Trial Outcomes & Findings for Phase 3 Papulopustular Rosacea Study (NCT NCT01493687)
NCT ID: NCT01493687
Last Updated: 2021-02-18
Results Overview
Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
683 participants
Primary outcome timeframe
Week 12
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
CD5024 1% Cream
Part A \& B: CD5024 1% Cream, once daily application
|
CD5024 Vehicle Cream/Azelaic Acid 15% Gel
Part A: CD5024 Vehicle Cream, once daily application
Part B: Azelaic acid 15% Gel, twice daily application
|
|---|---|---|
|
Part A Vehicle Control (12 Weeks)
STARTED
|
451
|
232
|
|
Part A Vehicle Control (12 Weeks)
COMPLETED
|
414
|
210
|
|
Part A Vehicle Control (12 Weeks)
NOT COMPLETED
|
37
|
22
|
|
Part B Long Term Active Control 40 Weeks
STARTED
|
412
|
210
|
|
Part B Long Term Active Control 40 Weeks
COMPLETED
|
351
|
175
|
|
Part B Long Term Active Control 40 Weeks
NOT COMPLETED
|
61
|
35
|
|
Part C Safety Follow up (4 Weeks)
STARTED
|
350
|
175
|
|
Part C Safety Follow up (4 Weeks)
COMPLETED
|
350
|
174
|
|
Part C Safety Follow up (4 Weeks)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
CD5024 1% Cream
Part A \& B: CD5024 1% Cream, once daily application
|
CD5024 Vehicle Cream/Azelaic Acid 15% Gel
Part A: CD5024 Vehicle Cream, once daily application
Part B: Azelaic acid 15% Gel, twice daily application
|
|---|---|---|
|
Part A Vehicle Control (12 Weeks)
Pregnancy
|
2
|
0
|
|
Part A Vehicle Control (12 Weeks)
Lack of Efficacy
|
0
|
1
|
|
Part A Vehicle Control (12 Weeks)
Adverse Event
|
7
|
4
|
|
Part A Vehicle Control (12 Weeks)
Withdrawal by Subject
|
18
|
7
|
|
Part A Vehicle Control (12 Weeks)
Protocol Violation
|
2
|
1
|
|
Part A Vehicle Control (12 Weeks)
Lost to Follow-up
|
7
|
8
|
|
Part A Vehicle Control (12 Weeks)
Other (noted on CRF)
|
1
|
1
|
|
Part B Long Term Active Control 40 Weeks
Pregnancy
|
5
|
1
|
|
Part B Long Term Active Control 40 Weeks
Lack of Efficacy
|
2
|
3
|
|
Part B Long Term Active Control 40 Weeks
Adverse Event
|
5
|
4
|
|
Part B Long Term Active Control 40 Weeks
Withdrawal by Subject
|
27
|
16
|
|
Part B Long Term Active Control 40 Weeks
Protocol Violation
|
1
|
0
|
|
Part B Long Term Active Control 40 Weeks
Lost to Follow-up
|
16
|
10
|
|
Part B Long Term Active Control 40 Weeks
Other (noted on eCRF)
|
5
|
1
|
|
Part C Safety Follow up (4 Weeks)
Adverse Event
|
0
|
1
|
Baseline Characteristics
Phase 3 Papulopustular Rosacea Study
Baseline characteristics by cohort
| Measure |
CD5024 1% Cream
n=451 Participants
Part A: CD5024 1% Cream, once daily application for 12 weeks Part B: CD5024 1% Cream, once daily application for 40 weeks
|
CD5024 Vehicle Cream/Azelaic Acid 15% Gel
n=232 Participants
Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks
|
Total
n=683 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 Years
STANDARD_DEVIATION 12.15 • n=5 Participants
|
51.6 Years
STANDARD_DEVIATION 11.92 • n=7 Participants
|
50.4 Years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
314 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
466 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
396 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
605 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
437 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
657 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Skin Photo Type
I
|
39 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Skin Photo Type
II
|
185 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Skin Photo Type
III
|
167 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Skin Photo Type
IV
|
51 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Skin Photo Type
V
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Skin Photo Type
VI
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: LOCF, ITT
Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)
Outcome measures
| Measure |
CD5024 1% Cream
n=451 Participants
CD5024: CD5024 1% Cream, once daily application for 12 weeks
|
CD5024 Vehicle Cream
n=232 Participants
CD5024 Vehicle Cream, once daily application for 12 weeks
|
|---|---|---|
|
Success Rate
|
38.4 Percentage of participants
|
11.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: LOCF, ITT
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Outcome measures
| Measure |
CD5024 1% Cream
n=451 Participants
CD5024: CD5024 1% Cream, once daily application for 12 weeks
|
CD5024 Vehicle Cream
n=232 Participants
CD5024 Vehicle Cream, once daily application for 12 weeks
|
|---|---|---|
|
Absolute Change in Inflammatory Lesion Count
|
-20.5 Lesion count change
Standard Deviation 15.95
|
-12.0 Lesion count change
Standard Deviation 13.55
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: LOCF, ITT
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Outcome measures
| Measure |
CD5024 1% Cream
n=451 Participants
CD5024: CD5024 1% Cream, once daily application for 12 weeks
|
CD5024 Vehicle Cream
n=232 Participants
CD5024 Vehicle Cream, once daily application for 12 weeks
|
|---|---|---|
|
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
|
-64.9 Percentage of change in lesion counts
Standard Deviation 39.91
|
-41.6 Percentage of change in lesion counts
Standard Deviation 38.83
|
Adverse Events
CD5024 1% Cream - Part A
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
CD5024 Vehicle Cream - Part A
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
CD5024 1% Cream - Part B
Serious events: 7 serious events
Other events: 93 other events
Deaths: 0 deaths
Azelaic Acid 15% Gel - Part B
Serious events: 8 serious events
Other events: 47 other events
Deaths: 0 deaths
CD5024 1% Cream - Part C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
CD5024 1% Cream - Overall
Serious events: 10 serious events
Other events: 110 other events
Deaths: 0 deaths
CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall
Serious events: 9 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CD5024 1% Cream - Part A
n=452 participants at risk
Part A: CD5024 1% Cream, once daily application for 12 weeks
|
CD5024 Vehicle Cream - Part A
n=231 participants at risk
Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
|
CD5024 1% Cream - Part B
n=412 participants at risk
Part B CD5024 1% Cream, once daily application for 40 weeks
|
Azelaic Acid 15% Gel - Part B
n=210 participants at risk
Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
|
CD5024 1% Cream - Part C
n=350 participants at risk
Part C: 4 week safety follow up. No drug applications
|
CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C
n=175 participants at risk
Part C: 4 week safety follow up. No drug applications
|
CD5024 1% Cream - Overall
n=452 participants at risk
Overall number of subjects with adverse events for the entire duration of study
|
CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall
n=232 participants at risk
Overall number of subjects with adverse events for the entire duration of study
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.95%
2/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.86%
2/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Gastrointestinal disorders
Oesophageal ulcer perforation
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.57%
1/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.48%
1/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.48%
1/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.48%
1/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.57%
1/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.48%
1/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.95%
2/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.86%
2/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.95%
2/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.86%
2/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.24%
1/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.22%
1/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Vascular disorders
Shock
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.48%
1/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Vascular disorders
Hypotension
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Vascular disorders
Haemorrhagic anaemia
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.48%
1/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.48%
1/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.48%
1/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.43%
1/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
Other adverse events
| Measure |
CD5024 1% Cream - Part A
n=452 participants at risk
Part A: CD5024 1% Cream, once daily application for 12 weeks
|
CD5024 Vehicle Cream - Part A
n=231 participants at risk
Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
|
CD5024 1% Cream - Part B
n=412 participants at risk
Part B CD5024 1% Cream, once daily application for 40 weeks
|
Azelaic Acid 15% Gel - Part B
n=210 participants at risk
Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
|
CD5024 1% Cream - Part C
n=350 participants at risk
Part C: 4 week safety follow up. No drug applications
|
CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C
n=175 participants at risk
Part C: 4 week safety follow up. No drug applications
|
CD5024 1% Cream - Overall
n=452 participants at risk
Overall number of subjects with adverse events for the entire duration of study
|
CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall
n=232 participants at risk
Overall number of subjects with adverse events for the entire duration of study
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.7%
12/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
2.6%
6/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
13.1%
54/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
14.8%
31/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.29%
1/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
13.9%
63/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
14.7%
34/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
6/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.87%
2/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
7.5%
31/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
6.7%
14/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.57%
2/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
8.2%
37/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
6.9%
16/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
|
Nervous system disorders
Headache
|
2.9%
13/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
1.7%
4/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
4.1%
17/412 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
3.8%
8/210 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.29%
1/350 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
0.00%
0/175 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
5.8%
26/452 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
4.3%
10/232 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
|
Additional Information
Clinical Science Director
Galderma R&D, LLC
Phone: 609-409-7701
Results disclosure agreements
- Principal investigator is a sponsor employee At least sixty (60) days prior to submission for publication, presentation or use, the Institution and the Investigator shall submit in writing to the Contract Research Organization and Sponsor for review and comment any proposed oral or written publication, which period may be extended for an additional thirty (30) days if requested in writing by Contract Research Organization and Sponsor.
- Publication restrictions are in place
Restriction type: OTHER