Trial Outcomes & Findings for Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer (NCT NCT00380874)
NCT ID: NCT00380874
Last Updated: 2021-02-11
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)
Results posted on
2021-02-11
Participant Flow
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.
Participant milestones
| Measure |
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).
|
Placebo
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
29
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
Reasons for withdrawal
| Measure |
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).
|
Placebo
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
7
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Not related to study drug
|
3
|
2
|
Baseline Characteristics
Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Pregabalin
n=32 Participants
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).
|
Placebo
n=29 Participants
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
Pregabalin
n=32 Participants
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).
|
Placebo
n=29 Participants
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
|---|---|---|
|
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
|
1.27 score on scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline to Cycle 9Population: 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.
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).
Outcome measures
| Measure |
Pregabalin
n=32 Participants
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).
|
Placebo
n=29 Participants
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
|---|---|---|
|
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
|
1.65 score on scale
Standard Error 0.34
|
|
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
|
0.13 score on scale
Standard Error 0.05
|
|
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
|
0.22 score on scale
Standard Error 0.16
|
|
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
|
0.37 score on scale
Standard Error 0.21
|
|
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
|
0.40 score on scale
Standard Error 0.22
|
|
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
|
0.53 score on scale
Standard Error 0.35
|
|
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
|
0.64 score on scale
Standard Error 0.28
|
|
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 0.30
|
0.96 score on scale
Standard Error 0.26
|
|
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
|
1.03 score on scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline to Cycle 9, LOCF cycle endpointPopulation: ITT population, subjects with at lest 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
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).
Outcome measures
| Measure |
Pregabalin
n=32 Participants
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).
|
Placebo
n=29 Participants
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
|---|---|---|
|
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
|
0.13 score on scale
Standard Error 0.07
|
|
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
|
0.38 score on scale
Standard Error 0.25
|
|
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
|
0.65 score on scale
Standard Error 0.34
|
|
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
|
0.71 score on scale
Standard Error 0.39
|
|
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
|
0.80 score on scale
Standard Error 0.50
|
|
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
|
0.93 score on scale
Standard Error 0.38
|
|
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
|
1.17 score on scale
Standard Error 0.34
|
|
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 0.40
|
1.06 score on scale
Standard Error 0.36
|
|
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
|
1.75 score on scale
Standard Error 0.42
|
|
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
|
1.33 score on scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline to Cycle 9, LOCF cycle endpointPopulation: ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
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).
Outcome measures
| Measure |
Pregabalin
n=32 Participants
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).
|
Placebo
n=29 Participants
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
|---|---|---|
|
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
|
0.07 score on scale
Standard Error 0.06
|
|
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
|
0.16 score on scale
Standard Error 0.15
|
|
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
|
0.26 score on scale
Standard Error 0.24
|
|
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
|
0.27 score on scale
Standard Error 0.29
|
|
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
|
0.31 score on scale
Standard Error 0.35
|
|
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
|
0.58 score on scale
Standard Error 0.27
|
|
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
|
0.60 score on scale
Standard Error 0.27
|
|
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
|
0.60 score on scale
Standard Error 0.33
|
|
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
|
0.97 score on scale
Standard Error 0.39
|
|
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
|
0.78 score on scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpointPopulation: ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
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.
Outcome measures
| Measure |
Pregabalin
n=32 Participants
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).
