Trial Outcomes & Findings for Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder (NCT NCT01192568)

NCT ID: NCT01192568

Last Updated: 2024-09-04

Results Overview

The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

Baseline (Week 0) up to Week 6

Results posted on

2024-09-04

Participant Flow

This 2-part pediatric study, was initiated as a double-blind (DB), placebo-controlled study with an open-label (OL) extension (Protocol Amendment 3). In Part 1 (Pre-Amendment 3), subjects were randomized into DB: Placebo (Pre-Amend 3) or DB: OTG (Pre-Amend 3) treatment groups for 6 weeks, then all subjects were placed into OL: OTG (Pre-Amend 3) for 8 weeks. In Part 2 (Post-Amendment 3), newly enrolled subjects were placed into OL: OTG (Post-Amend 3) for 14 weeks.

Participant milestones

Participant milestones
Measure	DB: Placebo (Pre-Amend 3) Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period to generate additional safety data.	DB: OTG (Pre-Amend 3) Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OTG for 8-week period to generate additional safety data.	OL: OTG (Pre-Amend 3) Following the DB Period: Subjects received Open-Label (OL) oxybutynin chloride gel (OTG) for 8 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day.	OL: OTG (Post-Amend 3) Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day.
Double Blind Pre-Amendment 3 STARTED	16	17	0	0
Double Blind Pre-Amendment 3 COMPLETED	16	17	0	0
Double Blind Pre-Amendment 3 NOT COMPLETED	0	0	0	0
Open Label Pre-Amendment 3 STARTED	0	0	33	0
Open Label Pre-Amendment 3 COMPLETED	0	0	32	0
Open Label Pre-Amendment 3 NOT COMPLETED	0	0	1	0
Open Label Post-Amendment 3 STARTED	0	0	0	19
Open Label Post-Amendment 3 COMPLETED	0	0	0	18
Open Label Post-Amendment 3 NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	DB: Placebo (Pre-Amend 3) Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period to generate additional safety data.	DB: OTG (Pre-Amend 3) Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OTG for 8-week period to generate additional safety data.	OL: OTG (Pre-Amend 3) Following the DB Period: Subjects received Open-Label (OL) oxybutynin chloride gel (OTG) for 8 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day.	OL: OTG (Post-Amend 3) Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day.
Open Label Pre-Amendment 3 Adverse Event	0	0	1	0
Open Label Post-Amendment 3 Adverse Event	0	0	0	1

Baseline Characteristics

ITT Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DB: Placebo (Pre-Amend 3) n=16 Participants Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period to generate additional safety data.	DB: OTG (Pre-Amend 3) n=17 Participants Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OTG for 8-week period to generate additional safety data.	OL: OTG (Post-Amend 3) n=19 Participants Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day.	Total n=52 Participants Total of all reporting groups
Age, Continuous	9.7 years STANDARD_DEVIATION 3.11 • n=16 Participants	9.6 years STANDARD_DEVIATION 2.71 • n=17 Participants	7.7 years STANDARD_DEVIATION 3.41 • n=19 Participants	9.0 years STANDARD_DEVIATION 3.19 • n=52 Participants
Sex: Female, Male Female	8 Participants n=16 Participants	10 Participants n=17 Participants	10 Participants n=19 Participants	28 Participants n=52 Participants
Sex: Female, Male Male	8 Participants n=16 Participants	7 Participants n=17 Participants	9 Participants n=19 Participants	24 Participants n=52 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=16 Participants	4 Participants n=17 Participants	7 Participants n=19 Participants	16 Participants n=52 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=16 Participants	13 Participants n=17 Participants	12 Participants n=19 Participants	36 Participants n=52 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants	0 Participants n=17 Participants	0 Participants n=19 Participants	0 Participants n=52 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=16 Participants	0 Participants n=17 Participants	1 Participants n=19 Participants	1 Participants n=52 Participants
Race (NIH/OMB) Asian	1 Participants n=16 Participants	1 Participants n=17 Participants	0 Participants n=19 Participants	2 Participants n=52 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants	0 Participants n=17 Participants	1 Participants n=19 Participants	1 Participants n=52 Participants
Race (NIH/OMB) Black or African American	4 Participants n=16 Participants	5 Participants n=17 Participants	1 Participants n=19 Participants	10 Participants n=52 Participants
Race (NIH/OMB) White	10 Participants n=16 Participants	11 Participants n=17 Participants	15 Participants n=19 Participants	36 Participants n=52 Participants
Race (NIH/OMB) More than one race	0 Participants n=16 Participants	0 Participants n=17 Participants	1 Participants n=19 Participants	1 Participants n=52 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=16 Participants	0 Participants n=17 Participants	0 Participants n=19 Participants	1 Participants n=52 Participants
Percent of Catheterizations without Leaking Week 0 (Baseline)	32.98 percentage of catheterizations wo leak STANDARD_DEVIATION 32.708 • n=16 Participants • ITT Population	27.88 percentage of catheterizations wo leak STANDARD_DEVIATION 35.225 • n=17 Participants • ITT Population	18.63 percentage of catheterizations wo leak STANDARD_DEVIATION 27.078 • n=18 Participants • ITT Population	23.12 percentage of catheterizations wo leak STANDARD_DEVIATION 31.185 • n=51 Participants • ITT Population

PRIMARY outcome

Timeframe: Baseline (Week 0) up to Week 6

Population: ITT Population

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period.	OTG (Pre-Amend 3) n=17 Participants All randomized subjects who have at least 1 post-baseline value for efficacy variable for both the DB and OL periods before Protocol Amendment 3. Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OG for 8-week period.	OTG (Post-Amend 3) n=18 Participants All subjects who receive at least 1 dose of study treatment and have at least 1 post-baseline value for the efficacy variable in the Post-Amendment 3 OL period. Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day.	Combined OTG n=35 Participants All subjects who receive at least 1 dose of study treatment and have at least 1 post-baseline value for the primary efficacy variable in the Post-Amendment 3 open-label period and all randomized subjects who have at least 1 post-baseline value for the efficacy variable in the Pre-Amendment 3 double-blind period.
Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6	-0.45 percentage of point Standard Deviation 20.178	16.91 percentage of point Standard Deviation 36.681	13.82 percentage of point Standard Deviation 22.978	15.32 percentage of point Standard Deviation 29.994

SECONDARY outcome

Timeframe: Baseline (Week 0) up to week 6

Population: ITT Population

Pre-Amendment 3: Change from Baseline in Average Volume of Urine Collected per Catheterization at week 6 (calculated from the 2-day urinary diary data).

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period.	OTG (Pre-Amend 3) n=17 Participants All randomized subjects who have at least 1 post-baseline value for efficacy variable for both the DB and OL periods before Protocol Amendment 3. Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OG for 8-week period.	OTG (Post-Amend 3) All subjects who receive at least 1 dose of study treatment and have at least 1 post-baseline value for the efficacy variable in the Post-Amendment 3 OL period. Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day.	Combined OTG All subjects who receive at least 1 dose of study treatment and have at least 1 post-baseline value for the primary efficacy variable in the Post-Amendment 3 open-label period and all randomized subjects who have at least 1 post-baseline value for the efficacy variable in the Pre-Amendment 3 double-blind period.
Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6	-24.59 mL Standard Deviation 38.138	14.33 mL Standard Deviation 38.781	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 6

Population: ITT Population

Change from Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at week 6 (calculated from the 2-day urinary diary data).

