Trial Outcomes & Findings for Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) (NCT NCT01229436)

NCT ID: NCT01229436

Last Updated: 2014-03-17

Results Overview

TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 254 participants
• Primary outcome timeframe: Baseline for first injection
• Results posted on: 2014-03-17

Participant Flow

Participant milestones

Measure	Xiapex A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Study STARTED	254
Overall Study COMPLETED	249
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Xiapex A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	3

Baseline Characteristics

Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)

Baseline characteristics by cohort

Measure	Xiapex n=254 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Age, Continuous	60.2 years STANDARD_DEVIATION 7.37 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	223 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline for first injection

Population: Full analysis set(FAS):participants who received at least (\>=)1 injection of Xiapex,had \>=1 post-injection efficacy assessment(goniometric/participant-reported). 'N'(number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=259 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Baseline for First Injection

55.0 degrees Interval 2.0 to 180.0

PRIMARY outcome

Timeframe: Baseline for second injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=65 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Baseline for Second Injection

45.0 degrees Interval 15.0 to 145.0

PRIMARY outcome

Timeframe: Baseline for third injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=21 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Baseline for Third Injection

40.0 degrees Interval 0.0 to 80.0

PRIMARY outcome

Timeframe: Baseline for fourth injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=1 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection

20.0 degrees Interval 20.0 to 20.0

PRIMARY outcome

Timeframe: Day 1 after first injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=256 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 1 After First Injection

20.0 degrees Interval 0.0 to 165.0

PRIMARY outcome

Timeframe: Day 7 after first injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=256 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 7 After First Injection

10.0 degrees Interval 0.0 to 110.0

PRIMARY outcome

Timeframe: Day 30 after first injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=257 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 30 After First Injection

10.0 degrees Interval 0.0 to 110.0

PRIMARY outcome

Timeframe: Day 1 after second injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=64 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 1 After Second Injection

29.0 degrees Interval 0.0 to 145.0

PRIMARY outcome

Timeframe: Day 7 after second injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=65 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 7 After Second Injection

20.0 degrees Interval 0.0 to 155.0

PRIMARY outcome

Timeframe: Day 30 after second injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=64 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 30 After Second Injection

20.0 degrees Interval 0.0 to 145.0

PRIMARY outcome

Timeframe: Day 1 after third injection

Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=19 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 1 After Third Injection

15.0 degrees Interval 0.0 to 70.0

PRIMARY outcome

Timeframe: Day 7 after third injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=21 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 7 After Third Injection

22.0 degrees Interval 0.0 to 80.0

PRIMARY outcome

Timeframe: Day 30 after third injection

Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=21 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 30 After Third Injection

30.0 degrees Interval 0.0 to 80.0

PRIMARY outcome

Timeframe: Day 1 after fourth injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=1 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection

0.0 degrees Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Day 7 after fourth injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=1 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection

0.0 degrees Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Day 30 after fourth injection

Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=1 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection

10.0 degrees Interval 10.0 to 10.0

PRIMARY outcome

Timeframe: Day 90 after last injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=244 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 90 After Last Injection

10.0 degrees Interval 0.0 to 120.0

PRIMARY outcome

Timeframe: Day 180 after last injection

Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure

Xiapex n=250 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Total Passive Extension Deficit (TPED) at Day 180 After Last Injection

14.5 degrees Interval 0.0 to 195.0

SECONDARY outcome

Timeframe: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.

