Chemotherapy-Induced Peripheral Neuropathy
Conditions
Keywords
Pain, chemotherapy
Brief summary
Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.
Detailed description
This study was terminated on July 15, 2008. The results of an interim analysis showed that the conditional power to detect a difference in treatment groups was insufficient to warrant study continuation and therefore termination of the trial was recommended. The decision to terminate the trial was not based on safety concerns.
Interventions
DRUGPregabalin
150- 600 mg/day (double blind in divided doses)
DRUGPlacebo
Placebo
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of cytological confirmed carcinoma of the Colon Stage III (Dukes C) or metastatic Colorectal Cancer (Dukes D) * Independent of this protocol, the patient has decided to receive standard of care for the treatment of cancer with oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA) for a minimum of 9 cycles
Exclusion criteria
* Presence of neuropathic pain or peripheral polyneuropathy or identified causes of painful paresthesia including radiotherapy-induced or malignant plexopathy, lumbar or cervical radiculopathy existing prior to baseline * Any patients who are not suitable to be treated with either Oxaliplatin and/or 5-FU/FA or pregabalin according to the respective local labeling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS) | Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF) | Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Baseline to Cycle 9 | Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). |
| Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Baseline to Cycle 9, LOCF cycle endpoint | Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). |
| Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Baseline to Cycle 9, LOCF cycle endpoint | Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). |
| Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint | Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours. |
| Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint | Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: \>=1: mild symptoms to \>=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime. |
Countries
Australia, Germany, Italy, South Korea, Spain, Taiwan
Participant flow
Pre-assignment details
Of the 69 subjects screened, 64 were randomized, and 61 received treatment. Of the 8 subjects screened but not treated, 1 was ineligible due to an abnormal laboratory test result, 6 were ineligible due to a reason categorized as other, and 1 was no longer willing to continue in the study.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day \[BID\]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID). | 32 |
| Placebo matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). | 29 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 7 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Not related to study drug | 3 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Pregabalin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 11.3 | 56.1 years STANDARD_DEVIATION 12.9 | 57.6 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 31 / 32 | 27 / 29 |
| serious Total, serious adverse events | 5 / 32 | 7 / 29 |
Outcome results
Primary
Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)
Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days).
Time frame: Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)
Population: Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained; Last Observation Carried Forward (LOCF): last recorded cycle. Primary analysis timeframe: 10 days of paresthesia scores from the onset of chemotherapy to the last cycle of chemotherapy (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS) | 1.11 score on scale | Standard Error 0.35 |
| Placebo | Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS) | 1.27 score on scale | Standard Error 0.34 |
Comparison: LOCF cycle endpoint. Sample size based on original primary efficacy parameter (PEP) of time to persistent symptoms (developing in 35% of pregabalin subjects \& 60% of placebo subjects). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, study would have had at least 90% power using 100 subjects per treatment group. Original PEP was modified to secondary due to lack of persistent paresthetic symptom emergence.p-value: 0.7489ANCOVA
Secondary
Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle
Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours.
Time frame: Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint
Population: ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 8 (n=18,21) | 0.63 score on scale | Standard Error 0.25 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 5 (n=26,24) | 0.06 score on scale | Standard Error 0.08 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 9 (n=18,20) | 0.18 score on scale | Standard Error 0.17 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 8 (n=19,21) | 0.53 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain LOCF endpoint (n=28,27) | 0.11 score on scale | Standard Error 0.1 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 7 (n=32,29) | 0.26 score on scale | Standard Error 0.18 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 2 (n=28,27) | 0.04 score on scale | Standard Error 0.06 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 9 (n=19,20) | 0.54 score on scale | Standard Error 0.28 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 4 (n=28,24) | 0.15 score on scale | Standard Error 0.08 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 2 (n=28,27) | 9.25 score on scale | Standard Error 0.08 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 5 (n=26,24) | 0.18 score on scale | Standard Error 0.14 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain LOCF endpoint (n=29,27) | 0.33 score on scale | Standard Error 0.18 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 6 (n=24,24) | 0.49 score on scale | Standard Error 0.28 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain LOCF endpoint (n=29,27) | 0.15 score on scale | Standard Error 0.06 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 7 (n=21,22) | 0.99 score on scale | Standard Error 0.26 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 2 (n=28,27) | -0.01 score on scale | Standard Error 0.04 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 8 (n=19,20) | 1.05 score on scale | Standard Error 0.36 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 3(n=28,23) | 0.34 score on scale | Standard Error 0.1 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 9 (n=19,20) | 0.74 score on scale | Standard Error 0.26 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 3 (n=28,24) | 0.05 score on scale | Standard Error 0.03 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain LOCF endpoint (n=29,27) | 0.46 score on scale | Standard Error 0.18 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 4 (n=28,24) | 0.43 score on scale | Standard Error 0.11 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 6 (n=24,24) | 0.28 score on scale | Standard Error 0.12 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 5(n=26,24) | 0.60 score on scale | Standard Error 0.15 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 4 (n=28,23) | 0.03 score on scale | Standard Error 0.08 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 6 (n=24,23) | 0.68 score on scale | Standard Error 0.23 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 6(n=22,23) | 0.02 score on scale | Standard Error 0.01 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 7 (n=21,22) | 0.78 score on scale | Standard Error 0.23 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 5 (n=26,24) | 0.06 score on scale | Standard Error 0.04 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 8 (n=19,21) | 1.09 score on scale | Standard Error 0.34 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 3 (n=27,27) | 0.09 score on scale | Standard Error 0.06 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dyesthesia pain Cycle 9 (n=18,20) | 1.17 score on scale | Standard Error 0.36 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 6 (n=24,24) | 0.09 score on scale | Standard Error 0.05 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dyesthesia pain LOCF endpt (n=29,27) | 0.83 score on scale | Standard Error 0.24 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 9 (n=19,20 | 0.25 score on scale | Standard Error 0.09 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 2 (n=27,27) | 0.00 score on scale | Standard Error 0 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 3 (n=27,24) | 0.00 score on scale | Standard Error 0.01 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 3 (n=27,24) | 0.01 score on scale | Standard Error 0 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 8 (n=19,21) | 0.39 score on scale | Standard Error 0.15 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 4(n=27,23) | 0.01 score on scale | Standard Error 0 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 4 (n=28,24) | 0.06 score on scale | Standard Error 0.06 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 5 (n=25,24) | 0.01 score on scale | Standard Error 0 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 4 (n=28,23) | 0.02 score on scale | Standard Error 0.09 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 5 (n=25,24) | 0.06 score on scale | Standard Error 0.07 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 7 (n=18,23) | 0.03 score on scale | Standard Error 0.02 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 6 (n=22,23) | 0.08 score on scale | Standard Error 0.09 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 8(n=18,20) | 0.04 score on scale | Standard Error 0.01 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 3 (n=28,23) | 0.17 score on scale | Standard Error 0.11 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 9 (n=17,20) | 0.03 score on scale | Standard Error 0.01 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 7(n=19,23) | 0.36 score on scale | Standard Error 0.17 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle LOCF Endpoint (n=28,27) | 0.02 score on scale | Standard Error 0.01 |
