Trial Outcomes & Findings for Neuropathic Pain in Pregnancy (NCT NCT02608463)
NCT ID: NCT02608463
Last Updated: 2021-06-23
Results Overview
100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state. The total score ranges from 0-100 with higher numbers indicating worse outcomes. The VAS will be administered at every subject visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Baseline and end of study participation, an average of 194 days
Results posted on
2021-06-23
Participant Flow
Participant milestones
| Measure |
Part A: Neuropathic Pain Group
≥13 on the painDETECT Questionnaire (PDQ) 10 subjects
|
Part A: Non-Neuropathic Pain Group
≥1 and ≤12 on the PDQ 5 subjects
|
Part A: Controls
Patients without neuropathic pain receiving care as usual.
|
Part B Participants
No participants were ever enrolled in Part B, so this group has been dropped from all future sections.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
0
|
0
|
|
Overall Study
COMPLETED
|
10
|
5
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuropathic Pain in Pregnancy
Baseline characteristics by cohort
| Measure |
Neuropathic Pain Group
n=10 Participants
≥13 on the painDETECT Questionnaire (PDQ)
|
Non-Neuropathic Pain Group
n=5 Participants
score of ≥1 or ≤12 on the PDQ
|
Controls
Patients without neuropathic pain receiving care as usual.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
29.4 years
n=5 Participants
|
29.4 years
n=7 Participants
|
—
|
29.4 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
—
|
15 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of study participation, an average of 194 daysPopulation: No subjects were ever assigned to the control group, so no stats were performed on this group
100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state. The total score ranges from 0-100 with higher numbers indicating worse outcomes. The VAS will be administered at every subject visit.
Outcome measures
| Measure |
Neuropathic Pain Group
n=10 Participants
≥13 on the painDETECT Questionnaire (PDQ) 10 subjects
|
Non-Neuropathic Pain Group
n=5 Participants
≥1 and ≤12 on the PDQ 5 subjects
|
Control
Patients without neuropathic pain receiving care as usual. Due to n=0, no statistical analysis was completed.
|
|---|---|---|---|
|
Change From Baseline Visual Analogue Scale for Pain
|
-0.57 score on a scale
Interval -18.26 to 17.12
|
-14.4 score on a scale
Interval -47.02 to 18.22
|
—
|
Adverse Events
Neuropathic Pain Group
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Non-Neuropathic Pain Group
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neuropathic Pain Group
n=10 participants at risk
score of ≥13 on the PDQ
Total Serious Adverse Events: 6 Number of Participants Affected by Serious Adverse Events: 3
Total Adverse Events: 62 Number of Participants Affected by Adverse Events: 8
|
Non-Neuropathic Pain Group
n=5 participants at risk
score of ≥ 1 or ≤ 12 on the PDQ
Total Serious Adverse Events: 40 Number of Participants Affected by Serious Adverse Events: 3
Total Adverse Events: 39 Number of Participants Affected by Adverse Events: 5
|
Controls
score of 0 on the PDQ
Total Serious Adverse Events: 0 Number of Participants Affected by Serious Adverse Events: 0
Total Adverse Events: 0 Number of Participants Affected by Adverse Events: 0
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
60.0%
3/5 • Number of events 3 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Cardiac disorders
Patent Ductus Arteriosus
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Severe Retro-Micrognathia with Critical Airway
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Congenital, familial and genetic disorders
Microtia
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Congenital, familial and genetic disorders
Microstomia
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Vertebral Anomalies
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Infections and infestations
Infection of Tracheotomy
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Infections and infestations
Acinetobacter Infection of GT site
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Congenital, familial and genetic disorders
Cleft Palate
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Congenital, familial and genetic disorders
Bilateral superior vena cava without bridging vein
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Shortened Femurs
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Congenital, familial and genetic disorders
Bilateral Club Feet
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Teratologic Hips
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Congenital, familial and genetic disorders
Glossoptosis
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Social circumstances
Medical neglect of child by caregiver
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Cardiac disorders
Cardiopulmonary arrest with successful resuscitation
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
40.0%
2/5 • Number of events 2 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Infections and infestations
Moraxella catarrhalis & HFLU Pneumonia
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Blood and lymphatic system disorders
Hypochloremia
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Psychiatric disorders
Hyperactive Delirium
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Infections and infestations
Rhinovirus Bronchitis
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Reproductive system and breast disorders
Preeclampsia
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Reproductive system and breast disorders
Pre-Term Labor
|
10.0%
1/10 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Infections and infestations
Incision Infection
|
10.0%
1/10 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Reproductive system and breast disorders
Hellp Syndrome (Atypical)
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Social circumstances
Neonatal Abstinence Syndrome
|
10.0%
1/10 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
40.0%
2/5 • Number of events 2 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Infections and infestations
Meconium Aspiration
|
10.0%
1/10 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Respiratory, thoracic and mediastinal disorders
