- Pearson's Chi-squared test
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9923
- statistical Comment
- Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
- statistical Method
- Pearson's Chi-squared test
- classes
- categories
- measurements
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 17
- title
- Feet, 0-Not at all
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 5
- title
- Feet, 1-A little bit
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 7
- title
- Feet, 2-Somewhat
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 5
- title
- Feet, 3-Quite a bit
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 2
- title
- Feet, 4-Very much
- categories
- measurements
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 21
- title
- Hands, 0-Not at all
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 8
- title
- Hands, 1-A little bit
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 4
- title
- Hands, 2-Somewhat
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- title
- Hands, 3-Quite a bit
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Hands, 4-Very much
- denoms
- counts
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 41
- 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").
- 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. Only those participants with data available at the indicated time points were analyzed.
- reporting Status
- POSTED
- time Frame
- At Cycle 6 (Each cycle was of 28 days)
- title
- Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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