| Pregabalin | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 7 (n=21,23) | 0.42 score on scale | Standard Error 0.25 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle LOCF Endpoint (n=28,27) | 0.02 score on scale | Standard Error 0.01 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 5 (n=26,24) | 0.19 score on scale | Standard Error 0.08 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 6 (n=24,24) | 0.09 score on scale | Standard Error 0.05 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 7 (n=32,29) | 0.30 score on scale | Standard Error 0.17 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 8 (n=19,21) | 0.12 score on scale | Standard Error 0.15 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 9 (n=19,20 | 0.14 score on scale | Standard Error 0.08 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain LOCF endpoint (n=29,27) | 0.08 score on scale | Standard Error 0.06 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 5 (n=25,24) | 0.017 score on scale | Standard Error 0.07 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 3 (n=28,23) | 0.07 score on scale | Standard Error 0.13 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain LOCF endpoint (n=29,27) | 0.43 score on scale | Standard Error 0.19 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 2 (n=28,27) | -0.00 score on scale | Standard Error 0.09 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 3(n=28,23) | 0.14 score on scale | Standard Error 0.11 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 3 (n=27,27) | -0.02 score on scale | Standard Error 0.06 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 6 (n=24,24) | 0.14 score on scale | Standard Error 0.12 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 7 (n=21,23) | 0.40 score on scale | Standard Error 0.24 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 8 (n=19,21) | 0.23 score on scale | Standard Error 0.21 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 9 (n=19,20) | 0.59 score on scale | Standard Error 0.27 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain LOCF endpoint (n=29,27) | 0.35 score on scale | Standard Error 19 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 2 (n=28,27) | 0.05 score on scale | Standard Error 0.04 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 3 (n=28,24) | 0.01 score on scale | Standard Error 0.03 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 4 (n=28,23) | 0.20 score on scale | Standard Error 0.09 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Pressing spontaneous pain Cycle 5 (n=26,24) | 0.06 score on scale | Standard Error 0.04 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 3 (n=27,24) | 0.02 score on scale | Standard Error 0.01 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 4 (n=28,24) | 0.13 score on scale | Standard Error 0.07 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 6 (n=22,23) | 0.21 score on scale | Standard Error 0.09 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 7(n=19,23) | 0.35 score on scale | Standard Error 0.16 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 8 (n=18,21) | 0.32 score on scale | Standard Error 0.23 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain Cycle 9 (n=18,20) | 0.38 score on scale | Standard Error 0.16 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paroxysmal pain LOCF endpoint (n=28,27) | 0.20 score on scale | Standard Error 0.11 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 2 (n=28,27) | 0.04 score on scale | Standard Error 0.06 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 4 (n=28,24) | 0.28 score on scale | Standard Error 0.09 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 5 (n=26,24) | 0.29 score on scale | Standard Error 0.14 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 6 (n=24,24) | 0.66 score on scale | Standard Error 0.28 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 7 (n=21,22) | 0.40 score on scale | Standard Error 0.26 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 8 (n=19,20) | 0.36 score on scale | Standard Error 0.35 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Evoke pain Cycle 9 (n=19,20) | 0.59 score on scale | Standard Error 0.26 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 4 (n=28,24) | 0.06 score on scale | Standard Error 0.12 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 5(n=26,24) | 0.20 score on scale | Standard Error 0.15 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 6 (n=24,23) | 0.32 score on scale | Standard Error 0.24 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 7 (n=21,22) | 0.48 score on scale | Standard Error 0.22 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dysesthesia pain Cycle 8 (n=19,21) | 0.58 score on scale | Standard Error 0.32 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dyesthesia pain Cycle 9 (n=18,20) | 0.85 score on scale | Standard Error 0.34 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Paresthesia/dyesthesia pain LOCF endpt (n=29,27) | 0.52 score on scale | Standard Error 0.25 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 2 (n=27,27) | 0.00 score on scale | Standard Error 0 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 3 (n=27,24) | 0.00 score on scale | Standard Error 0 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 4(n=27,23) | 0.01 score on scale | Standard Error 0 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 5 (n=25,24) | 0.01 score on scale | Standard Error 0 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 6(n=22,23) | 0.02 score on scale | Standard Error 0.01 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 7 (n=18,23) | 0.02 score on scale | Standard Error 0.01 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 8(n=18,20) | 0.02 score on scale | Standard Error 0.01 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Total Score Cycle 9 (n=17,20) | 0.03 score on scale | Standard Error 0.01 |
