Trial Outcomes & Findings for Evaluation of Bioavailability of Diclofenac Dermal Products (NCT NCT03145259)

Last Updated: 2020-06-30

Results Overview

Study Session 1: within 60 min prior to dosing, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 24, 27, 30, 32, 51 h Study Session 2: within 60 min prior to dosing, 1, 2, 3, 4, 5, 6, 7, 23, 26, 29, 31, 47 h Study Session 3: no blood samples obtained

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

12 participants

Primary outcome timeframe

blood samples obtained over 51 hour time period for study session 1 and over 47 hour time period for study session 2; through study completion

Results posted on

2020-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	Diclofenac Study Session 1. diclofenac epolamine patch Study Session 2. diclofenac sodium solution Study Session 3. diclofenac epolamine patch pieces and diclofenac sodium solution
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Bioavailability of Diclofenac Dermal Products

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diclofenac n=12 Participants Study Session 1. diclofenac epolamine patch Study Session 2. diclofenac sodium solution Study Session 3. diclofenac epolamine patch pieces and diclofenac sodium solution
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	36 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: blood samples obtained over 51 hour time period for study session 1 and over 47 hour time period for study session 2; through study completion

Outcome measures

Outcome measures
Measure	Diclofenac Epolamine Patches n=12 Participants diclofenac epolamine patches Diclofenac Epolamine Patch: patch	Diclofenac Sodium Solution n=12 Participants diclofenac sodium solution diclofenac sodium solution: solution
Serum Diclofenac Concentrations	5.6 ng/mL Standard Deviation 10.8	40.0 ng/mL Standard Deviation 54.3

Adverse Events

Diclofenac Epolamine Patches

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Diclofenac Sodium Solution

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Diclofenac Epolamine Patches and Diclofenac Sodium Solution

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Audra Stinchcomb

University of Maryland, Baltimore School of Pharmacy

Phone: 410-706-2646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Diclofenac Epolamine Patches n=12 participants at risk diclofenac epolamine patches Diclofenac Epolamine Patch: patch	Diclofenac Sodium Solution n=12 participants at risk diclofenac sodium solution diclofenac sodium solution: solution	Diclofenac Epolamine Patches and Diclofenac Sodium Solution n=12 participants at risk patch pieces and solution Diclofenac Epolamine Patch: patch diclofenac sodium solution: solution
General disorders Menstrual flow	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
Eye disorders decreased blood pressure	41.7% 5/12 • Number of events 5 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	41.7% 5/12 • Number of events 5 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	41.7% 5/12 • Number of events 5 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders increased heart rate	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders raised skin	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders skin hyperpigmentation	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	75.0% 9/12 • Number of events 9 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders abrasions	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders scabs	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	16.7% 2/12 • Number of events 2 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders skin dryness	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	25.0% 3/12 • Number of events 3 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders skin itching	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	50.0% 6/12 • Number of events 6 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	33.3% 4/12 • Number of events 4 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders skin burning sensation	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders skin tingly sensation	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	16.7% 2/12 • Number of events 2 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders skin peeling	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders urticaria	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	8.3% 1/12 • Number of events 2 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders upset stomach/indigestion	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders diarrhea	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders hematoma	8.3% 1/12 • Number of events 1 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	0.00% 0/12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)
General disorders skin erythema (redness)	41.7% 5/12 • Number of events 5 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	83.3% 10/12 • Number of events 10 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)	100.0% 12/12 • Number of events 12 • From the beginning of the study (10/04/17) through when the last adverse event resolved (05/15/20) [2 years, 7 months] TDCLO-001 (431 days), TDCLO-003 (156 days), TDCLO-004 (740 days), TDCLO-010 (37 days), TDCLO-011 (162 days), TDCLO-012 (306 days), TDCLO-013 (500 days), TDCLO-016 (76 days), TDCLO-019 (52 days), TDCLO-020 (213 days), TDCLO-024 (79 days), TDCLO-029 (58 days)