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period.	OTG (Pre-Amend 3) n=17 Participants All randomized subjects who have at least 1 post-baseline value for efficacy variable for both the DB and OL periods before Protocol Amendment 3. Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OG for 8-week period.	OTG (Post-Amend 3) n=18 Participants All subjects who receive at least 1 dose of study treatment and have at least 1 post-baseline value for the efficacy variable in the Post-Amendment 3 OL period. Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day.	Combined OTG n=35 Participants All subjects who receive at least 1 dose of study treatment and have at least 1 post-baseline value for the primary efficacy variable in the Post-Amendment 3 open-label period and all randomized subjects who have at least 1 post-baseline value for the efficacy variable in the Pre-Amendment 3 double-blind period.
Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6	-12.03 mL Standard Deviation 88.116	14.18 mL Standard Deviation 58.694	29.78 mL Standard Deviation 87.808	22.20 mL Standard Deviation 74.424

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 6

Population: ITT

Change from Baseline in Average Number of Catheterizations Per Day at Week 6 (calculated from the 2-day urinary diary data).

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period.	OTG (Pre-Amend 3) n=17 Participants All randomized subjects who have at least 1 post-baseline value for efficacy variable for both the DB and OL periods before Protocol Amendment 3. Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OG for 8-week period.	OTG (Post-Amend 3) n=18 Participants All subjects who receive at least 1 dose of study treatment and have at least 1 post-baseline value for the efficacy variable in the Post-Amendment 3 OL period. Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day.	Combined OTG n=35 Participants All subjects who receive at least 1 dose of study treatment and have at least 1 post-baseline value for the primary efficacy variable in the Post-Amendment 3 open-label period and all randomized subjects who have at least 1 post-baseline value for the efficacy variable in the Pre-Amendment 3 double-blind period.
Change From Baseline in Average Number of Catheterizations Per Day at Week 6	0.19 Number of Catheterizations Per Day Standard Error 0.512	-0.03 Number of Catheterizations Per Day Standard Error 0.450	-0.67 Number of Catheterizations Per Day Standard Error 0.924	-0.36 Number of Catheterizations Per Day Standard Error 0.791

Adverse Events

DB: Placebo (Pre-Amend 3)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

DB: OTG (Pre-Amend 3)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

OL: OTG (Pre-Amend 3)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

OL: OTG (Post-Amend 3)

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DB: Placebo (Pre-Amend 3) n=16 participants at risk Subjects were randomized to receive Double-Blind (DB) placebo gel for 6 weeks. Followed by: OL oxybutynin chloride gel (OTG) for 8-week period to generate additional safety data.	DB: OTG (Pre-Amend 3) n=17 participants at risk Subjects were randomized to receive DB oxybutynin chloride gel (OTG) for 6 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day. Followed by: OL OG for 8-week period to generate additional safety data.	OL: OTG (Pre-Amend 3) n=33 participants at risk Subjects received Open-Label (OL) oxybutynin chloride gel (OTG) for 8 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day.	OL: OTG (Post-Amend 3) n=19 participants at risk Subjects received OL oxybutynin chloride gel (OTG) for 14 weeks. All subjects began treatment with 0.75 g of gel/day for 2 weeks. The dose of OTG was adjusted to obtain the optimal clinical response. The dose titration of OTG could be adjusted up to 1 g/day, down to 0.5 g/day, or remain the same at 0.75 g/day
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/16 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/17 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	3.0% 1/33 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/19 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.
Infections and infestations PYELONEPHRITIS	0.00% 0/16 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/17 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	3.0% 1/33 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/19 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/16 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/17 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	3.0% 1/33 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/19 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.
Infections and infestations UROSEPSIS	0.00% 0/16 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/17 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/33 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	5.3% 1/19 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.
Musculoskeletal and connective tissue disorders LIMB DEFORMITY	0.00% 0/16 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/17 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/33 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	5.3% 1/19 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.
Product Issues DEVICE MALFUNCTION	0.00% 0/16 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/17 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	0.00% 0/33 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.	10.5% 2/19 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up was 42.0,43.0, 57.0, and 99.0 days for DB: Placebo (Pre-Amend 3), DB: OTG (Pre-Amend 3) OL: OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 2 weeks after the last dose of study drug; mean duration on study drug was 42.1, 56.0, and 96.6 days for DB: Placebo (Pre-Amend 3), OTG (Pre-Amend 3), and OL: OTG (Post-Amend 3) , respectively.

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