| Placebo | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Burning spontaneous pain Cycle 4 (n=28,23) | 0.15 score on scale | Standard Error 0.1 |
Comparison: Burning Spontaneous Pain Cycle 3p-value: 0.203495% CI: [-0.06, 0.29]ANCOVA
Comparison: Burning Spontaneous Pain Cycle 4p-value: 0.306295% CI: [-0.4, 0.13]ANCOVA
Comparison: Burning Spontaneous Pain Cycle 5p-value: 0.278795% CI: [-0.37, 0.11]ANCOVA
Comparison: Burning Spontaneous Pain Cycle 6p-value: 0.412495% CI: [-0.2, 0.47]ANCOVA
Comparison: Burning Spontaneous Pain Cycle 7p-value: 0.954195% CI: [-0.68, 0.73]ANCOVA
Comparison: Burning Spontaneous Pain Cycle 8p-value: 0.338395% CI: [-0.33, 0.92]ANOVA
Comparison: Burning Spontaneous Painp-value: 0.891895% CI: [-0.84, 0.74]ANCOVA
Comparison: Burning Spontaneous Pain LOCF endpointp-value: 0.961495% CI: [-0.54, 0.51]ANCOVA
Comparison: Pressing Spontaneous Pain Cycle 2p-value: 0.302295% CI: [-0.17, 0.05]ANCOVA
Comparison: Pressing Spontaneous Pain Cycle 3p-value: 0.374795% CI: [-0.04, 0.12]ANCOVA
Comparison: Pressing Spontaneous Pain Cycle 4p-value: 0.16395% CI: [-0.4, 0.07]ANCOVA
Comparison: Pressing Spontaneous Pain Cycle 5p-value: 0.956895% CI: [-0.12, 0.11]ANOVA
Comparison: Pressing Spontaneous Pain Cycle 6p-value: 0.979395% CI: [-0.13, 0.13]ANCOVA
Comparison: Pressing Spontaneous Pain Cycle 7p-value: 0.88595% CI: [-0.54, 0.47]ANCOVA
Comparison: Pressing Spontaneous Pain Cycle 8p-value: 0.219995% CI: [-0.17, 0.7]ANCOVA
Comparison: Pressing Spontaneous Pain Cycle 9p-value: 0.401795% CI: [-0.14, 0.35]ANCOVA
Comparison: Pressing Spontaneous Pain LOCF Endpointp-value: 0.411395% CI: [-0.1, 0.24]ANCOVA
Comparison: Paroxysmal Pain Cycle 3p-value: 0.301195% CI: [-0.06, 0.02]ANCOVA
Comparison: Paroxysmal Pain Cycle 4p-value: 0.448295% CI: [-0.26, 0.12]ANCOVA
Comparison: Paroxysmal Pain Cycle 5p-value: 0.305895% CI: [-0.31, 0.1]ANCOVA
Comparison: Paroxysmal Pain Cycle 6p-value: 0.303595% CI: [-0.38, 0.12]ANCOVA
Comparison: Paroxysmal Pain Cycle 7p-value: 0.963695% CI: [-0.46, 0.48]ANCOVA
Comparison: Paroxysmal Pain Cycle 8p-value: 0.36695% CI: [-0.38, 1.02]ANCOVA
Comparison: Paroxysmal Pain Cycle 9p-value: 0.409395% CI: [-0.69, 0.29]ANCOVA
Comparison: Paroxysmal Pain LOCF Endpointp-value: 0.520895% CI: [-0.39, 0.2]ANCOVA
Comparison: Evoke Pain Cycle 2p-value: 0.993195% CI: [-0.17, 0.17]ANCOVA
Comparison: Evoke Pain Cycle 3p-value: 0.586795% CI: [-0.25, 0.44]ANCOVA
Comparison: Evoke Pain Cycle 4p-value: 0.274895% CI: [-0.37, 0.11]ANCOVA
Comparison: Evoke Pain Cycle 5p-value: 0.552195% CI: [-0.51, 0.28]ANCOVA
Comparison: Evoke Pain Cycle 6p-value: 0.673495% CI: [-0.96, 0.62]ANCOVA
Comparison: Evoke Pain Cycle 7p-value: 0.121495% CI: [-0.16, 1.33]ANCOVA
Comparison: Evoke Pain Cycle 8p-value: 0.184595% CI: [-0.34, 1.72]ANCOVA
Comparison: Evoke Pain Cycle 9p-value: 0.686395% CI: [-0.6, 0.9]ANCOVA
Comparison: Evoke Pain LOCF Endpointp-value: 0.927395% CI: [-0.51, 0.56]ANCOVA
Comparison: Parethesia/Dysesthesia Pain Cycle 2p-value: 0.041695% CI: [0.01, 0.5]ANCOVA
Comparison: Parethesia/Dysesthesia Pain Cycle 3p-value: 0.181995% CI: [-0.1, 0.5]ANCOVA
Comparison: Parethesia/Dysesthesia Pain Cycle 4p-value: 0.033195% CI: [0.03, 0.7]ANCOVA
Comparison: Parethesia/Dysesthesia Pain Cycle 5p-value: 0.060895% CI: [-0.02, 0.83]ANCOVA
Comparison: Parethesia/Dysesthesia Pain Cycle 6p-value: 0.280995% CI: [-0.31, 1.03]ANCOVA
Comparison: Parethesia/Dysesthesia Pain Cycle 7p-value: 0.344595% CI: [-0.34, 0.95]ANCOVA
Comparison: Parethesia/Dysesthesia Pain Cycle 8p-value: 0.280695% CI: [-0.44, 1.46]ANCOVA
Comparison: Parethesia/Dysesthesia Pain Cycle 9p-value: 0.521795% CI: [-0.68, 1.33]ANCOVA
Comparison: Parethesia/Dysesthesia Pain LOCF Endpointp-value: 0.362895% CI: [-0.37, 1]ANCOVA
Comparison: Total Score Cycle 2p-value: 0.355795% CI: [0, 0.01]ANCOVA
Comparison: Total Score Cycle 3p-value: 0.282495% CI: [0, 0.01]ANCOVA
Comparison: Total Score Cycle 4p-value: 0.593195% CI: [-0.01, 0.01]ANCOVA
Comparison: Total Score Cycle 5p-value: 0.986595% CI: [-0.01, 0.01]ANCOVA
Comparison: Total Score Cycle 6p-value: 0.985495% CI: [-0.02, 0.02]ANCOVA
Comparison: Total Score Cycle 7p-value: 0.340395% CI: [-0.01, 0.04]ANCOVA
Comparison: Total Score Cycle 8p-value: 0.222695% CI: [-0.01, 0.05]ANCOVA
Comparison: Total Score Cycle 9p-value: 0.969495% CI: [-0.03, 0.03]ANCOVA
Comparison: Total Score LOCF Endpointp-value: 0.895795% CI: [-0.02, 0.02]ANCOVA
Secondary
Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).