Transient Trachypnea
|
10.0%
1/10 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Metabolism and nutrition disorders
Metabolic ketoacidosis
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
40.0%
2/5 • Number of events 2 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Nervous system disorders
seizure-like activity
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Pregnancy, puerperium and perinatal conditions
Premature Rupture of Membranes
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Pregnancy, puerperium and perinatal conditions
Preterm Delivery
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Pregnancy, puerperium and perinatal conditions
Patent foramen ovale
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Respiratory, thoracic and mediastinal disorders
Severe Retro-Micrognathia with critical airway
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
Other adverse events
| Measure |
Neuropathic Pain Group
n=10 participants at risk
score of ≥13 on the PDQ
Total Serious Adverse Events: 6 Number of Participants Affected by Serious Adverse Events: 3
Total Adverse Events: 62 Number of Participants Affected by Adverse Events: 8
|
Non-Neuropathic Pain Group
n=5 participants at risk
score of ≥ 1 or ≤ 12 on the PDQ
Total Serious Adverse Events: 40 Number of Participants Affected by Serious Adverse Events: 3
Total Adverse Events: 39 Number of Participants Affected by Adverse Events: 5
|
Controls
score of 0 on the PDQ
Total Serious Adverse Events: 0 Number of Participants Affected by Serious Adverse Events: 0
Total Adverse Events: 0 Number of Participants Affected by Adverse Events: 0
|
|---|---|---|---|
|
Nervous system disorders
Pain Increase
|
80.0%
8/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
60.0%
3/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Nervous system disorders
Headaches
|
30.0%
3/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
40.0%
2/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Nervous system disorders
Anesthesia Difficulty
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Psychiatric disorders
Depressed Mood
|
40.0%
4/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
40.0%
2/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
20.0%
2/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Blood and lymphatic system disorders
Dry Mouth
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Metabolism and nutrition disorders
Dizzy Spells
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Eye disorders
Vision Changes
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
40.0%
2/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Psychiatric disorders
Insomnia
|
30.0%
3/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
40.0%
2/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Psychiatric disorders
Irritability
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Reproductive system and breast disorders
Braxton Hicks Contractions
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Carpel Tunnel
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Psychiatric disorders
Drowsiness or sedation
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
20.0%
2/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Blood and lymphatic system disorders
Bilateral Feet Edema
|
30.0%
3/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Psychiatric disorders
Fatigue
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Psychiatric disorders
Postpartum Depression
|
20.0%
2/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Heartburn
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
General disorders
Lip Tie
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Right Ankle Pain
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Immune system disorders
Allergies
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Abdominal Cramps
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Reproductive system and breast disorders
Bacterial Vaginosis
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Reproductive system and breast disorders
Urinary Tract Infection
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Reproductive system and breast disorders
Yeast Infection
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Injury, poisoning and procedural complications
Skin Burning
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Reproductive system and breast disorders
Mastitis
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Hemorrhoid
|
20.0%
2/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Nervous system disorders
Sciatica
|
20.0%
2/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Tooth pain or Absess
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
20.0%
2/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Weight Loss
|
10.0%
1/10 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Weight Gain
|
10.0%
1/10 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Cardiac disorders
Hypertension
|
20.0%
2/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Nervous system disorders
Migraine
|
10.0%
1/10 • Number of events 1 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Renal and urinary disorders
Flank Pain
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Skin and subcutaneous tissue disorders
Bilateral Hand Edema
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Nervous system disorders
Numbness/tingling of bilateral hands
|
10.0%
1/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
0.00%
0/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Reproductive system and breast disorders
Preterm Labor
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Skin and subcutaneous tissue disorders
Diaper Dermatitis
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Renal and urinary disorders
Low Lying Kidneys
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
|
Gastrointestinal disorders
Cellulitis at gastrostomy tube site
|
0.00%
0/10 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
20.0%
1/5 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
—
0/0 • Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
|
Additional Information
Dr. Shona Ray-Griffith
University of Arkansas for Medical Sciences
Phone: 501-526-8428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place