Trial Outcomes & Findings for Intranasal (NAS) Ketamine for Cancer Pain (NCT NCT03146806)
NCT ID: NCT03146806
Last Updated: 2021-09-09
Results Overview
Blood samples were obtained at the study visits where ketamine was administered to measure the bioavailability (a pharmacokinetic characteristic) of intranasal and intravenous ketamine. Bioavailability is assessed as nanograms per milliliter (ng/mL) of ketamine circulating in blood. Each study participant received each dose of ketamine during separate study visits. Samples were obtained prior to ketamine administration, and at 2, 30, 60 and 240 minutes after medication administration, during study visits 1 through 4. The baseline sample was not collected at the first study visit as assessing prior intake of ketamine was not necessary.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Baseline, Minutes 2, 30, 60, and 240 during Study Visits 1 through 4, up to 4 weeks
Results posted on
2021-09-09
Participant Flow
Participants will be recruited from the supportive oncology clinic, oncology clinics, and pain clinics at Emory University in Atlanta, Georgia. Participant enrollment began July 25, 2017 and all follow up was complete by April 22, 2020.
Participant milestones
| Measure |
Ketamine Treatment
On the first study visit, 10mg of intranasal ketamine was given to make sure that the study patients could tolerate a small dose of intranasal ketamine. On the second visit, 10 mg of intravenous (IV) ketamine was given to compare the two routes of ketamine administration, with patients serving as their own controls. On the third and fourth visit, higher doses of intranasal ketamine, 30 mg and 50 mg respectively, were given, if the patients did not have severe adverse events with the smaller dosage. Participants returned for a fifth visit, 24 hours after Visit 4, to provide a blood sample and complete questionnaires.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal (NAS) Ketamine for Cancer Pain
Baseline characteristics by cohort
| Measure |
Intranasal Ketamine Treatment
n=10 Participants
Study participants receiving three different doses of intranasal ketamine and one dose of IV ketamine, at four different study visits, for treatment of cancer pain.
|
|---|---|
|
Age, Continuous
|
49.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
|
Cancer Type
Breast
|
4 Participants
n=99 Participants
|
|
Cancer Type
Bone
|
2 Participants
n=99 Participants
|
|
Cancer Type
Lung
|
1 Participants
n=99 Participants
|
|
Cancer Type
Colon
|
1 Participants
n=99 Participants
|
|
Cancer Type
Larynx
|
1 Participants
n=99 Participants
|
|
Cancer Type
Multiple myeloma
|
1 Participants
n=99 Participants
|
|
Pain Type
Nociceptive
|
5 Participants
n=99 Participants
|
|
Pain Type
Neuropathic
|
0 Participants
n=99 Participants
|
|
Pain Type
Mixed nociceptive and neuropathic pain
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Minutes 2, 30, 60, and 240 during Study Visits 1 through 4, up to 4 weeksPopulation: The baseline measurement was not collected during the visit where 10 mg of intranasal ketamine was administered. This analysis includes participants with viable samples. Some samples were not able to be reliably analyzed for this outcome.
Blood samples were obtained at the study visits where ketamine was administered to measure the bioavailability (a pharmacokinetic characteristic) of intranasal and intravenous ketamine. Bioavailability is assessed as nanograms per milliliter (ng/mL) of ketamine circulating in blood. Each study participant received each dose of ketamine during separate study visits. Samples were obtained prior to ketamine administration, and at 2, 30, 60 and 240 minutes after medication administration, during study visits 1 through 4. The baseline sample was not collected at the first study visit as assessing prior intake of ketamine was not necessary.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=7 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=9 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Bioavailability of Ketamine
240 minutes post-ketamine administration
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Bioavailability of Ketamine
Baseline
|
—
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Bioavailability of Ketamine
2 minutes post-ketamine administration
|
13.4 ng/mL
Standard Deviation 1.65
|
296.4 ng/mL
Standard Deviation 1.71
|
23.7 ng/mL
Standard Deviation 2.98
|
33.7 ng/mL
Standard Deviation 3.86
|
—
|
|
Bioavailability of Ketamine
30 minutes post-ketamine administration
|
20.3 ng/mL
Standard Deviation 2.01
|
35.0 ng/mL
Standard Deviation 1.35
|
48.6 ng/mL
Standard Deviation 1.67
|
51.0 ng/mL
Standard Deviation 1.75
|
—
|
|
Bioavailability of Ketamine
60 minutes post-ketamine administration
|
11.7 ng/mL
Standard Deviation 1.38
|
16.4 ng/mL
Standard Deviation 1.70
|
26.5 ng/mL
Standard Deviation 2.1
|
55.8 ng/mL
Standard Deviation 2.12
|
—
|
PRIMARY outcome
Timeframe: Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 weeksPopulation: This analysis includes participants with viable samples. Some samples were not able to be reliably analyzed for this outcome.
Blood samples were obtained at the study visits where ketamine was administered to measure the peak concentration (Cmax) of intranasal and intravenous ketamine. Peak concentration is assessed as the maximum ng/mL of ketamine circulating in blood. Each study participant received each dose of ketamine during separate study visits. Samples were obtained at 2, 30, 60 and 240 minutes after medication administration.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=7 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=9 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Peak Concentration (Cmax) of Ketamine
|
22.9 ng/ml
Standard Deviation 1.97
|
296 ng/ml
Standard Deviation 1.71
|
60.8 ng/ml
Standard Deviation 1.90
|
77.6 ng/ml
Standard Deviation 2.29
|
—
|
PRIMARY outcome
Timeframe: Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 WeeksPopulation: This analysis includes participants with viable samples. Some samples were not able to be reliably analyzed for this outcome.
Blood samples were obtained at the study visits where ketamine was administered to measure the elimination (a pharmacokinetic characteristic) of intranasal and intravenous ketamine. Elimination of the drug disappearing from the body is assessed as the area under the curve (AUC). Each study participant received each dose of ketamine during separate study visits. Samples were obtained at 2, 30, 60 and 240 minutes after medication administration. Each subject did not have quantitative levels at all time points. There were not enough data to construct a curve for each participant and therefore calculate an AUC. Data from all participants were naively pooled to calculate one AUC for the entire population (i.e., across all participants' data).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=7 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=9 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Area Under the Curve of Ketamine
|
19 micrograms•hour/Liter (µg•h/L)
Standard Deviation NA
Data were naively pooled and the AUC for individual participants was not determined, thus a measure of dispersion is not calculable.
|
113 micrograms•hour/Liter (µg•h/L)
Standard Deviation NA
Data were naively pooled and the AUC for individual participants was not determined, thus a measure of dispersion is not calculable.
|
46 micrograms•hour/Liter (µg•h/L)
Standard Deviation NA
Data were naively pooled and the AUC for individual participants was not determined, thus a measure of dispersion is not calculable.
|
64 micrograms•hour/Liter (µg•h/L)
Standard Deviation NA
Data were naively pooled and the AUC for individual participants was not determined, thus a measure of dispersion is not calculable.
|
—
|
PRIMARY outcome
Timeframe: Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 weeksPopulation: This analysis includes participants with viable samples. Some samples were not able to be reliably analyzed for this outcome.
Blood samples were obtained at the study visits where ketamine was administered to measure the time to peak concentration (Tmax) of intranasal and intravenous ketamine. Time is measured as minutes after administration when the maximum concentration of ketamine in blood is reached.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=7 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=9 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Time to Peak Concentration (Tmax) of Ketamine
|
23 minutes
Standard Deviation 3.0
|
2 minutes
Standard Deviation 1
|
14 minutes
Standard Deviation 3.8
|
16 minutes
Standard Deviation 4.4
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 5, 10, 15, 30, 45, 60, 120, 180, and 240 during Study Visits 1 through 4, up to 4 weeksThe Numerical Pain Rating Scale (NPRS) was used to evaluate patient reported pain. Pain scores were recorded prior to and at 5,10,15, 30, 45, 60, 120, 180 and 240 minutes after administration of ketamine. The NPRS asks participants rate their current level of pain intensity on a scale from 0 (no pain) to 10 (worst possible pain). In general, improvements of pain severity of 1.5 points or less on NPRS could be seen as clinically irrelevant. Above that value, the cutoff point for "clinical relevance" depends on patients' baseline pain severity, and ranges from 2.4 to 5.3. Higher baseline scores require larger raw changes to represent clinically important differences.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Numerical Pain Rating Scale (NPRS) Score
Baseline
|
7.5 units on a scale
Interval 6.0 to 8.0
|
6 units on a scale
Interval 5.0 to 8.0
|
5.5 units on a scale
Interval 5.0 to 7.0
|
6 units on a scale
Interval 6.0 to 8.0
|
—
|
|
Numerical Pain Rating Scale (NPRS) Score
Minute 5
|
6 units on a scale
Interval 5.0 to 8.0
|
1 units on a scale
Interval 0.0 to 3.0
|
5 units on a scale
Interval 4.0 to 6.0
|
5 units on a scale
Interval 3.0 to 5.0
|
—
|
|
Numerical Pain Rating Scale (NPRS) Score
Minute 10
|
6 units on a scale
Interval 5.0 to 8.0
|
0 units on a scale
Interval 0.0 to 3.0
|
3 units on a scale
Interval 3.0 to 6.0
|
4 units on a scale
Interval 2.0 to 5.0
|
—
|
|
Numerical Pain Rating Scale (NPRS) Score
Minute 60
|
4.5 units on a scale
Interval 3.0 to 6.0