Time frame: Baseline to Cycle 9, LOCF cycle endpoint
Population: ITT population, subjects with at lest 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | LOCF endpoint (n=26, 27) | 1.36 score on scale | Standard Error 0.38 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 5 (n=24,22) | 1.54 score on scale | Standard Error 0.48 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 2 (n=26,26) | 0.75 score on scale | Standard Error 0.25 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 3 (n=24,23) | 0.91 score on scale | Standard Error 0.33 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 4 (n=25,23) | 1.01 score on scale | Standard Error 0.37 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 6 (n=21,21) | 0.88 score on scale | Standard Error 0.38 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 7 (n=17,22) | 1.17 score on scale | Standard Error 0.39 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 8 (n=16,19) | 1.33 score on scale | Standard Error 0.4 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 9 (n=16, 18) | 1.24 score on scale | Standard Error 0.44 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 1 (n=25,27) | 0.09 score on scale | Standard Error 0.08 |
| Placebo | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 7 (n=17,22) | 1.17 score on scale | Standard Error 0.34 |
| Placebo | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 4 (n=25,23) | 0.71 score on scale | Standard Error 0.39 |
| Placebo | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 5 (n=24,22) | 0.80 score on scale | Standard Error 0.5 |
| Placebo | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 6 (n=21,21) | 0.93 score on scale | Standard Error 0.38 |
| Placebo | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | LOCF endpoint (n=26, 27) | 1.33 score on scale | Standard Error 0.38 |
| Placebo | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 1 (n=25,27) | 0.13 score on scale | Standard Error 0.07 |
| Placebo | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 9 (n=16, 18) | 1.75 score on scale | Standard Error 0.42 |
| Placebo | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 2 (n=26,26) | 0.38 score on scale | Standard Error 0.25 |
| Placebo | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 8 (n=16,19) | 1.06 score on scale | Standard Error 0.36 |
| Placebo | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 3 (n=24,23) | 0.65 score on scale | Standard Error 0.34 |
Comparison: Cycle 1.p-value: 0.720795% CI: [-0.25, 0.17]ANCOVA
Comparison: Cycle 2.p-value: 0.311195% CI: [-0.36, 1.1]ANCOVA
Comparison: Cycle 3.p-value: 0.592595% CI: [-0.7, 1.22]ANCOVA
Comparison: Cycle 4.p-value: 0.581295% CI: [-0.8, 1.41]ANCOVA
Comparison: Cycle 5.p-value: 0.292595% CI: [-0.67, 2.16]ANCOVA
Comparison: Cycle 6.p-value: 0.927695% CI: [-1.15, 1.05]ANCOVA
Comparison: Cycle 7.p-value: 0.995295% CI: [-1.06, 1.07]ANCOVA
Comparison: Cycle 8.p-value: 0.626595% CI: [-0.85, 1.38]ANCOVA
Comparison: Cycle 9.p-value: 0.420995% CI: [-1.77, 0.76]ANCOVA
Comparison: Last Observation Carried Forward (LOCF)endpoint.p-value: 0.965795% CI: [-1.06, 1.11]ANCOVA
Secondary
Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).