|
Placebo
n=29 Participants
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
|---|---|---|
|
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
|
0.13 score on scale
Standard Error 0.07
|
|
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
|
0.017 score on scale
Standard Error 0.07
|
|
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
|
0.21 score on scale
Standard Error 0.09
|
|
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
|
0.35 score on scale
Standard Error 0.16
|
|
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
|
0.32 score on scale
Standard Error 0.23
|
|
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
|
0.38 score on scale
Standard Error 0.16
|
|
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 0.10
|
0.20 score on scale
Standard Error 0.11
|
|
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
|
0.04 score on scale
Standard Error 0.06
|
|
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
|
0.07 score on scale
Standard Error 0.13
|
|
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
|
0.28 score on scale
Standard Error 0.09
|
|
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
|
0.29 score on scale
Standard Error 0.14
|
|
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
|
0.66 score on scale
Standard Error 0.28
|
|
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
|
0.40 score on scale
Standard Error 0.26
|
|
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
|
0.36 score on scale
Standard Error 0.35
|
|
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
|
0.59 score on scale
Standard Error 0.26
|
|
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
|
0.43 score on scale
Standard Error 0.19
|
|
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
|
-0.00 score on scale
Standard Error 0.09
|
|
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 0.10
|
0.14 score on scale
Standard Error 0.11
|
|
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
|
0.06 score on scale
Standard Error 0.12
|
|
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
|
0.20 score on scale
Standard Error 0.15
|
|
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
|
0.32 score on scale
Standard Error 0.24
|
|
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
|
0.48 score on scale
Standard Error 0.22
|
|
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
|
0.58 score on scale
Standard Error 0.32
|
|
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
|
0.85 score on scale
Standard Error 0.34
|
|
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
|
0.52 score on scale
Standard Error 0.25
|
|
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 0.00
|
0.00 score on scale
Standard Error 0.00
|
|
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 0.00
|
0.00 score on scale
Standard Error 0.00
|
|
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 0.00
|
0.01 score on scale
Standard Error 0.00
|
|
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 0.00
|
0.01 score on scale
Standard Error 0.00
|
|
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
|
0.02 score on scale
Standard Error 0.01
|
|
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
|
0.02 score on scale
Standard Error 0.01
|
|
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
|
0.02 score on scale
Standard Error 0.01
|
|
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
|
0.03 score on scale
Standard Error 0.01
|
|
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
|
0.02 score on scale
Standard Error 0.01
|
|
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
|
0.19 score on scale
Standard Error 0.08
|
|
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
|
-0.02 score on scale
Standard Error 0.06
|
|
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
|
0.15 score on scale
Standard Error 0.10
|
|
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
|
0.14 score on scale
Standard Error 0.12
|
|
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
|
0.40 score on scale
Standard Error 0.24
|
|
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
|
0.23 score on scale
Standard Error 0.21
|
|
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
|
0.59 score on scale
Standard Error 0.27
|
|
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
|
0.35 score on scale
Standard Error 019
|
|
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
|
0.05 score on scale
Standard Error 0.04
|
|
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
|
0.01 score on scale
Standard Error 0.03
|
|
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
|
0.20 score on scale
Standard Error 0.09
|
|
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
|
0.06 score on scale
Standard Error 0.04
|
|
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
|
0.09 score on scale
Standard Error 0.05
|
|
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
|
0.30 score on scale
Standard Error 0.17
|
|
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
|
0.12 score on scale
Standard Error 0.15
|
|
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
|
0.14 score on scale
Standard Error 0.08
|
|
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
|
0.08 score on scale
Standard Error 0.06
|
|
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
|
0.02 score on scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpointPopulation: ITT population, subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
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.
Outcome measures
| Measure |
Pregabalin
n=32 Participants
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).
|
Placebo
n=29 Participants
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
|---|---|---|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Paresthesia Cycle 9 (n=19,19) (>or=1)
|
7 participants
|
6 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Paresthesia LOCF endpoint (n=30,29) (>or=1)
|
8 participants
|
7 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Paresthesia Cycle 9 (n=19,19) (>or=2)
|
4 participants
|
3 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Paresthesia LOCF endpoint (n=30,29) (>or=2)
|
5 participants
|
3 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Paresthesia Cycle 9 (n=19,19) (>or=3)
|
2 participants
|
1 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Paresthesia LOCF endpoint (n=30,29) (>or=3)
|
3 participants
|
1 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Paresthesia Cycle 9 (n=19,19) (>or=4)
|
1 participants
|
1 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Paresthesia LOCF endpoint (n=30,29) (>or=4)
|
2 participants
|
1 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Dysesthesia Cycle 9 (n=19,19) (>or=1)
|
10 participants
|
4 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Dysesthesia LOCF endpoint (n=30,29) (>or=1)
|
11 participants
|
5 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Dysesthesia Cycle 9 (n=19,19) (>or=2)
|
5 participants
|
3 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Dysesthesia LOCF endpoint (n=30,29) (>or=2)
|
6 participants
|
4 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Dysesthesia Cycle 9 (n=19,19) (>or=3)
|
3 participants
|
1 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Dysesthesia LOCF endpoint (n=30,29) (>or=3)
|
4 participants
|
2 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Dysesthesia Cycle 9 (n=19,19) (>or=4)
|
1 participants
|
1 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Dysesthesia LOCF endpoint (n=30,29 (>or=4)
|
2 participants
|
2 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Pain Cycle 9 (n=19,19) (>or=1)
|
6 participants
|
2 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Pain LOCF endpoint (n=30,29;) (>or=1)
|
6 participants
|
3 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Pain Cycle 9 (n=19,19) (>or=2)
|
2 participants
|
1 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Pain LOCF endpoint (n=30,29) (>or=2)
|
2 participants
|
2 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Pain Cycle 9 (n=19,19) (>or=3)
|
1 participants
|
1 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Pain LOCF endpoint (n=30,29) (>or=3)
|
1 participants
|
2 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Pain Cycle 9 (n=19,19) (>or=4)
|
0 participants
|
1 participants
|
|
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Pain LOCF endpoint (n=30,29) (>or=4)
|
0 participants
|
2 participants
|
Adverse Events
Pregabalin
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=32 participants at risk
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).