Outcome measures

Measure	Xiapex n=309 Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for first injection: MP Joint (n=211)	40.0 degrees Interval 0.0 to 90.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after first injection: MP Joint (n=207)	8.0 degrees Interval 0.0 to 80.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after first injection: MP Joint (n=209)	0.0 degrees Interval 0.0 to 82.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after first injection: MP Joint (n=209)	0.0 degrees Interval 0.0 to 70.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for second injection: MP Joint (n=33)	25.0 degrees Interval 0.0 to 74.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after second injection: MP Joint (n=33)	5.0 degrees Interval 0.0 to 45.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after second injection: MP Joint (n=33)	5.0 degrees Interval 0.0 to 50.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after second injection: MP Joint (n=32)	8.5 degrees Interval 0.0 to 30.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for third injection: MP Joint (n=9)	20.0 degrees Interval 0.0 to 50.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after third injection: MP Joint (n=9)	0.0 degrees Interval 0.0 to 50.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after third injection: MP Joint (n=9)	10.0 degrees Interval 0.0 to 40.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after third injection: MP Joint (n=9)	20.0 degrees Interval 0.0 to 40.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for follow-up: MP Joint (n=201)	40.0 degrees Interval 0.0 to 90.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Follow-up Day 90: MP Joint (n=201)	0.0 degrees Interval 0.0 to 70.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Follow-up Day 180: MP Joint (n=207)	0.0 degrees Interval 0.0 to 85.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for first injection: PIP Joint (n=98)	45.0 degrees Interval 15.0 to 94.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after first injection: PIP Joint (n=98)	20.0 degrees Interval 0.0 to 80.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after first injection: PIP Joint (n=97)	14.0 degrees Interval 0.0 to 90.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after first injection: PIP Joint (n=98)	18.5 degrees Interval 0.0 to 90.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for second injection: PIP Joint (n=18)	40.0 degrees Interval 5.0 to 90.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after second injection: PIP Joint (n=15)	30.0 degrees Interval 0.0 to 90.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after second injection: PIP Joint (n=18)	30.0 degrees Interval 0.0 to 90.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after second injection: PIP Joint (n=18)	27.0 degrees Interval 0.0 to 95.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for third injection: PIP Joint (n=6)	37.5 degrees Interval 20.0 to 80.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after third injection: PIP Joint (n=6)	12.5 degrees Interval 0.0 to 70.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after third injection: PIP Joint (n=6)	17.5 degrees Interval 0.0 to 80.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after third injection: PIP Joint (n=6)	20.0 degrees Interval 5.0 to 80.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for follow-up: PIP Joint (n=93)	45.0 degrees Interval 15.0 to 94.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Follow-up Day 90: PIP Joint (n=93)	20.0 degrees Interval 0.0 to 80.0
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Follow-up Day 180: PIP Joint (n=93)	25.0 degrees Interval 0.0 to 80.0

SECONDARY outcome

Timeframe: Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection

Population: FAS population. 'N' (number of participants analyzed) includes total number of participants in FAS,however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. Here, 'n' signifies number of fingers/joints evaluable for this outcome measure at given time points.

TPED was defined as sum of PED in MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was TPED value taken closest and prior to administration of that particular injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). Change in TPED was reported at Day 1, 7 and 30 after each injection for fingers that received 1 through 4 injections and at Day 90, 180 after last injection, where last injection was a maximum up to fourth injection for a finger. Results are not reported for fifth injection as no finger received 5 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

Outcome measures

Measure	Xiapex n=257 Fingers/Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 1 after first injection (n=256)	-31.0 degrees Interval -145.0 to 35.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 7 after first injection (n=256)	-40.0 degrees Interval -160.0 to 15.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 30 after first injection (n=257)	-40.0 degrees Interval -155.0 to 7.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 1 after second injection (n=64)	-20.0 degrees Interval -85.0 to 33.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 7 after second injection (n=65)	-20.0 degrees Interval -85.0 to 31.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 30 after second injection (n=64)	-20.0 degrees Interval -89.0 to 31.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 1 after third injection (n=19)	-15.0 degrees Interval -45.0 to 3.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 7 after third injection (n=21)	-10.0 degrees Interval -45.0 to 20.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 30 after third injection (n=21)	-10.0 degrees Interval -20.0 to 20.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 1 after fourth injection (n=1)	-20.0 degrees Interval -20.0 to -20.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 7 after fourth injection (n=1)	-20.0 degrees Interval -20.0 to -20.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Day 30 after fourth injection (n=1)	-10.0 degrees Interval -10.0 to -10.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Follow-up Day 90 (n=244)	-40.0 degrees Interval -155.0 to 25.0
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection Change at Follow-up Day 180 (n=250)	-35.0 degrees Interval -165.0 to 50.0

SECONDARY outcome

Timeframe: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. Change in PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.