Time frame: Baseline to Cycle 9, LOCF cycle endpoint
Population: ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | LOCF endpoint (n=26, 27) | 0.65 score on scale | Standard Error 0.27 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 6 (n=21,21) | 0.54 score on scale | Standard Error 0.27 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 3 (n=23,23) | 0.47 score on scale | Standard Error 0.24 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 7 (17,22) | 0.92 score on scale | Standard Error 0.31 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 4 (n=25,23) | 0.62 score on scale | Standard Error 0.28 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 8 (n=16,19) | 0.92 score on scale | Standard Error 0.36 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 2 (n=25,26) | 0.29 score on scale | Standard Error 0.15 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 9 (n=16, 18) | 0.86 score on scale | Standard Error 0.41 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 5 (n=24,22) | 0.85 score on scale | Standard Error 0.33 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 1 (n=25,27) | 0.02 score on scale | Standard Error 0.06 |
| Placebo | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | LOCF endpoint (n=26, 27) | 0.78 score on scale | Standard Error 0.27 |
| Placebo | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 1 (n=25,27) | 0.07 score on scale | Standard Error 0.06 |
| Placebo | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 2 (n=25,26) | 0.16 score on scale | Standard Error 0.15 |
| Placebo | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 3 (n=23,23) | 0.26 score on scale | Standard Error 0.24 |
| Placebo | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 4 (n=25,23) | 0.27 score on scale | Standard Error 0.29 |
| Placebo | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 5 (n=24,22) | 0.31 score on scale | Standard Error 0.35 |
| Placebo | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 6 (n=21,21) | 0.58 score on scale | Standard Error 0.27 |
| Placebo | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 7 (17,22) | 0.60 score on scale | Standard Error 0.27 |
| Placebo | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 8 (n=16,19) | 0.60 score on scale | Standard Error 0.33 |
| Placebo | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 9 (n=16, 18) | 0.97 score on scale | Standard Error 0.39 |
Comparison: Cycle 1.p-value: 0.539295% CI: [-0.24, 0.12]ANCOVA
Comparison: Cycle 2.p-value: 0.541295% CI: [-0.3, 0.57]ANCOVA
Comparison: Cycle 3.p-value: 0.535895% CI: [-0.48, 0.9]ANCOVA
Comparison: Cycle 4.p-value: 0.405995% CI: [-0.48, 1.17]ANCOVA
Comparison: Cycle 5.p-value: 0.271295% CI: [-0.44, 1.52]ANCOVA
Comparison: Cycle 6.p-value: 0.918195% CI: [-0.81, 0.73]ANCOVA
Comparison: Cycle 7.p-value: 0.435795% CI: [-0.52, 1.17]ANCOVA
p-value: 0.510395% CI: [-0.67, 1.33]ANCOVA
Comparison: Cycle 9.p-value: 0.849995% CI: [-1.29, 1.07]ANCOVA
Comparison: LOCF endpoint.p-value: 0.735995% CI: [-0.9, 0.64]ANCOVA
Secondary
Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).
Time frame: Baseline to Cycle 9
Population: Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 8 (n=16, 19) | 0.83 score on scale | Standard Error 0.29 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 4 (n=25, 23) | 0.64 score on scale | Standard Error 0.21 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 5 (n=24, 22) | 1.03 score on scale | Standard Error 0.33 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 7 (n=17, 22) | 0.93 score on scale | Standard Error 0.3 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 9 (n=16, 18) | 0.92 score on scale | Standard Error 0.36 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 1 (n=25, 27) | 0.03 score on scale | Standard Error 0.06 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 2 (n=26, 26) | 0.35 score on scale | Standard Error 0.16 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 6 (n=21, 21) | 0.74 score on scale | Standard Error 0.28 |
| Pregabalin | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 3 (n=24, 23) | 0.53 score on scale | Standard Error 0.21 |
| Placebo | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 6 (n=21, 21) | 0.64 score on scale | Standard Error 0.28 |
| Placebo | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 3 (n=24, 23) | 0.37 score on scale | Standard Error 0.21 |
| Placebo | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 9 (n=16, 18) | 1.65 score on scale | Standard Error 0.34 |
| Placebo | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 4 (n=25, 23) | 0.40 score on scale | Standard Error 0.22 |
| Placebo | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 2 (n=26, 26) | 0.22 score on scale | Standard Error 0.16 |
| Placebo | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 5 (n=24, 22) | 0.53 score on scale | Standard Error 0.35 |
| Placebo | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 1 (n=25, 27) | 0.13 score on scale | Standard Error 0.05 |
| Placebo | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 7 (n=17, 22) | 0.96 score on scale | Standard Error 0.26 |
| Placebo | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Cycle 8 (n=16, 19) | 1.03 score on scale | Standard Error 0.27 |
Comparison: Cycle 1. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.p-value: 0.2536ANCOVA
Comparison: Cycle 2. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.p-value: 0.5757ANCOVA
Comparison: Cycle 3. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.p-value: 0.6065ANCOVA
Comparison: Cycle 4. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.p-value: 0.4301ANCOVA
Comparison: Cycle 5. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.p-value: 0.3125ANCOVA
Comparison: Cycle 6.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.p-value: 0.8169ANCOVA
Comparison: Cycle 7. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.p-value: 0.9359ANCOVA
Comparison: Cycle 8. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.p-value: 0.6233ANCOVA
Comparison: Cycle 9.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.p-value: 0.1569ANCOVA
Secondary
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: \>=1: mild symptoms to \>=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime.
Time frame: Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint
Population: ITT population, subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia LOCF endpoint (n=30,29 (>or=4) | 2 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia Cycle 9 (n=19,19) (>or=1) | 10 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia LOCF endpoint (n=30,29) (>or=1) | 11 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia Cycle 9 (n=19,19) (>or=2) | 5 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia LOCF endpoint (n=30,29) (>or=2) | 6 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia LOCF endpoint (n=30,29) (>or=3) | 4 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain Cycle 9 (n=19,19) (>or=1) | 6 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain LOCF endpoint (n=30,29;) (>or=1) | 6 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia Cycle 9 (n=19,19) (>or=1) | 7 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia LOCF endpoint (n=30,29) (>or=1) | 8 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia Cycle 9 (n=19,19) (>or=2) | 4 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia LOCF endpoint (n=30,29) (>or=2) | 5 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia Cycle 9 (n=19,19) (>or=3) | 2 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia LOCF endpoint (n=30,29) (>or=3) | 3 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia Cycle 9 (n=19,19) (>or=4) | 1 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia Cycle 9 (n=19,19) (>or=3) | 3 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia Cycle 9 (n=19,19) (>or=4) | 1 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia LOCF endpoint (n=30,29) (>or=4) | 2 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain Cycle 9 (n=19,19) (>or=2) | 2 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain LOCF endpoint (n=30,29) (>or=2) | 2 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain Cycle 9 (n=19,19) (>or=3) | 1 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain LOCF endpoint (n=30,29) (>or=3) | 1 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain Cycle 9 (n=19,19) (>or=4) | 0 participants |
| Pregabalin | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain LOCF endpoint (n=30,29) (>or=4) | 0 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain Cycle 9 (n=19,19) (>or=1) | 2 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia LOCF endpoint (n=30,29) (>or=4) | 1 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia Cycle 9 (n=19,19) (>or=3) | 1 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia Cycle 9 (n=19,19) (>or=1) | 4 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain Cycle 9 (n=19,19) (>or=4) | 1 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia LOCF endpoint (n=30,29) (>or=1) | 5 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia LOCF endpoint (n=30,29) (>or=3) | 1 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain Cycle 9 (n=19,19) (>or=2) | 1 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia LOCF endpoint (n=30,29) (>or=2) | 4 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia Cycle 9 (n=19,19) (>or=4) | 1 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia LOCF endpoint (n=30,29) (>or=3) | 2 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia LOCF endpoint (n=30,29 (>or=4) | 2 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia Cycle 9 (n=19,19) (>or=2) | 3 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain LOCF endpoint (n=30,29) (>or=3) | 2 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain LOCF endpoint (n=30,29;) (>or=1) | 3 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain Cycle 9 (n=19,19) (>or=3) | 1 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia Cycle 9 (n=19,19) (>or=3) | 1 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia Cycle 9 (n=19,19) (>or=1) | 6 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain LOCF endpoint (n=30,29) (>or=2) | 2 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia LOCF endpoint (n=30,29) (>or=1) | 7 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Dysesthesia Cycle 9 (n=19,19) (>or=4) | 1 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia Cycle 9 (n=19,19) (>or=2) | 3 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Pain LOCF endpoint (n=30,29) (>or=4) | 2 participants |
| Placebo | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Paresthesia LOCF endpoint (n=30,29) (>or=2) | 3 participants |