|
Placebo
n=29 participants at risk
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/32
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/32
|
3.4%
1/29
|
|
Cardiac disorders
Arrhythmia
|
3.1%
1/32
|
0.00%
0/29
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/32
|
3.4%
1/29
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/32
|
3.4%
1/29
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32
|
3.4%
1/29
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.1%
1/32
|
0.00%
0/29
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32
|
0.00%
0/29
|
|
General disorders
Disease progression
|
0.00%
0/32
|
3.4%
1/29
|
|
General disorders
Extravasation
|
3.1%
1/32
|
0.00%
0/29
|
|
General disorders
Pyrexia
|
3.1%
1/32
|
3.4%
1/29
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/32
|
3.4%
1/29
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32
|
3.4%
1/29
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/32
|
3.4%
1/29
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal carcinoma
|
0.00%
0/32
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
1/32
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.1%
1/32
|
0.00%
0/29
|
|
Vascular disorders
Shock
|
0.00%
0/32
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Anorexia
|
3.1%
1/32
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
2/32
|
0.00%
0/29
|
Other adverse events
| Measure |
Pregabalin
n=32 participants at risk
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).
|
Placebo
n=29 participants at risk
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
28.1%
9/32
|
34.5%
10/29
|
|
Blood and lymphatic system disorders
Anaemia
|
9.4%
3/32
|
6.9%
2/29
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.6%
5/32
|
24.1%
7/29
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.9%
7/32
|
27.6%
8/29
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/32
|
3.4%
1/29
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/32
|
3.4%
1/29
|
|
Ear and labyrinth disorders
Vertigo
|
3.1%
1/32
|
3.4%
1/29
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/32
|
3.4%
1/29
|
|
Eye disorders
Eye irritation
|
3.1%
1/32
|
0.00%
0/29
|
|
Eye disorders
Lacrimation increased
|
3.1%
1/32
|
0.00%
0/29
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.1%
1/32
|
0.00%
0/29
|
|
Gastrointestinal disorders
Abdominal distension
|
3.1%
1/32
|
3.4%
1/29
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32
|
17.2%
5/29
|
|
Gastrointestinal disorders
Constipation
|
25.0%
8/32
|
27.6%
8/29
|
|
Gastrointestinal disorders
Diarrhoea
|
28.1%
9/32
|
27.6%
8/29
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
1/32
|
0.00%
0/29
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/32
|
3.4%
1/29
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
1/32
|
6.9%
2/29
|
|
Gastrointestinal disorders
Gingival pain
|
3.1%
1/32
|
3.4%
1/29
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/32
|
3.4%
1/29
|
|
Gastrointestinal disorders
Nausea
|
50.0%
16/32
|
44.8%
13/29
|
|
Gastrointestinal disorders
Oesophageal pain
|
3.1%
1/32
|
0.00%
0/29
|
|
Gastrointestinal disorders
Paraesthesia oral
|
3.1%
1/32
|
0.00%
0/29
|
|
Gastrointestinal disorders
Rectal tenesmus
|
3.1%
1/32
|
3.4%
1/29
|
|
Eye disorders
Stomatitis
|
9.4%
3/32
|
17.2%
5/29
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/32
|
3.4%
1/29
|
|
Gastrointestinal disorders
Vomiting
|
15.6%
5/32
|
34.5%
10/29
|
|
General disorders
Asthenia
|
21.9%
7/32
|
13.8%
4/29
|
|
General disorders
Chest pain
|
3.1%
1/32
|
0.00%
0/29
|
|
General disorders
Chills
|
12.5%
4/32
|
6.9%
2/29
|
|
General disorders
Fatigue
|
25.0%
8/32
|
24.1%
7/29
|
|
General disorders
Feeling cold
|
3.1%
1/32
|
3.4%
1/29
|
|
General disorders
Implant site pain
|
3.1%
1/32
|
3.4%
1/29
|
|
General disorders
Mucosal inflammation
|
18.8%
6/32
|
17.2%
5/29
|
|
General disorders
Oedema peripheral
|
3.1%
1/32
|
0.00%
0/29
|
|
General disorders
Pain
|
0.00%
0/32
|
3.4%
1/29
|
|
General disorders
Peripheral coldness
|
0.00%
0/32
|
6.9%
2/29
|
|
General disorders
Pyrexia
|
25.0%
8/32
|
13.8%
4/29
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.1%
1/32
|
6.9%
2/29
|
|
Immune system disorders
Allergy to arthropod sting
|
3.1%
1/32
|
0.00%
0/29
|
|
Immune system disorders
Drug hypersensitivity
|
6.2%
2/32
|
10.3%
3/29
|
|
Immune system disorders
Hypersensitivity
|
3.1%
1/32
|
3.4%
1/29
|
|
Infections and infestations
Cystitis
|
0.00%
0/32
|
3.4%
1/29