Outcome measures

Measure	Xiapex n=307 Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Follow-up Day 90: MP(n=201)	-35.0 degrees Interval -88.0 to 10.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Follow-up Day 180: MP(n=207)	-35.0 degrees Interval -82.0 to 20.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 1 after first injection: PIP(n=98)	-25.0 degrees Interval -90.0 to 33.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 7 after first injection: PIP(n=97)	-30.0 degrees Interval -90.0 to 31.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 30 after first injection: PIP(n=98)	-30.0 degrees Interval -94.0 to 31.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 1 after second injection: PIP(n=15)	-10.0 degrees Interval -42.0 to 6.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 7 after second injection: PIP(n=18)	-12.5 degrees Interval -45.0 to 6.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 30 after second injection: PIP(n=18)	-14.5 degrees Interval -40.0 to 10.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 1 after third injection: PIP(n=6)	-20.0 degrees Interval -30.0 to 0.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 7 after third injection: PIP(n=6)	-16.5 degrees Interval -35.0 to 0.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 30 after third injection: PIP(n=6)	-15.0 degrees Interval -20.0 to 0.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Follow-up Day 90: PIP(n=93)	-20.0 degrees Interval -90.0 to 25.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Follow-up Day 180: PIP(n=93)	-20.0 degrees Interval -94.0 to 25.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 1 after first injection: MP(n=207)	-30.0 degrees Interval -90.0 to 25.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 7 after first injection: MP(n=209)	-30.0 degrees Interval -80.0 to 12.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 30 after first injection: MP(n=209)	-35.0 degrees Interval -80.0 to 10.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 1 after second injection: MP(n=33)	-20.0 degrees Interval -60.0 to 10.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 7 after second injection: MP(n=33)	-20.0 degrees Interval -58.0 to 20.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 30 after second injection: MP(n=32)	-20.0 degrees Interval -68.0 to 10.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 1 after third injection: MP(n=9)	-10.0 degrees Interval -30.0 to 0.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 7 after third injection: MP(n=9)	-10.0 degrees Interval -30.0 to 10.0
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection Change at Day 30 after third injection: MP(n=9)	-10.0 degrees Interval -10.0 to 10.0

SECONDARY outcome

Timeframe: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection

Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

Finger goniometry was used to measure the angles of extension and flexion of MP and PIP joints. ROM was measured as the difference between the angle of flexion and the angle of extension of the joint. For each injection, baseline value was the ROM value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the ROM value taken closest and prior to administration of first injection in that joint. ROM was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.

Outcome measures

Measure	Xiapex n=307 Joints A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for first injection: MP Joint (n=208)	45.0 degrees Interval 0.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after first injection: MP Joint (n=207)	65.0 degrees Interval 10.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after first injection: MP Joint (n=209)	80.0 degrees Interval -42.0 to 105.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after first injection: MP Joint (n=209)	86.0 degrees Interval 20.0 to 105.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for second injection: MP Joint (n=33)	60.0 degrees Interval 10.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after second injection: MP Joint (n=33)	76.0 degrees Interval 20.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after second injection: MP Joint (n=32)	80.0 degrees Interval 6.0 to 95.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after second injection: MP Joint (n=32)	80.0 degrees Interval 28.0 to 95.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for third injection: MP Joint (n=9)	70.0 degrees Interval 40.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after third injection: MP Joint (n=9)	90.0 degrees Interval 40.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after third injection: MP Joint (n=9)	80.0 degrees Interval 45.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after third injection: MP Joint (n=9)	70.0 degrees Interval 50.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for follow-up: MP Joint (n=198)	45.0 degrees Interval 0.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Follow-up Day 90: MP Joint (n=201)	90.0 degrees Interval 20.0 to 110.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Follow-up Day 180: MP Joint (n=207)	90.0 degrees Interval 10.0 to 110.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for first injection: PIP Joint (n=98)	50.0 degrees Interval 0.0 to 85.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after first injection: PIP Joint (n=98)	63.0 degrees Interval 10.0 to 100.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after first injection: PIP Joint (n=97)	75.0 degrees Interval 10.0 to 110.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after first injection: PIP Joint (n=98)	75.5 degrees Interval 10.0 to 105.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for second injection: PIP Joint (n=18)	50.0 degrees Interval 10.0 to 85.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after second injection: PIP Joint (n=15)	50.0 degrees Interval 10.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after second injection: PIP Joint (n=18)	67.0 degrees Interval 20.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after second injection: PIP Joint (n=18)	65.0 degrees Interval 10.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for third injection: PIP Joint (n=6)	57.5 degrees Interval 10.0 to 70.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 1 after third injection: PIP Joint (n=6)	80.0 degrees Interval 20.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 7 after third injection: PIP Joint (n=6)	80.0 degrees Interval 10.0 to 90.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Day 30 after third injection: PIP Joint (n=6)	72.5 degrees Interval 10.0 to 85.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Baseline for follow-up: PIP Joint (n=93)	50.0 degrees Interval 0.0 to 85.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Follow-up Day 90: PIP Joint (n=93)	72.0 degrees Interval 10.0 to 105.0
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints Follow-up Day 180: PIP Joint (n=93)	70.0 degrees Interval 10.0 to 105.0

SECONDARY outcome

Timeframe: Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection

Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.

Participant global assessment questionnaire assessed severity of the contracture at baseline, post-injection and treatment satisfaction (TS), improvement from baseline in the treated contracture at post-injection only. Participants rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Participants rated their improvement in disease severity relative to baseline on a 11-point scale ranging from 0 percent (%) = no improvement to 100% = total recovery, with 10 % increment between each point. Results are reported for number of participants in each category for disease severity, TS and improvement.

Outcome measures

Measure	Xiapex n=254 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 1, severity: normal (n=254)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 1, severity: mild (n=254)	40 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 1, severity: moderate (n=254)	128 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 1, severity: severe (n=254)	84 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, severity: normal (n=253)	63 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, severity: mild (n=253)	114 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, severity: moderate (n=253)	55 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, severity: severe (n=253)	21 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, TS: very satisfied (n=253)	153 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, TS: satisfied (n=253)	73 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, TS: neither satisfied/dissatisfied (n=253)	16 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, TS: dissatisfied (n=253)	6 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, TS: very dissatisfied (n=253)	5 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 0% (n=252)	10 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 10% (n=252)	11 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 20% (n=252)	6 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 30% (n=252)	8 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 40% (n=252)	6 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 50% (n=252)	20 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 60% (n=252)	15 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 70% (n=252)	19 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 80% (n=252)	52 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 90% (n=252)	58 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: 100% (n=252)	47 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 2, severity: mild (n=112)	22 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 2, severity: moderate (n=112)	62 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 2, severity: severe (n=112)	28 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, severity: normal (n=109)	27 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, severity: mild (n=109)	47 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, severity: moderate (n=109)	24 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, severity: severe (n=109)	11 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, TS: very satisfied (n=109)	64 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, TS: satisfied (n=109)	37 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, TS: neither satisfied/dissatisfied (n=109)	6 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, TS: dissatisfied (n=109)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, TS: very dissatisfied (n=109)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 0% (n=109)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 10% (n=109)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 20% (n=109)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 30% (n=109)	7 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 40% (n=109)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 50% (n=109)	10 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 60% (n=109)	9 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 70% (n=109)	8 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 80% (n=109)	13 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 90% (n=109)	33 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement: 100% (n=109)	18 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 3, severity: normal (n=54)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 3, severity: mild (n=54)	14 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 3, severity: moderate (n=54)	25 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 3, severity: severe (n=54)	14 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, severity: normal (n=54)	8 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, severity: mild (n=54)	26 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, severity: moderate (n=54)	16 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, severity: severe (n=54)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, TS: very satisfied (n=54)	29 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, TS: satisfied (n=54)	18 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, TS: neither satisfied/dissatisfied (n=54)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, TS: dissatisfied (n=54)	3 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: 0% (n=54)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: 10% (n=54)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: 20% (n=54)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: 30% (n=54)	3 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: 40% (n=54)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: 60% (n=54)	7 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: 70% (n=54)	11 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: 80% (n=54)	8 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: 90% (n=54)	16 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: 100% (n=54)	3 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 4, severity: mild (n=24)	11 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 4, severity: moderate (n=24)	9 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 4, severity: severe (n=24)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, severity: normal (n=24)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, severity: mild (n=24)	13 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, severity: moderate (n=24)	8 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, severity: severe (n=24)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, TS: very satisfied (n=24)	13 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, TS: satisfied (n=24)	9 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, TS: dissatisfied (n=24)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: 10% (n=24)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: 20% (n=24)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: 40% (n=24)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: 50% (n=24)	3 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: 60% (n=24)	3 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: 70% (n=24)	3 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: 80% (n=24)	5 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: 90% (n=24)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: 100% (n=24)	3 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 5, severity: mild (n=12)	7 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 5, severity: moderate (n=12)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 5, severity: severe (n=12)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, severity: normal (n= 12)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, severity: mild (n= 12)	6 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, severity: moderate (n= 12)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, severity: severe (n= 12)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, TS: very satisfied (n= 12)	8 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, TS: satisfied (n= 12)	3 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, TS: neither satisfied/dissatisfied (n= 12)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, improvement: 10% (n= 12)	1 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, improvement: 70% (n= 12)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, improvement: 80% (n= 12)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity C5D30, improvement: 90% (n= 12)	5 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, severity: normal (n=246)	92 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, severity: mild (n=246)	102 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, severity: moderate (n=246)	43 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, severity: severe (n=246)	9 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, TS: very satisfied (n=247)	163 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, TS: satisfied (n=247)	57 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90,TS:neither satisfied/dissatisfied(n=247)	10 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, TS: satisfaction: dissatisfied (n=247)	13 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, TS:very dissatisfied (n=247)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 0% (n=247)	7 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 10% (n=247)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 20% (n=247)	6 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 30% (n=247)	3 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 40% (n=247)	6 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 50% (n=247)	13 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 60% (n=247)	5 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 70% (n=247)	20 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 80% (n=247)	42 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 90% (n=247)	78 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: 100% (n=247)	63 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, severity: normal (n=248)	78 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, severity: mild (n=248)	96 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, severity: moderate (n=248)	54 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, severity: severe (n=248)	20 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, TS: very satisfied (n=249)	152 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, TS: satisfied (n=249)	64 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day180,TS:neither satisfied/dissatisfied(n=249)	13 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180,TS: dissatisfied (n=249)	15 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180,TS: very dissatisfied (n=249)	5 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 0% (n=249)	17 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 10% (n=249)	5 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 20% (n=249)	2 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 50% (n=249)	15 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 30% (n=249)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 40% (n=249)	4 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 60% (n=249)	6 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 70% (n=249)	21 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 80% (n=249)	43 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 90% (n=249)	74 participants
Participant Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: 100% (n=249)	58 participants

SECONDARY outcome

Timeframe: Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection

Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.

Physician global assessment questionnaire assessed severity of the contracture at baseline, post-injection and TS, improvement from baseline in the treated contracture at post-injection only. Physician's rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Physicians rated participant's improvement in disease severity relative to baseline as very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse.

Outcome measures

Measure	Xiapex n=254 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, TS: satisfied (n=250)	90 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, TS: neither satisfied/dissatisfied (n=250)	14 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, TS: dissatisfied (n=250)	7 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, TS: very dissatisfied (n=250)	5 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: very much improved (n=250)	121 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: much improved (n=250)	88 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: minimally improved (n=250)	26 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: no change (n=250)	14 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, improvement: minimally worse (n=250)	1 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 2, severity: mild (n=110)	33 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 2, severity: moderate (n=110)	53 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 2, severity: severe (n=110)	24 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, severity: normal (n=108)	20 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, severity: mild (n=108)	51 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, severity: moderate (n=108)	28 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 1, severity: mild (n=254)	51 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 1, severity: moderate (n=254)	138 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 1, severity: severe (n=254)	65 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, severity: normal (n=250)	60 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, severity: mild (n=250)	106 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, severity: moderate (n=250)	62 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, severity: severe (n=250)	22 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C1D30, TS: very satisfied (n=250)	134 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 3, severity: severe (n=53)	12 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, severity: normal (n=53)	9 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, severity: mild (n=53)	24 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, severity: moderate (n=53)	13 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, severity: severe (n=53)	7 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, TS: very satisfied (n=53)	26 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, TS: satisfied (n=53)	22 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, TS: neither satisfied/dissatisfied (n=53)	4 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, TS: dissatisfied (n=53)	1 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: very much improved (n=53)	22 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: much improved (n=53)	24 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: minimally improved (n=53)	5 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C3D30, improvement: no change (n=53)	2 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 4, severity: mild (n=24)	10 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 4, severity: moderate (n=24)	9 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, severity: severe (n=108)	9 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, severity: mild (n=24)	11 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, TS: very satisfied (n=108)	63 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, TS: satisfied (n=108)	36 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, TS: neither satisfied/dissatisfied (n=108)	5 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 4, severity: severe (n=24)	5 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, severity: normal (n=24)	2 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, severity: moderate (n=24)	8 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, severity: severe (n=24)	3 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, TS: very satisfied (n=24)	4 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, TS: satisfied (n=24)	15 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, TS: neither satisfied/dissatisfied (n=24)	1 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, TS: dissatisfied (n=24)	1 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, TS: dissatisfied (n=108)	3 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, TS: very dissatisfied (n=108)	1 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30,improvement:very much improved (n=108)	41 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement:much improved (n=108)	55 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement:minimally improved (n=108)	8 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C2D30, improvement:no change (n=108)	4 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 3, severity: mild (n=53)	16 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 3, severity: moderate (n=53)	25 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: very much improved (n=24)	6 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: much improved (n=24)	14 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: minimally improved (n=24)	3 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C4D30, improvement: no change (n=24)	1 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 5, severity: mild (n=12)	5 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 5, severity: moderate (n=12)	5 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity Baseline for cycle 5, severity: severe (n=12)	2 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C5D30, severity: mild (n= 12)	7 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C5D30, severity: moderate (n= 12)	3 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C5D30, severity: severe (n= 12)	2 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C5D30, TS: very satisfied (n= 12)	7 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C5D30, TS: satisfied (n= 12)	3 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C5D30, TS: neither satisfied/dissatisfied (n= 12)	2 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C5D30, improvement: very much improved (n=12)	5 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C5D30, improvement: much improved (n=12)	5 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C5D30, improvement: minimally improved (n=12)	1 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity C5D30, improvement: no change (n=12)	1 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, severity: normal (n=247)	70 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, severity: mild (n=247)	117 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, severity: moderate (n=247)	51 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, severity: severe (n=247)	9 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, TS: very satisfied (n=247)	145 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, TS: satisfied (n=247)	75 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90,TS:neither satisfied/dissatisfied(n=247)	15 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, TS: dissatisfied (n=247)	10 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, TS: very dissatisfied (n=247)	2 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: very much improved (n=247)	123 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: much improved (n=247)	95 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: minimally improved (n=247)	17 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: no change (n=247)	11 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 90, improvement: much worse (n=247)	1 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, severity: normal (n=249)	67 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, severity: mild (n=249)	114 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, severity: moderate (n=249)	47 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, severity: severe (n=249)	21 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, TS: very satisfied (n=249)	117 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, TS: satisfied (n=249)	97 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day180,TS:neither satisfied/dissatisfied(n=249)	15 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, TS: dissatisfied (n=249)	12 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, TS: very dissatisfied(n=249)	8 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement:very much improved(n=249)	94 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: much improved (n=249)	114 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement:minimally improved(n=249)	18 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement:no change (n=249)	13 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: minimally worse (n=249)	5 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: much worse (n=249)	4 participants
Physician Global Assessment of Treatment Satisfaction and Disease Severity FU Day 180, improvement: very much worse (n=249)	1 participants

SECONDARY outcome

Timeframe: Screening up to Day 180 after last injection

Population: Safety set included all participants who received at least 1 injection of Xiapex.

Number of participants who took different types of analgesic medications, including acetylsalicylic acid, other analgesics (any other analgesic besides those mentioned, as approved by the investigator), aporex, codis, dihydrocodeine, fentanyl, galenic/paracetamol/codeine/, hot coldrex, metamizole, morphine, oxycodone, panadeine CO (combination of paracetamol and codeine phosphate), paracetamol, paramol-118, pregabalin, solpadeine, tramadol, ultracet, to manage pain symptoms were reported. A single participant may be represented in more than 1 category.

Outcome measures

Measure	Xiapex n=254 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Number of Participants With Type of Concomitant Pain Medication Used Acetylsalicylic acid	5 participants
Number of Participants With Type of Concomitant Pain Medication Used Other analgesics	2 participants
Number of Participants With Type of Concomitant Pain Medication Used Aporex	1 participants
Number of Participants With Type of Concomitant Pain Medication Used Codis	1 participants
Number of Participants With Type of Concomitant Pain Medication Used Dihydrocodeine	1 participants
Number of Participants With Type of Concomitant Pain Medication Used Fentanyl	3 participants
Number of Participants With Type of Concomitant Pain Medication Used Galenic/Paracetamol/Codeine	2 participants
Number of Participants With Type of Concomitant Pain Medication Used Hot coldrex	1 participants
Number of Participants With Type of Concomitant Pain Medication Used Metamizole	4 participants
Number of Participants With Type of Concomitant Pain Medication Used Morphine	3 participants
Number of Participants With Type of Concomitant Pain Medication Used Oxycodone	1 participants
Number of Participants With Type of Concomitant Pain Medication Used Panadeine CO	11 participants
Number of Participants With Type of Concomitant Pain Medication Used Paracetamol	96 participants
Number of Participants With Type of Concomitant Pain Medication Used Paramol-118	1 participants
Number of Participants With Type of Concomitant Pain Medication Used Pregabalin	2 participants
Number of Participants With Type of Concomitant Pain Medication Used Solpadeine	1 participants
Number of Participants With Type of Concomitant Pain Medication Used Tramadol	7 participants
Number of Participants With Type of Concomitant Pain Medication Used Ultracet	2 participants

SECONDARY outcome

Timeframe: Screening up to Day 180 after last injection

Population: Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure.

Amount of concomitant pain medication was assessed as the number of days participants used pain medication during the study.

Outcome measures

Measure

Xiapex n=136 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Number of Days of Concomitant Pain Medication Usage

2.0 days Interval 1.0 to 340.0

SECONDARY outcome

Timeframe: C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30

Population: FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.

Dupuytren's daily diary questionnaire assessed number of days during a cycle when 1) participant was absent or sick due to treatment, 2) the work hours were reduced, 3) the job duties were modified, 4) participant was unable to participate in hobbies and 5) participant wore a splint (for participants who were fitted for a splint).

Outcome measures

Measure	Xiapex n=230 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C1D1 to C1D30: Absent or on sick leave (n=230)	3.0 days Full Range 3.80 • Interval 1.0 to 16.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C1D1 to C1D30: Reduced work hours (n=230)	2.0 days Full Range 3.43 • Interval 1.0 to 16.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C1D1 to C1D30: Modified job duties (n=230)	2.0 days Full Range 3.62 • Interval 1.0 to 16.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C1D1 to C1D30: Not participated in hobbies (n=230)	5.0 days Full Range 4.61 • Interval 1.0 to 16.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C1D1 to C1D30: Fitted with splint (n=211)	12.0 days Full Range 3.91 • Interval 1.0 to 16.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C2D1 to C2D30: Absent or on sick leave (n=103)	3.0 days Full Range 3.33 • Interval 1.0 to 13.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C2D1 to C2D30: Reduced work hours (n=103)	2.0 days Full Range 3.11 • Interval 1.0 to 12.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C2D1 to C2D30: Modified job duties (n=103)	2.0 days Full Range 3.41 • Interval 1.0 to 12.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C2D1 to C2D30: Not participated in hobbies (n=103)	5.0 days Full Range 4.61 • Interval 1.0 to 15.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C2D1 to C2D30: Fitted with splint (n=96)	11.0 days Full Range 4.28 • Interval 1.0 to 16.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C3D1 to C3D30: Absent or on sick leave (n=51)	2.0 days Full Range 4.53 • Interval 1.0 to 15.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C3D1 to C3D30: Reduced work hours (n=51)	3.0 days Full Range 4.53 • Interval 1.0 to 14.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C3D1 to C3D30: Modified job duties (n=51)	3.0 days Full Range 4.83 • Interval 1.0 to 14.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C3D1 to C3D30: Not participated in hobbies (n=51)	3.0 days Full Range 5.05 • Interval 1.0 to 15.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C3D1 to C3D30: Fitted with splint (n=44)	10.0 days Full Range 4.20 • Interval 1.0 to 15.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C4D1 to C4D30: Absent or on sick leave (n=19)	2.5 days Full Range 3.61 • Interval 2.0 to 11.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C4D1 to C4D30: Reduced work hours (n=19)	2.0 days Full Range 2.51 • Interval 1.0 to 7.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C4D1 to C4D30: Modified job duties (n=19)	2.0 days Full Range 2.25 • Interval 1.0 to 7.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C4D1 to C4D30: Not participated in hobbies (n=19)	2.0 days Full Range 3.75 • Interval 1.0 to 11.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C4D1 to C4D30: Fitted with splint (n=15)	10.5 days Full Range 4.11 • Interval 4.0 to 16.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C5D1 to C5D30: Absent or on sick leave (n=6)	8.5 days Full Range 4.95 • Interval 5.0 to 12.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C5D1 to C5D30: Reduced work hours (n=6)	8.5 days Full Range 10.61 • Interval 1.0 to 16.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C5D1 to C5D30: Modified job duties (n=6)	10.5 days Full Range 7.78 • Interval 5.0 to 16.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C5D1 to C5D30: Not participated in hobbies (n=6)	13.0 days Full Range 6.22 • Interval 2.0 to 16.0
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire C5D1 to C5D30: Fitted with splint (n=5)	11.0 days Full Range 5.94 • Interval 1.0 to 16.0

SECONDARY outcome

Timeframe: Up to Day 30 after first, second and third injection

Population: FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.

Time to recovery of normal activities was defined as median number of days between the initial injection date and the date on which participant recovered to normal activities, assessed after first, second and third injection for joints that received 1 through 3 injections. If a participant did not achieve recovery to normal activities, the participant's time to recovery was defined as the median number of days between the initial injection date and the date of the participant's the last daily diary recording within the cycle.

