Trial Outcomes & Findings for Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma (NCT NCT00754494)
NCT ID: NCT00754494
Last Updated: 2015-01-06
Results Overview
Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
From baseline to post-treatment (up to 30 days)
Results posted on
2015-01-06
Participant Flow
Participant milestones
| Measure |
Arm I (25 mg)
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (50 mg)
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm III (100 mg)
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma
Baseline characteristics by cohort
| Measure |
Arm I (25 mg)
n=15 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (50 mg)
n=15 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm III (100 mg)
n=15 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.67 years
STANDARD_DEVIATION 4.43 • n=5 Participants
|
62.47 years
STANDARD_DEVIATION 6.03 • n=7 Participants
|
60.67 years
STANDARD_DEVIATION 7.42 • n=5 Participants
|
62.27 years
STANDARD_DEVIATION 6.08 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to post-treatment (up to 30 days)Population: Change in ACF pERK levels not reported as the assay did not demonstrate signaling
Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to post-treatment (up to 30 days)Population: Outcome measure data is reported based on the evaluable samples collected and available results.
pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Outcome measures
| Measure |
Arm I (25 mg)
n=14 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=14 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=13 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Change in EGF-inducible Markers - pEGFR in Normal Mucosa
|
0.84 expression level
Interval 0.27 to 2.58
|
1.65 expression level
Interval 0.87 to 3.1
|
0.97 expression level
Interval 0.68 to 1.38
|
SECONDARY outcome
Timeframe: From baseline to post-treatment (up to 30 days)Population: Outcome measure data is reported based on the evaluable samples collected and available results.
Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Outcome measures
| Measure |
Arm I (25 mg)
n=14 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=14 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=13 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Change in EGF-inducible Markers - Total EGFR in Normal Mucosa
|
2.02 expression level
Interval 0.44 to 9.4
|
1.91 expression level
Interval 0.91 to 4.0
|
1.23 expression level
Interval 0.88 to 1.72
|
SECONDARY outcome
Timeframe: From baseline to post-treatment (up to 30 days)Population: Outcome measure data is reported based on the evaluable samples collected and available results.
pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Outcome measures
| Measure |
Arm I (25 mg)
n=14 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=14 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=14 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Change in EGF-inducible Markers - pEGFR in ACF
|
1.19 expression level
Interval 0.57 to 2.48
|
1.93 expression level
Interval 1.07 to 3.48
|
1.40 expression level
Interval 0.78 to 2.53
|
SECONDARY outcome
Timeframe: From baseline to post-treatment (up to 30 days)Population: Outcome measure data is reported based on the evaluable samples collected and available results.
Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Outcome measures
| Measure |
Arm I (25 mg)
n=14 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=14 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=14 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Change in EGF-inducible Markers - Total EGFR in ACF
|
1.33 expression level
Interval 0.38 to 4.61
|
2.22 expression level
Interval 1.08 to 4.54
|
1.94 expression level
Interval 0.92 to 4.09
|
SECONDARY outcome
Timeframe: Up to day 30Population: ACF: pERK ratio not reported as the assay did not demonstrate signaling in ACF pERK levels
Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 30Population: Outcome measure data is reported based on the evaluable samples collected and available results.
Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Outcome measures
| Measure |
Arm I (25 mg)
n=14 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=14 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=13 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Plasma Erlotinib Concentration (ng/mL)
|
232.29 ng/mL
Standard Deviation 160.6
|
486.56 ng/mL
Standard Deviation 211.8
|
1280.84 ng/mL
Standard Deviation 788.3
|
SECONDARY outcome
Timeframe: Up to day 30Population: Outcome measure data is reported based on the evaluable samples collected and available results.
Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Outcome measures
| Measure |
Arm I (25 mg)
n=13 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=14 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=13 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Plasma OSI-420 Concentration (ng/mL)
|
17.77 ng/mL
Standard Deviation 12.3
|
33.87 ng/mL
Standard Deviation 14.1
|
117.98 ng/mL
Standard Deviation 84.5
|
SECONDARY outcome
Timeframe: Up to day 30Population: Outcome measure data is reported based on the evaluable samples collected and available results.
Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Outcome measures
| Measure |
Arm I (25 mg)
n=12 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=12 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=12 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Normal Mucosa Erlotinib Concentration (ng/mg)
|
0.36 ng/mg
Standard Deviation 0.18
|
1.38 ng/mg
Standard Deviation 1.23
|
3.25 ng/mg
Standard Deviation 4.62
|
SECONDARY outcome
Timeframe: Up to day 30Population: Outcome measure data is reported based on the evaluable samples collected and available results.
Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Outcome measures
| Measure |
Arm I (25 mg)
n=4 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=10 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=11 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Normal Mucosa OSI-420 Concentration (ng/mg)
|
0.04 ng/mg
Standard Deviation 0.01
|
0.17 ng/mg
Standard Deviation 0.15
|
0.29 ng/mg
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: Up to 9 weeksDescribed for each arm using frequencies. The onset of adverse events is between randomization date and off-study date.
Outcome measures
| Measure |
Arm I (25 mg)
n=15 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=15 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=15 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Number of Participants Reported at Least 1 Side Effect During the Study
At least 1 adverse event reported
|
12 participants
|
13 participants
|
13 participants
|
|
Number of Participants Reported at Least 1 Side Effect During the Study
No adverse event reported
|
3 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 9 weeksDescribed for each arm using frequencies.
Outcome measures
| Measure |
Arm I (25 mg)
n=15 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=15 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=15 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Number of Participants Reported at Least 1 Rash Side Effect During the Study
At least 1 rash AE reported
|
5 participants
|
6 participants
|
12 participants
|
|
Number of Participants Reported at Least 1 Rash Side Effect During the Study
No rash AE reported
|
10 participants
|
9 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Up to 9 weeksDescribed for each arm using frequencies.
Outcome measures
| Measure |
Arm I (25 mg)
n=15 Participants
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days
|
Arm II (50 mg)
n=15 Participants
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days
|
Arm III (100 mg)
n=15 Participants
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days
|
|---|---|---|---|
|
Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study
At least 1 diarrhea AE reported
|
4 participants
|
4 participants
|
5 participants
|
|
Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study
No diarrhea AE reported
|
11 participants
|
11 participants
|
10 participants
|
Adverse Events
Arm I (25 mg)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm II (50 mg)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm III (100 mg)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (25 mg)
n=15 participants at risk
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (50 mg)
n=15 participants at risk
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm III (100 mg)
n=15 participants at risk
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Cardiac disorders
CHEST PAIN
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
Other adverse events
| Measure |
Arm I (25 mg)
n=15 participants at risk
Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (50 mg)
n=15 participants at risk
Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm III (100 mg)
n=15 participants at risk
Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
80% DIMINISHED SEBORRHEIC KERATOSIS SKIN LESIONS
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
ALLERGIC REACTION: RASH ON THE FACE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Respiratory, thoracic and mediastinal disorders
BLOODY NOSE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Renal and urinary disorders
BLUE COLORED URINE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Renal and urinary disorders
BLUE/GREEN COLORED URINE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Eye disorders
BLURRING OF VISION
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
CANKER SORES
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
CLEARED UP ACNE ON MY FOREHEAD
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
General disorders
COLD
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
13.3%
2/15 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Musculoskeletal and connective tissue disorders
DEEP BRUISED LFT LEG PAIN
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
DIARRHEA
|
20.0%
3/15 • Number of events 3 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
20.0%
3/15 • Number of events 4 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
26.7%
4/15 • Number of events 5 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
DIARRHEA-FREQUENT BM'S
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
13.3%
2/15 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
DRY & ITCHY SKIN
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Eye disorders
DRY EYE
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Eye disorders
DRY EYES
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
13.3%
2/15 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Eye disorders
DRY ITCHY EYE
|
13.3%
2/15 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
20.0%
3/15 • Number of events 3 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
13.3%
2/15 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
33.3%
5/15 • Number of events 5 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN AROUND NOSE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN ON NOSE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN-(LEGS)
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Eye disorders
DRYNESS OF EYES
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
DRYNESS OF SKIN ON FACE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Musculoskeletal and connective tissue disorders
DULL SORENESS IN LEG
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Ear and labyrinth disorders
EARACHE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
FACE PIMPLES
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
FACE SORE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
General disorders
FATIGUE
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
20.0%
3/15 • Number of events 3 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
General disorders
FLU
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
FOLLICULAR RASH ON TORSO
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Nervous system disorders
HEADACHE
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
HEARTBURN
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
INCARCERATED HERNIA
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Psychiatric disorders
IRRITABLE-MOOD ALTERATION
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Eye disorders
ITCHINESS OF EYES
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Nervous system disorders
LIGHT HEADED
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
LOOSE STOOLS
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
LOSS OF APPETITE
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
LOTS OF GAS
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
MILD DIARRHEA
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
MILD INDIGESTION
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
MILD RASH IN THE BUTTOCK
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
MOUTH SORES
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
NAUSEA
|
13.3%
2/15 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
13.3%
2/15 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Respiratory, thoracic and mediastinal disorders
NOSE BLEED
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
PAIN ON ABDOMEN
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Musculoskeletal and connective tissue disorders
PAIN ON FOOT
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
PAINFUL ITCHY & TENDER SCALP
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RASH
|
20.0%
3/15 • Number of events 3 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
26.7%
4/15 • Number of events 4 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RASH ON CHEST
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
13.3%
2/15 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RASH ON FACE, CHEST AND SHOULDER
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RASH ON FACE, CHEST, AND BEHIND EARS
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RASH ON FACE, SCALP AND CHEST
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RASH ON FACE, SCALP, CHEST
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RASH ON FACE, SCALP, CHEST, BACK, EXTREMITIES
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RASH ON FOOT
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RASH ON FOREHEAD/NOSE/CHEST
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RAW NOSE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RED ITCHY FACE RASH ON CHEEKS & NOSE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Eye disorders
RED PUFFY EYES
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RED RASH-FACE PEELING & NOW WHITE HEAD PIMPLES
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RED RASH-FACE,NOSE, & CHEST
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RED RASH-FACE-NECK-CHEST & SCALP-ITCHY
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
RED,BUMPY FACE & CHEST RASH
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Respiratory, thoracic and mediastinal disorders
RUNNY NOSE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Eye disorders
SEEING BLACK SPOTS AND FLASHING LIGHTS IN LEFT EYE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Respiratory, thoracic and mediastinal disorders
SHORT OF BREATH EASILY
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Respiratory, thoracic and mediastinal disorders
SHORT OF BREATH-DYSPNEA
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
SWOLLEN FACE
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Musculoskeletal and connective tissue disorders
SWOLLEN LEFT KNEE
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Skin and subcutaneous tissue disorders
ULCER ON MUCOUS MEMBRANE IN MOUTH
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
|
Gastrointestinal disorders
VOMIT
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
6.7%
1/15 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
0.00%
0/15 • The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60