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/32
|
3.4%
1/29
|
|
Infections and infestations
Influenza
|
3.1%
1/32
|
0.00%
0/29
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
2/32
|
13.8%
4/29
|
|
Infections and infestations
Otitis media
|
0.00%
0/32
|
3.4%
1/29
|
|
Infections and infestations
Respiratory tract infection
|
3.1%
1/32
|
0.00%
0/29
|
|
Infections and infestations
Rhinitis
|
3.1%
1/32
|
0.00%
0/29
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
3.1%
1/32
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.1%
1/32
|
0.00%
0/29
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32
|
3.4%
1/29
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/32
|
3.4%
1/29
|
|
Investigations
Blood creatine increased
|
3.1%
1/32
|
0.00%
0/29
|
|
Investigations
Body temperature increased
|
3.1%
1/32
|
0.00%
0/29
|
|
Investigations
Platelet count
|
3.1%
1/32
|
3.4%
1/29
|
|
Investigations
Weight decreased
|
3.1%
1/32
|
3.4%
1/29
|
|
Investigations
Weight increased
|
0.00%
0/32
|
10.3%
3/29
|
|
Metabolism and nutrition disorders
Anorexia
|
40.6%
13/32
|
37.9%
11/29
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.1%
1/32
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.1%
1/32
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.1%
1/32
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/32
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.1%
1/32
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
2/32
|
6.9%
2/29
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/32
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Neckpain
|
3.1%
1/32
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
3.1%
1/32
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/32
|
3.4%
1/29
|
|
Nervous system disorders
Amnesia
|
3.1%
1/32
|
0.00%
0/29
|
|
Nervous system disorders
Dizziness
|
21.9%
7/32
|
13.8%
4/29
|
|
Nervous system disorders
Dysaethesia
|
3.1%
1/32
|
0.00%
0/29
|
|
Nervous system disorders
Headache
|
15.6%
5/32
|
6.9%
2/29
|
|
Nervous system disorders
Hyperaesthesia
|
3.1%
1/32
|
3.4%
1/29
|
|
Nervous system disorders
Neuralgia
|
3.1%
1/32
|
0.00%
0/29
|
|
Nervous system disorders
Neuropathy peripheral
|
21.9%
7/32
|
24.1%
7/29
|
|
Nervous system disorders
Paraesthesia
|
3.1%
1/32
|
13.8%
4/29
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.4%
3/32
|
10.3%
3/29
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/32
|
6.9%
2/29
|
|
Nervous system disorders
Syncope vasovagal
|
3.1%
1/32
|
0.00%
0/29
|
|
Psychiatric disorders
Depression
|
3.1%
1/32
|
0.00%
0/29
|
|
Psychiatric disorders
Insomnia
|
6.2%
2/32
|
17.2%
5/29
|
|
Renal and urinary disorders
Urinary incontinence
|
3.1%
1/32
|
0.00%
0/29
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/32
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
2/32
|
13.8%
4/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
2/32
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
1/32
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.1%
1/32
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/32
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
3.1%
1/32
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.1%
1/32
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.1%
1/32
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/32
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.1%
1/32
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.8%
6/32
|
13.8%
4/29
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/32
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/32
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/32
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
9.4%
3/32
|
13.8%
4/29
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32
|
10.3%
3/29
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
2/32
|
13.8%
4/29
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
3.1%
1/32
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/32
|
6.9%
2/29
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/32
|
3.4%
1/29
|
|
Vascular disorders
Flushing
|
3.1%
1/32
|
0.00%
0/29
|
|
Vascular disorders
Hypertension
|
0.00%
0/32
|
3.4%
1/29
|
|
Vascular disorders
Phlebitis
|
6.2%
2/32
|
3.4%
1/29
|
|
Vascular disorders
Subclavian vein thrombosis
|
3.1%
1/32
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
1/32
|
6.9%
2/29
|
|
Nervous system disorders
hypoaesthesia
|
6.2%
2/32
|
6.9%
2/29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER