Trial Outcomes & Findings for Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy (NCT NCT04620369)
NCT ID: NCT04620369
Last Updated: 2025-12-03
Results Overview
Response is determined from a patient global impression of change scale and is defined as a patient reporting that the nasal symptom that was most prominent prior to starting the study has been moderately better or very much better 2 weeks after initiating the nasal spray. The number and percentage of patients experiencing a response 2 weeks after initiating\>\>\> the nasal spray will be estimated within each randomized arm and the corresponding two-sided 95% exact (Clopper-Pearson) confidence interval provided. A between-arm comparison of the proportion of patients experiencing a response 2 weeks after initiating the nasal spray will be made using the Fisher's exact test.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
106 participants
Primary outcome timeframe
At 2 weeks after initiating the nasal spray
Results posted on
2025-12-03
Participant Flow
2 patients on Arm A did crossover despite the protocol saying otherwise
Participant milestones
| Measure |
Arm A (Rose Geranium in Sesame Oil Nasal Spray)
Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.
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\>\> Questionnaire Administration: Ancillary studies
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\>\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
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Arm B (Isotonic Nasal Saline)
Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.
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\>\> Placebo Administration: Instill isotonic nasal saline intranasally
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\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Initial Study
STARTED
|
53
|
53
|
|
Initial Study
COMPLETED
|
52
|
50
|
|
Initial Study
NOT COMPLETED
|
1
|
3
|
|
Crossover
STARTED
|
2
|
37
|
|
Crossover
COMPLETED
|
2
|
37
|
|
Crossover
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
Arm A (Rose Geranium in Sesame Oil Nasal Spray)
n=43 Participants
Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\> \>\>\>
\>
\>\>\> Questionnaire Administration: Ancillary studies\>
\>\>\>
\>
\>\>\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
|
Arm B (Isotonic Nasal Saline)
n=41 Participants
Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\> \>\>\>
\>
\>\>\> Questionnaire Administration: Ancillary studies\>
\>\>\>
\>
\>\>\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 12.3 • n=3 Participants
|
59.3 years
STANDARD_DEVIATION 12.3 • n=3 Participants
|
59.3 years
STANDARD_DEVIATION 12.3 • n=6 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=3 Participants
|
37 Participants
n=3 Participants
|
73 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=3 Participants
|
40 Participants
n=3 Participants
|
83 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=3 Participants
|
40 Participants
n=3 Participants
|
80 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Prior treatments for nose symptoms
0
|
32 Participants
n=3 Participants
|
25 Participants
n=3 Participants
|
57 Participants
n=6 Participants
|
|
Prior treatments for nose symptoms
1
|
7 Participants
n=3 Participants
|
11 Participants
n=3 Participants
|
18 Participants
n=6 Participants
|
|
Prior treatments for nose symptoms
2
|
2 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
|
Prior treatments for nose symptoms
3+
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Prior history of allergies or asthma
|
16 Participants
n=3 Participants
|
15 Participants
n=3 Participants
|
31 Participants
n=6 Participants
|
|
Currently smoking
No
|
36 Participants
n=3 Participants
|
37 Participants
n=3 Participants
|
73 Participants
n=6 Participants
|
|
Currently smoking
Yes
|
7 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
|
Taking aspirin or blood thinners
|
8 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
|
Most bothersome nasal symptom
Dryness
|
15 Participants
n=3 Participants
|
15 Participants
n=3 Participants
|
30 Participants
n=6 Participants
|
|
Most bothersome nasal symptom
Discomfort
|
7 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
|
Most bothersome nasal symptom
Bleeding
|
19 Participants
n=3 Participants
|
10 Participants
n=3 Participants
|
29 Participants
n=6 Participants
|
|
Most bothersome nasal symptom
Scabbing
|
0 Participants
n=3 Participants
|
7 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
|
Most bothersome nasal symptom
Sores
|
2 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: At 2 weeks after initiating the nasal sprayResponse is determined from a patient global impression of change scale and is defined as a patient reporting that the nasal symptom that was most prominent prior to starting the study has been moderately better or very much better 2 weeks after initiating the nasal spray. The number and percentage of patients experiencing a response 2 weeks after initiating\>\>\> the nasal spray will be estimated within each randomized arm and the corresponding two-sided 95% exact (Clopper-Pearson) confidence interval provided. A between-arm comparison of the proportion of patients experiencing a response 2 weeks after initiating the nasal spray will be made using the Fisher's exact test.
Outcome measures
| Measure |
Arm A (Rose Geranium in Sesame Oil Nasal Spray)
n=43 Participants
Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\>\>\> \>\>\> Questionnaire Administration: Ancillary studies\>\>\>
\>\>\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
|
Arm B (Isotonic Nasal Saline)
n=41 Participants
Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.\>\>\> \>\>\> Placebo Administration: Instill isotonic nasal saline intranasally\>\>\>
\>\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Response
worsening of nasal symptoms
|
2 Participants
|
4 Participants
|
|
Response
no change
|
1 Participants
|
12 Participants
|
|
Response
some nasal symptom improvement
|
40 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Up to 2 weeks after initiating the nasal sprayFor the most prominent nasal symptom indicated at baseline, patients will record the severity on an ordinal scale of 1=mild, 2=moderate, 3=severe, and 4=very severe. Two weeks after initiating the nasal spray the patients will record the severity of the most prominent nasal symptom as 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. A shift table will be created to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift two-weeks after initiating the nasal spray. In addition, the within-patient change in severity of the most prominent nasal symptom will be calculated 2 weeks after initiating the nasal spray and summarized descriptively within each arm. The Wilcoxon rank-sum test will be performed, and the methods of Hodges and Lehmann will be applied to compute a point estimate and confidence interval for the difference in medians between the two arms.
Outcome measures
| Measure |
Arm A (Rose Geranium in Sesame Oil Nasal Spray)
n=43 Participants
Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\>\>\> \>\>\> Questionnaire Administration: Ancillary studies\>\>\>
\>\>\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
|
Arm B (Isotonic Nasal Saline)
n=41 Participants
Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.\>\>\> \>\>\> Placebo Administration: Instill isotonic nasal saline intranasally\>\>\>
\>\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Severity of Most Prominent Nasal Symptom Indicated at Baseline
Week 0
|
100 "percentage of Week 0 score
Standard Deviation 0
|
100 "percentage of Week 0 score
Standard Deviation 0
|
|
Severity of Most Prominent Nasal Symptom Indicated at Baseline
Week 1
|
70.155 "percentage of Week 0 score
Standard Deviation 4.520
|
91.458 "percentage of Week 0 score
Standard Deviation 5.598
|
|
Severity of Most Prominent Nasal Symptom Indicated at Baseline
Week 2
|
65.0 "percentage of Week 0 score
Standard Deviation 5.154
|
77.724 "percentage of Week 0 score
Standard Deviation 4.890
|
SECONDARY outcome
Timeframe: Up to 2 weeks after initiating the nasal sprayPopulation: Some patients missed their post-baseline assessment
Each nasal symptom (dryness, pain, bleeding, and scabbing) will be descriptively summarized, tabulated, and plotted according to arm at baseline, and at 1 and 2 weeks post-baseline; additionally, will group patients according to baseline severity for each symptom and summarize changes over time and according to arm. Shift tables will also be generated to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift one- and two-weeks after initiating the nasal spray. The Nasal symptom scale is 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe with very severe being the worst outcome.
Outcome measures
| Measure |
Arm A (Rose Geranium in Sesame Oil Nasal Spray)
n=43 Participants
Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\>\>\> \>\>\> Questionnaire Administration: Ancillary studies\>\>\>
\>\>\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
|
Arm B (Isotonic Nasal Saline)
n=41 Participants
Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.\>\>\> \>\>\> Placebo Administration: Instill isotonic nasal saline intranasally\>\>\>
\>\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Nasal Symptom Analysis
Dryness Week 0
|
2.95 score on a scale
Interval 2.68 to 3.23
|
3.14 score on a scale
Interval 2.91 to 3.39
|
|
Nasal Symptom Analysis
Dryness Week 1
|
2.02 score on a scale
Interval 1.79 to 2.26
|
2.8 score on a scale
Interval 2.56 to 3.04
|
|
Nasal Symptom Analysis
Dryness Week 2
|
2 score on a scale
Interval 1.72 to 2.28
|
2.46 score on a scale
Interval 2.15 to 2.77
|
|
Nasal Symptom Analysis
Tenderness/Discomfort Week 0
|
2.63 score on a scale
Interval 2.29 to 2.96
|
2.46 score on a scale
Interval 2.14 to 2.79
|
|
Nasal Symptom Analysis
Tenderness/Discomfort Week 1
|
1.65 score on a scale
Interval 1.4 to 1.9
|
2.25 score on a scale
Interval 1.91 to 2.59
|
|
Nasal Symptom Analysis
Tenderness/Discomfort Week 2
|
1.67 score on a scale
Interval 1.38 to 1.96
|
1.98 score on a scale
Interval 1.64 to 2.31
|
|
Nasal Symptom Analysis
Bleeding Week 0
|
2.56 score on a scale
Interval 2.24 to 2.88
|
2.68 score on a scale
Interval 2.36 to 3.0
|
|
Nasal Symptom Analysis
Bleeding Week 1
|
2 score on a scale
Interval 1.69 to 2.31
|
2.48 score on a scale
Interval 2.18 to 2.77
|
|
Nasal Symptom Analysis
Bleeding Week 2
|
1.72 score on a scale
Interval 1.42 to 2.02
|
2 score on a scale
Interval 1.71 to 2.29
|
|
Nasal Symptom Analysis
Scabbing Week 0
|
2.72 score on a scale
Interval 2.4 to 3.05
|
2.49 score on a scale
Interval 2.13 to 2.84
|
|
Nasal Symptom Analysis
Scabbing Week 1
|
1.74 score on a scale
Interval 1.48 to 2.0
|
2.25 score on a scale
Interval 1.95 to 2.55
|
|
Nasal Symptom Analysis
Scabbing Week 2
|
1.63 score on a scale
Interval 1.36 to 1.9
|
2.17 score on a scale
Interval 1.83 to 2.52
|
|
Nasal Symptom Analysis
Sores Week 0
|
2.14 score on a scale
Interval 1.84 to 2.44
|
1.93 score on a scale
Interval 1.59 to 2.27
|
|
Nasal Symptom Analysis
Sores Week 1
|
1.58 score on a scale
Interval 1.32 to 1.84
|
1.8 score on a scale
Interval 1.51 to 2.09
|
|
Nasal Symptom Analysis
Sores Week 2
|
1.47 score on a scale
Interval 1.21 to 1.72
|
1.78 score on a scale
Interval 1.48 to 2.08
|
|
Nasal Symptom Analysis
Most Prominent Symptom Week 0
|
3.09 score on a scale
Interval 2.82 to 3.37
|
3.17 score on a scale
Interval 2.92 to 3.42
|
|
Nasal Symptom Analysis
Most Prominent Symptom Week 1
|
2.09 score on a scale
Interval 1.79 to 2.39
|
2.73 score on a scale
Interval 2.46 to 2.99
|
|
Nasal Symptom Analysis
Most Prominent Symptom Week 2
|
1.93 score on a scale
Interval 1.63 to 2.22
|
2.39 score on a scale
Interval 2.09 to 2.69
|
SECONDARY outcome
Timeframe: Up to 2 weeks after initiating the nasal sprayThe constellation of AEs as scored using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 will be summarized within arms by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles associated with each arm, the maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns and compared between arms using Wilcoxon tests.
Outcome measures
| Measure |
Arm A (Rose Geranium in Sesame Oil Nasal Spray)
n=43 Participants
Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\>\>\> \>\>\> Questionnaire Administration: Ancillary studies\>\>\>
\>\>\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
|
Arm B (Isotonic Nasal Saline)
n=41 Participants
Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.\>\>\> \>\>\> Placebo Administration: Instill isotonic nasal saline intranasally\>\>\>
\>\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Grade 3
|
0 Participants
|
0 Participants
|
Adverse Events
Arm A (Rose Geranium in Sesame Oil Nasal Spray)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm B (Isotonic Nasal Saline)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm A Crossover
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B Crossover
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A (Rose Geranium in Sesame Oil Nasal Spray)
n=53 participants at risk
Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
|
Arm B (Isotonic Nasal Saline)
n=53 participants at risk
Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
|
Arm A Crossover
n=2 participants at risk
Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
|
Arm B Crossover
n=37 participants at risk
Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally
|
|---|---|---|---|---|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
2.7%
1/37 • Number of events 1 • Up to 2 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
5.4%
2/37 • Number of events 2 • Up to 2 weeks
|
|
Investigations
White blood cell decreased
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
2.7%
1/37 • Number of events 1 • Up to 2 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Nervous system disorders
Dysgeusia
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Nervous system disorders
Headache
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
3.8%
2/53 • Number of events 2 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
2.7%
1/37 • Number of events 1 • Up to 2 weeks
|
|
Nervous system disorders
Paresthesia
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
1.9%
1/53 • Number of events 2 • Up to 2 weeks
|
3.8%
2/53 • Number of events 2 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Vascular disorders
Thromboembolic event
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53 • Number of events 3 • Up to 2 weeks
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
2.7%
1/37 • Number of events 1 • Up to 2 weeks
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
General disorders
Fatigue
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/53 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
General disorders
Flu like symptoms
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
5.7%
3/53 • Number of events 3 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
2.7%
1/37 • Number of events 1 • Up to 2 weeks
|
|
General disorders
Pain
|
0.00%
0/53 • Up to 2 weeks
|
3.8%
2/53 • Number of events 2 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.00%
0/53 • Up to 2 weeks
|
1.9%
1/53 • Number of events 1 • Up to 2 weeks
|
0.00%
0/2 • Up to 2 weeks
|
0.00%
0/37 • Up to 2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place