|
3.5 units on a scale
Interval 1.0 to 5.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
2 units on a scale
Interval 1.0 to 5.0
|
—
|
|
Numerical Pain Rating Scale (NPRS) Score
Minute 120
|
4.5 units on a scale
Interval 3.0 to 7.0
|
3.5 units on a scale
Interval 1.0 to 4.0
|
3 units on a scale
Interval 2.0 to 3.0
|
2 units on a scale
Interval 1.0 to 5.0
|
—
|
|
Numerical Pain Rating Scale (NPRS) Score
Minute 240
|
5 units on a scale
Interval 3.0 to 7.0
|
3 units on a scale
Interval 1.0 to 4.0
|
3 units on a scale
Interval 3.0 to 4.0
|
5 units on a scale
Interval 2.0 to 6.0
|
—
|
|
Numerical Pain Rating Scale (NPRS) Score
Minute 15
|
5 units on a scale
Interval 4.0 to 7.0
|
1.5 units on a scale
Interval 0.0 to 3.0
|
3.5 units on a scale
Interval 3.0 to 6.0
|
3 units on a scale
Interval 2.0 to 5.0
|
—
|
|
Numerical Pain Rating Scale (NPRS) Score
Minute 30
|
4.5 units on a scale
Interval 2.0 to 7.0
|
2.5 units on a scale
Interval 0.0 to 5.0
|
3.5 units on a scale
Interval 2.0 to 6.0
|
2 units on a scale
Interval 2.0 to 5.0
|
—
|
|
Numerical Pain Rating Scale (NPRS) Score
Minute 45
|
5 units on a scale
Interval 3.0 to 7.0
|
3 units on a scale
Interval 0.0 to 5.0
|
3 units on a scale
Interval 2.0 to 4.0
|
2 units on a scale
Interval 2.0 to 4.0
|
—
|
|
Numerical Pain Rating Scale (NPRS) Score
Minute 180
|
5 units on a scale
Interval 3.0 to 6.0
|
4 units on a scale
Interval 1.0 to 5.0
|
3 units on a scale
Interval 2.0 to 3.0
|
2.5 units on a scale
Interval 1.0 to 6.0
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeksTo evaluate self-reported fatigue, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score
Baseline
|
2.9 units on a scale
Standard Deviation 0.86
|
1.4 units on a scale
Standard Deviation 0.84
|
1.6 units on a scale
Standard Deviation 0.70
|
1.5 units on a scale
Standard Deviation 1.27
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score
Minute 60
|
0.7 units on a scale
Standard Deviation 0.95
|
1.2 units on a scale
Standard Deviation 1.23
|
1.2 units on a scale
Standard Deviation 1.14
|
1.2 units on a scale
Standard Deviation 1.03
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score
Minute 30
|
1 units on a scale
Standard Deviation 1.15
|
1.6 units on a scale
Standard Deviation 1.17
|
1.3 units on a scale
Standard Deviation 1.06
|
1.0 units on a scale
Standard Deviation 1.25
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score
Minute 240
|
0.8 units on a scale
Standard Deviation 0.92
|
1 units on a scale
Standard Deviation 0.82
|
0.8 units on a scale
Standard Deviation 1.03
|
0.7 units on a scale
Standard Deviation 0.67
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeksTo evaluate self-reported dizziness, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score
Baseline
|
0.6 units on a scale
Standard Deviation 0.97
|
0.1 units on a scale
Standard Deviation 0.32
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score
Minute 30
|
0.1 units on a scale
Standard Deviation 0.32
|
0.8 units on a scale
Standard Deviation 1.14
|
0.3 units on a scale
Standard Deviation 0.67
|
0.5 units on a scale
Standard Deviation 0.71
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score
Minute 60
|
0 units on a scale
Standard Deviation 0
|
0.3 units on a scale
Standard Deviation 0.95
|
0.1 units on a scale
Standard Deviation 0.32
|
0.2 units on a scale
Standard Deviation 0.63
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score
Minute 240
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeksTo evaluate self-reported nausea, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score
Baseline
|
0.2 units on a scale
Standard Deviation 0.42
|
0.3 units on a scale
Standard Deviation 0.67
|
0.1 units on a scale
Standard Deviation 0.32
|
0.1 units on a scale
Standard Deviation 0.32
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score
Minute 30
|
0.3 units on a scale
Standard Deviation 0.95
|
0.8 units on a scale
Standard Deviation 1.32
|
0.4 units on a scale
Standard Deviation 0.97
|
0.3 units on a scale
Standard Deviation 0.67
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score
Minute 60
|
0.2 units on a scale
Standard Deviation 0.63
|
0.6 units on a scale
Standard Deviation 1.07
|
0.1 units on a scale
Standard Deviation 0.32
|
0.3 units on a scale
Standard Deviation 0.67
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score
Minute 240
|
0.1 units on a scale
Standard Deviation 0.32
|
0 units on a scale
Standard Deviation 0
|
0.4 units on a scale
Standard Deviation 0.97
|
0.4 units on a scale
Standard Deviation 1.26
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeksTo evaluate self-reported headache, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score
Minute 60
|
0 units on a scale
Standard Deviation 0
|
0.1 units on a scale
Standard Deviation 0.32
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score
Baseline
|
0.2 units on a scale
Standard Deviation 0.63
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score
Minute 30
|
0 units on a scale
Standard Deviation 0
|
0.1 units on a scale
Standard Deviation 0.32
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score
Minute 240
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeksTo evaluate self-reported feeling of unreality, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score
Baseline
|
0.2 units on a scale
Standard Deviation 0.63
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score
Minute 60
|
0 units on a scale
Standard Deviation 0
|
0.5 units on a scale
Standard Deviation 1.27
|
0 units on a scale
Standard Deviation 0
|
0.1 units on a scale
Standard Deviation 0.32
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score
Minute 240
|
0 units on a scale
Standard Deviation 0
|
0.2 units on a scale
Standard Deviation 0.63
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score
Minute 30
|
0.4 units on a scale
Standard Deviation 1.26
|
1.3 units on a scale
Standard Deviation 1.42
|
0.2 units on a scale
Standard Deviation 0.42
|
0.2 units on a scale
Standard Deviation 0.42
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeksTo evaluate self-reported change in hearing, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score
Minute 30
|
0 units on a scale
Standard Deviation 0
|
0.1 units on a scale
Standard Deviation 0.32
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score
Minute 60
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score
Minute 240
|
0 units on a scale
Standard Deviation 0
|
0.3 units on a scale
Standard Deviation 0.95
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score
Baseline
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0.1 units on a scale
Standard Deviation 0.32
|
0 units on a scale
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeksTo evaluate self-reported change in vision, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score
Minute 30
|
0.1 units on a scale
Standard Deviation 0.32
|
0.5 units on a scale
Standard Deviation 0.85
|
0.1 units on a scale
Standard Deviation 0.32
|
0.1 units on a scale
Standard Deviation 0.21
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score
Minute 60
|
0 units on a scale
Standard Deviation 0
|
0.1 units on a scale
Standard Deviation 0.32
|
0 units on a scale
Standard Deviation 0
|
0.1 units on a scale
Standard Deviation 0.32
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score
Baseline
|
0.4 units on a scale
Standard Deviation 0.70
|
0.1 units on a scale
Standard Deviation 0.32
|
0.1 units on a scale
Standard Deviation 0.32
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score
Minute 240
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeksTo evaluate self-reported mood change, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score
Baseline
|
0.5 units on a scale
Standard Deviation 0.85
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0.5 units on a scale
Standard Deviation 1.08
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score
Minute 30
|
0 units on a scale
Standard Deviation 0
|
0.6 units on a scale
Standard Deviation 1.26
|
0.1 units on a scale
Standard Deviation 0.32
|
0.4 units on a scale
Standard Deviation 0.70
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score
Minute 60
|
0 units on a scale
Standard Deviation 0
|
0.4 units on a scale
Standard Deviation 1.26
|
0 units on a scale
Standard Deviation 0
|
0.1 units on a scale
Standard Deviation 0.32
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score
Minute 240
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0.3 units on a scale
Standard Deviation 0.67
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeksTo evaluate self-reported general discomfort, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score
Baseline
|
1.6 units on a scale
Standard Deviation 1.51
|
1.3 units on a scale
Standard Deviation 1.34
|
1.2 units on a scale
Standard Deviation 1.32
|
1.1 units on a scale
Standard Deviation 1.45
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score
Minute 60
|
0.6 units on a scale
Standard Deviation 1.35
|
0.8 units on a scale
Standard Deviation 1.32
|
0.8 units on a scale
Standard Deviation 1.32
|
0.8 units on a scale
Standard Deviation 1.32
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score
Minute 30
|
0.9 units on a scale
Standard Deviation 1.37
|
1.1 units on a scale
Standard Deviation 1.45
|
0.8 units on a scale
Standard Deviation 1.32
|
0.8 units on a scale
Standard Deviation 1.14
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score
Minute 240
|
0.5 units on a scale
Standard Deviation 1.08
|
0.8 units on a scale
Standard Deviation 1.32
|
0.8 units on a scale
Standard Deviation 1.32
|
1.2 units on a scale
Standard Deviation 1.62
|
—
|
PRIMARY outcome
Timeframe: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeksTo evaluate self-reported hallucinations, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score
Baseline
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score
Minute 30
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score
Minute 60
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score
Minute 240
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Baseline and Minute 180, during Study Visits 1 through 5, up to 6 weeksPopulation: The MADRS assessment was only given at the baseline time point during the follow-up visit as no medication was administered during this visit.
Depression was assessed on the Montgomery Asberg Depression Rating Scale (MADRS) during each study visit, before medication administration and 180 minutes after medication administration. The MADRS is designed to be particularly sensitive to treatment effects. The MADRS is a 10-item scale where the survey administrator rates the participant on a variety of aspects related to depression (such as apparent sadness, tension, and pessimistic thoughts) based on a clinical interview. Responses are provided on a scale of 0 to 6 where 0 signifies no difficulties in this area and 6 signifies severe difficulty. Total scores range from 0 to 60 with higher scores indicating greater severity of depression.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
n=10 Participants
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS) Score
Baseline
|
18.7 score on a scale
Standard Deviation 6.57
|
13.4 score on a scale
Standard Deviation 6.40
|
12 score on a scale
Standard Deviation 5.05
|
11.89 score on a scale
Standard Deviation 8.34
|
14.78 score on a scale
Standard Deviation 7.31
|
|
Montgomery Asberg Depression Rating Scale (MADRS) Score
Minute 180
|
13.5 score on a scale
Standard Deviation 4.38
|
13.3 score on a scale
Standard Deviation 5.31
|
11.3 score on a scale
Standard Deviation 6.15
|
9.67 score on a scale
Standard Deviation 8.34
|
—
|
PRIMARY outcome
Timeframe: Baseline during Study Visits 1 through 5, up to 6 weeksThe Edmonton Symptom Assessment System (ESAS) assesses nine symptoms that are common in cancer patients: pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, and well-being. Each symptom is rated on a scale ranging from 0 (absence of symptom) to 10 (worst possible degree of symptom). The ESAS was administered at the baseline time point at each study visit.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
n=10 Participants
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Edmonton Symptom Assessment System (ESAS) Score
Pain
|
6.64 units on a scale
Standard Deviation 1.96
|
6.27 units on a scale
Standard Deviation 2.10
|
5.80 units on a scale
Standard Deviation 1.81
|
5.73 units on a scale
Standard Deviation 2.53
|
5.30 units on a scale
Standard Deviation 1.89
|
|
Edmonton Symptom Assessment System (ESAS) Score
Tiredness
|
6.09 units on a scale
Standard Deviation 1.92
|
4.73 units on a scale
Standard Deviation 2.57
|
4.20 units on a scale
Standard Deviation 2.44
|
4.36 units on a scale
Standard Deviation 2.54
|
3.60 units on a scale
Standard Deviation 2.11
|
|
Edmonton Symptom Assessment System (ESAS) Score
Nausea
|
1.09 units on a scale
Standard Deviation 2.59
|
0.82 units on a scale
Standard Deviation 1.60
|
0.40 units on a scale
Standard Deviation 0.70
|
0.227 units on a scale
Standard Deviation 0.65
|
0 units on a scale
Standard Deviation 0
|
|
Edmonton Symptom Assessment System (ESAS) Score
Lack of Appetite
|
4.55 units on a scale
Standard Deviation 2.77
|
3.45 units on a scale
Standard Deviation 2.38
|
3.00 units on a scale
Standard Deviation 3.02
|
2.20 units on a scale
Standard Deviation 2.10
|
2.20 units on a scale
Standard Deviation 2.20
|
|
Edmonton Symptom Assessment System (ESAS) Score
Shortness of Breath
|
1.55 units on a scale
Standard Deviation 2.70
|
1.09 units on a scale
Standard Deviation 1.97
|
0.40 units on a scale
Standard Deviation 1.26
|
0.18 units on a scale
Standard Deviation 0.60
|
0.60 units on a scale
Standard Deviation 0.97
|
|
Edmonton Symptom Assessment System (ESAS) Score
Depression
|
3.18 units on a scale
Standard Deviation 2.44
|
2.45 units on a scale
Standard Deviation 1.86
|
1.50 units on a scale
Standard Deviation 1.51
|
0.82 units on a scale
Standard Deviation 1.33
|
2.10 units on a scale
Standard Deviation 3.41
|
|
Edmonton Symptom Assessment System (ESAS) Score
Anxiety
|
3.82 units on a scale
Standard Deviation 2.82
|
2.82 units on a scale
Standard Deviation 1.94
|
1.00 units on a scale
Standard Deviation 1.25
|
1.27 units on a scale
Standard Deviation 1.68
|
0.60 units on a scale
Standard Deviation 0.97
|
|
Edmonton Symptom Assessment System (ESAS) Score
Drowsiness
|
4.64 units on a scale
Standard Deviation 2.98
|
3.64 units on a scale
Standard Deviation 2.58
|
2.90 units on a scale
Standard Deviation 2.60
|
3.64 units on a scale
Standard Deviation 2.50
|
2.00 units on a scale
Standard Deviation 2.21
|
|
Edmonton Symptom Assessment System (ESAS) Score
Well-being
|
4.82 units on a scale
Standard Deviation 2.52
|
4.45 units on a scale
Standard Deviation 2.88
|
4.20 units on a scale
Standard Deviation 2.20
|
4.09 units on a scale
Standard Deviation 2.66
|
4.60 units on a scale
Standard Deviation 2.27
|
PRIMARY outcome
Timeframe: Baseline during Visits 1 through 4, up to 4 weeksThe Eastern Cooperative Oncology Group (ECOG) score evaluates performance status of the participants by rating their ability to perform physical tasks and self care. Responses are 0 (fully active), 1 (restricted in physical strenuous activity but ambulatory), 2 (ambulatory and capable of all self-care but unable to carry out work activities), 3 (capable of only limited self-care), 4 (completely disabled), or 5 (dead). The ECOG score will be obtained at the baseline time point at each study visit where medication is administered.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Eastern Cooperative Oncology Group (ECOG) Score
|
2.1 units on a scale
Standard Deviation 0.88
|
2.1 units on a scale
Standard Deviation 0.88
|
1.8 units on a scale
Standard Deviation 0.79
|
1.9 units on a scale
Standard Deviation 0.99
|
—
|
PRIMARY outcome
Timeframe: Baseline during Visit 1 and Visit 5, up to 6 weeksPopulation: One participant did not complete the PROMIS questionnaire at the Follow-up Visit.
The PROMIS Global Health questionnaire, version 1.1, consists of 10 items assessing general domains of health and functioning. Items are scored on a 5-point scale where 1 = poor and 5 = excellent. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better health and functioning, while scores below 50 indicate physical, mental and social health that is below average.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=9 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score
Physical T-Score
|
35.5 T-score
Standard Deviation 5.70
|
33.96 T-score
Standard Deviation 4.24
|
—
|
—
|
—
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score
Mental T-Score
|
43.02 T-score
Standard Deviation 4.17
|
40.52 T-score
Standard Deviation 7.26
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 1 through Visit 5, up to 6 weeksPopulation: Due to inconsistencies with participant-reported pill counts, the data for rescue medication use could not be reliably analyzed.
The opioid sparing effect of NAS ketamine will be determined by evaluating frequency of rescue medications use prior to and during the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 1 through Visit 5, up to 6 weeksPopulation: Due to inconsistencies with participant-reported pill counts, the data for total opioid consumption use could not be reliably analyzed.
The opioid sparing effect of NAS ketamine will be determined by evaluating total opioid consumption (rescue medication) prior to and during the study.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Baseline, Minutes 5, 10, 15, 30, 45, 60, 120, 180, 240, during Study Visits 1 through 4, up to 4 weeksBlood pressure was measured at Baseline and up to 240 minutes after administration of ketamine.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Systolic Blood Pressure
Minute 5
|
117.8 millimeters of mercury (mmHg)
Standard Deviation 19.2
|
134.4 millimeters of mercury (mmHg)
Standard Deviation 30.7
|
119.9 millimeters of mercury (mmHg)
Standard Deviation 20.0
|
118.3 millimeters of mercury (mmHg)
Standard Deviation 14.8
|
—
|
|
Systolic Blood Pressure
Baseline
|
118.6 millimeters of mercury (mmHg)
Standard Deviation 19.7
|
117.5 millimeters of mercury (mmHg)
Standard Deviation 20.8
|
117.6 millimeters of mercury (mmHg)
Standard Deviation 20.0
|
115.8 millimeters of mercury (mmHg)
Standard Deviation 19.3
|
—
|
|
Systolic Blood Pressure
Minute 10
|
122.3 millimeters of mercury (mmHg)
Standard Deviation 19.0
|
129.6 millimeters of mercury (mmHg)
Standard Deviation 23.3
|
122.9 millimeters of mercury (mmHg)
Standard Deviation 20.2
|
120.2 millimeters of mercury (mmHg)
Standard Deviation 19.1
|
—
|
|
Systolic Blood Pressure
Minute 15
|
119.0 millimeters of mercury (mmHg)
Standard Deviation 23.0
|
124.0 millimeters of mercury (mmHg)
Standard Deviation 20.9
|
123.1 millimeters of mercury (mmHg)
Standard Deviation 25.0
|
123.1 millimeters of mercury (mmHg)
Standard Deviation 16.9
|
—
|
|
Systolic Blood Pressure
Minute 30
|
121.7 millimeters of mercury (mmHg)
Standard Deviation 22.0
|
117.2 millimeters of mercury (mmHg)
Standard Deviation 20.6
|
125.4 millimeters of mercury (mmHg)
Standard Deviation 23.0
|
124.9 millimeters of mercury (mmHg)
Standard Deviation 18.1
|
—
|
|
Systolic Blood Pressure
Minute 45
|
119.8 millimeters of mercury (mmHg)
Standard Deviation 22.3
|
117.4 millimeters of mercury (mmHg)
Standard Deviation 15.1
|
121.3 millimeters of mercury (mmHg)
Standard Deviation 18.5
|
117.0 millimeters of mercury (mmHg)
Standard Deviation 18.4
|
—
|
|
Systolic Blood Pressure
Minute 60
|
116.9 millimeters of mercury (mmHg)
Standard Deviation 19.4
|
114.1 millimeters of mercury (mmHg)
Standard Deviation 13.4
|
118.7 millimeters of mercury (mmHg)
Standard Deviation 20.8
|
118.6 millimeters of mercury (mmHg)
Standard Deviation 17.4
|
—
|
|
Systolic Blood Pressure
Minute 120
|
117.2 millimeters of mercury (mmHg)
Standard Deviation 18.9
|
111.5 millimeters of mercury (mmHg)
Standard Deviation 13.4
|
114.9 millimeters of mercury (mmHg)
Standard Deviation 17.8
|
111.5 millimeters of mercury (mmHg)
Standard Deviation 13.0
|
—
|
|
Systolic Blood Pressure
Minute 180
|
111.9 millimeters of mercury (mmHg)
Standard Deviation 24.7
|
115.9 millimeters of mercury (mmHg)
Standard Deviation 15.5
|
116.3 millimeters of mercury (mmHg)
Standard Deviation 19.3
|
111.7 millimeters of mercury (mmHg)
Standard Deviation 13.2
|
—
|
|
Systolic Blood Pressure
Minute 240
|
116.2 millimeters of mercury (mmHg)
Standard Deviation 23.4
|
111.7 millimeters of mercury (mmHg)
Standard Deviation 12.9
|
118.2 millimeters of mercury (mmHg)
Standard Deviation 19.4
|
116.5 millimeters of mercury (mmHg)
Standard Deviation 23.9
|
—
|
POST_HOC outcome
Timeframe: Baseline, Minutes 5, 10, 15, 30, 45, 60, 120, 180, 240, during Study Visits 1 through 4, up to 4 weeksBlood pressure was measured at Baseline and up to 240 minutes after administration of ketamine.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Diastolic Blood Pressure
Minute 15
|
73.4 mmHg
Standard Deviation 6.8
|
78.5 mmHg
Standard Deviation 6.3
|
74.1 mmHg
Standard Deviation 10.6
|
76.8 mmHg
Standard Deviation 8.3
|
—
|
|
Diastolic Blood Pressure
Minute 30
|
74.3 mmHg
Standard Deviation 6.7
|
72.2 mmHg
Standard Deviation 8.1
|
75.9 mmHg
Standard Deviation 11.2
|
77.1 mmHg
Standard Deviation 8.6
|
—
|
|
Diastolic Blood Pressure
Minute 60
|
73.0 mmHg
Standard Deviation 7.3
|
73.6 mmHg
Standard Deviation 6.3
|
75.4 mmHg
Standard Deviation 11.3
|
73.4 mmHg
Standard Deviation 10.5
|
—
|
|
Diastolic Blood Pressure
Baseline
|
72.5 mmHg
Standard Deviation 7.2
|
76.3 mmHg
Standard Deviation 10.7
|
73.5 mmHg
Standard Deviation 9.8
|
72.2 mmHg
Standard Deviation 9.0
|
—
|
|
Diastolic Blood Pressure
Minute 5
|
73.0 mmHg
Standard Deviation 9.1
|
82.4 mmHg
Standard Deviation 11.0
|
72.1 mmHg
Standard Deviation 9.4
|
74.4 mmHg
Standard Deviation 10.1
|
—
|
|
Diastolic Blood Pressure
Minute 10
|
76.6 mmHg
Standard Deviation 7.9
|
81.1 mmHg
Standard Deviation 6.4
|
75.2 mmHg
Standard Deviation 9.8
|
73.2 mmHg
Standard Deviation 11.8
|
—
|
|
Diastolic Blood Pressure
Minute 45
|
74.8 mmHg
Standard Deviation 7.4
|
71.7 mmHg
Standard Deviation 12.3
|
75.5 mmHg
Standard Deviation 10.8
|
73.4 mmHg
Standard Deviation 8.8
|
—
|
|
Diastolic Blood Pressure
Minute 120
|
72.9 mmHg
Standard Deviation 8.9
|
72.9 mmHg
Standard Deviation 7.3
|
72.1 mmHg
Standard Deviation 7.5
|
72.2 mmHg
Standard Deviation 8.1
|
—
|
|
Diastolic Blood Pressure
Minute 180
|
69.1 mmHg
Standard Deviation 11.1
|
71.9 mmHg
Standard Deviation 6.1
|
69.0 mmHg
Standard Deviation 6.5
|
70.8 mmHg
Standard Deviation 10.0
|
—
|
|
Diastolic Blood Pressure
Minute 240
|
73.3 mmHg
Standard Deviation 7.32
|
70.2 mmHg
Standard Deviation 5.5
|
72.7 mmHg
Standard Deviation 6.4
|
75.3 mmHg
Standard Deviation 11.9
|
—
|
POST_HOC outcome
Timeframe: Baseline, Minutes 5, 10, 15, 30, 45, 60, 120, 180, 240, during Study Visits 1 through 4, up to 4 weeksHeart rate was measured at Baseline and up to 240 minutes after administration of ketamine.
Outcome measures
| Measure |
10 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 Participants
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 Participants
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
|---|---|---|---|---|---|
|
Heart Rate
Minute 180
|
79.1 beats per minute
Standard Deviation 20.4
|
76.7 beats per minute
Standard Deviation 15.6
|
78.0 beats per minute
Standard Deviation 16.7
|
80.0 beats per minute
Standard Deviation 16.0
|
—
|
|
Heart Rate
Minute 240
|
80.9 beats per minute
Standard Deviation 21.6
|
80.2 beats per minute
Standard Deviation 17.8
|
74.0 beats per minute
Standard Deviation 13.6
|
79.8 beats per minute
Standard Deviation 14.2
|
—
|
|
Heart Rate
Baseline
|
80.0 beats per minute
Standard Deviation 19.6
|
82.2 beats per minute
Standard Deviation 18.4
|
81.3 beats per minute
Standard Deviation 16.0
|
79.5 beats per minute
Standard Deviation 14.6
|
—
|
|
Heart Rate
Minute 5
|
80.4 beats per minute
Standard Deviation 19.6
|
84.3 beats per minute
Standard Deviation 18.2
|
76.7 beats per minute
Standard Deviation 14.2
|
79.9 beats per minute
Standard Deviation 13.6
|
—
|
|
Heart Rate
Minute 10
|
78.9 beats per minute
Standard Deviation 17.0
|
81.1 beats per minute
Standard Deviation 15.2
|
75.7 beats per minute
Standard Deviation 12.7
|
79.7 beats per minute
Standard Deviation 14.5
|
—
|
|
Heart Rate
Minute 15
|
77.3 beats per minute
Standard Deviation 15.4
|
78.4 beats per minute
Standard Deviation 16.2
|
76.6 beats per minute
Standard Deviation 13.0
|
81.6 beats per minute
Standard Deviation 15.5
|
—
|
|
Heart Rate
Minute 30
|
79.1 beats per minute
Standard Deviation 17.2
|
75.3 beats per minute
Standard Deviation 13.2
|
74.2 beats per minute
Standard Deviation 12.0
|
81.2 beats per minute
Standard Deviation 16.4
|
—
|
|
Heart Rate
Minute 45
|
78.7 beats per minute
Standard Deviation 17.7
|
73.2 beats per minute
Standard Deviation 17.5
|
75.2 beats per minute
Standard Deviation 12.0
|
79.7 beats per minute
Standard Deviation 15.0
|
—
|
|
Heart Rate
Minute 60
|
75.9 beats per minute
Standard Deviation 16.5
|
74.4 beats per minute
Standard Deviation 14.2
|
75.8 beats per minute
Standard Deviation 13.6
|
80.3 beats per minute
Standard Deviation 16.0
|
—
|
|
Heart Rate
Minute 120
|
81.6 beats per minute
Standard Deviation 18.7
|
78.5 beats per minute
Standard Deviation 17.9
|
76.1 beats per minute
Standard Deviation 16.2
|
78.9 beats per minute
Standard Deviation 15.9
|
—
|
Adverse Events
10 mg Intranasal Ketamine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
10 mg Intravenous (IV) Ketamine
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
30 mg Intranasal Ketamine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
50 mg Intranasal Ketamine
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Follow-up Visit
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Phone Call 14 Days Post-Last Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 mg Intranasal Ketamine
n=10 participants at risk
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 participants at risk
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 participants at risk
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 participants at risk
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
n=10 participants at risk
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
Phone Call 14 Days Post-Last Dose
n=10 participants at risk
Participants were called 14 days after the last dose of study medication to assess adverse events.
|
|---|---|---|---|---|---|---|
|
General disorders
Abdominal pain
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neck tumor swelling
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
Other adverse events
| Measure |
10 mg Intranasal Ketamine
n=10 participants at risk
Study participants receiving 10 mg of intranasal ketamine.
|
10 mg Intravenous (IV) Ketamine
n=10 participants at risk
Study participants receiving 10 mg of ketamine intravenously.
|
30 mg Intranasal Ketamine
n=10 participants at risk
Study participants receiving 30 mg of intranasal ketamine.
|
50 mg Intranasal Ketamine
n=10 participants at risk
Study participants receiving 50 mg of intranasal ketamine.
|
Follow-up Visit
n=10 participants at risk
Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
|
Phone Call 14 Days Post-Last Dose
n=10 participants at risk
Participants were called 14 days after the last dose of study medication to assess adverse events.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Eye disorders
Blurry vision
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Burning sensation in nostril
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Cardiac disorders
Bradycardia
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Ear and labyrinth disorders
Change in hearing
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Change in sense of smell
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Dehydration
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Nervous system disorders
Diaphoresis
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Dizziness
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
60.0%
6/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
30.0%
3/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
40.0%
4/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Drowsiness
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
30.0%
3/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Euphoria
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Nervous system disorders
Facial numbnes
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Facial warmth
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Feeling of unreality
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
60.0%
6/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
30.0%
3/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Floating sensation
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Foul taste
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Fuzzy thinking
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Headache
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
40.0%
4/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Vascular disorders
Hypotension
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
In touch with emotions
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Psychiatric disorders
Mood change
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Nausea
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
40.0%
4/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Nervous system disorders
Night sweats
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Nightmares
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Restlessness
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Somnolence
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Nervous system disorders
Tongue numbness
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Vertigo
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Eye disorders
Vision changes
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
20.0%
2/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Visual hallucination
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Intermittent nose bleeds
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
|
General disorders
Abdominal pain
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
10.0%
1/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
0.00%
0/10 • Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place