Outcome measures

Measure	Xiapex n=230 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Time to Recovery First injection (n=230)	3.0 days Interval 3.0 to 4.0
Time to Recovery Second injection (n=103)	4.0 days Interval 2.0 to 5.0
Time to Recovery Third injection (n=51)	3.0 days Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection

Population: FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.

URAM:9-item questionnaire used to assess daily hand functionality.Participants rated their ability to perform following hand functionalities on 0 to 5 scale(0=without difficulty,5=impossible):1)washing themselves with flannel, keeping hand flat,2)washing face,3)holding bottle in one hand,4)shaking someone's hand,5)stroking/caressing someone,6)clapping,7)spreading out fingers, 8)leaning on hand,9)picking up small objects with thumb and index finger.URAM total score=sum of 9 items.Total score range=0 to 45,where higher score= higher difficulty in daily hand functionality.For each cycle, baseline value=pre-injection value reported at that cycle. For follow-up on Day 90,180 after last injection, baseline value (follow-up baseline)=pre-injection value reported at cycle 1. If response was provided to less than or equal to 4 items,URAM total score was considered missing. If response was provided to >=5 items, then average score of answered questions was imputed response to missing questions.

Outcome measures

Measure	Xiapex n=126 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score Baseline for cycle 1 (n=85)	13.0 units on a scale Interval 0.0 to 32.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score C1D30 (n=89)	3.0 units on a scale Interval 0.0 to 29.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score Baseline for cycle 2 (n=47)	7.0 units on a scale Interval 0.0 to 36.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score C2D30 (n=51)	4.0 units on a scale Interval 0.0 to 36.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score Baseline for cycle 3 (n=31)	8.0 units on a scale Interval 0.0 to 36.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score C3D30 (n=31)	3.0 units on a scale Interval 0.0 to 32.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score Baseline for cycle 4 (n=15)	6.0 units on a scale Interval 0.0 to 32.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score C4D30 (n=15)	5.6 units on a scale Interval 0.0 to 32.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score Baseline for cycle 5 (n=9)	9.0 units on a scale Interval 0.0 to 32.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score C5D30 (n=9)	2.3 units on a scale Interval 0.0 to 28.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score Baseline for Follow-up Day 90 (n=82)	13.0 units on a scale Interval 0.0 to 32.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score Follow-up Day 90 (n=108)	1.0 units on a scale Interval 0.0 to 29.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score Baseline for Follow-up Day 180 (n=83)	13.0 units on a scale Interval 0.0 to 32.0
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score Follow-up Day 180 (n=126)	0.5 units on a scale Interval 0.0 to 38.0

SECONDARY outcome

Timeframe: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection

Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.

Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered whether or not since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed, 7) were admitted in nursing home, 8) required aids/devices to assist in their daily functioning.

Outcome measures

Measure	Xiapex n=254 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Seen any doctor (n=254)	10 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Received any therapy (n=254)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1:Treated in emergency room(n=254)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Outpatient surgery (n=254)	2 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Hospitalization (n=254)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Diagnostic test (n=254)	2 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: In nursing home (n=254)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Required aids/devices (n=254)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Seen any doctor (n=252)	21 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Received any therapy (n=252)	12 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Treated in emergency room (n=252)	4 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Outpatient surgery (n=252)	9 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Hospitalization (n=252)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Diagnostic test (n=252)	2 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: In nursing home (n=252)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Required aids/devices (n=252)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Seen any doctor (n=251)	14 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Received any therapy (n=251)	7 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Treated in emergency room (n=251)	2 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Outpatient surgery (n=251)	3 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Hospitalization (n=251)	2 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Diagnostic test (n=251)	4 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: In nursing home (n=251)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Required aids/devices (n=251)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: Seen any doctor (n=111)	4 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: Received any therapy (n=111)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2:Treated in emergency room(n=111)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: Outpatient surgery (n=111)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: Hospitalization (n=111)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: Diagnostic test (n=111)	2 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: In nursing home (n=111)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: Required aids/devices (n=111)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Seen any doctor (n=112)	4 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Received any therapy (n=112)	4 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Treated in emergency room (n=112)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Outpatient surgery (n=112)	3 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Hospitalization (n=112)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Diagnostic test (n=112)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: In nursing home (n=112)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Required aids/devices (n=112)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Seen any doctor (n=111)	5 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Received any therapy (n=111)	3 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Treated in emergency room (n=111)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Outpatient surgery (n=111)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Hospitalization (n=111)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Diagnostic test (n=111)	2 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: In nursing home (n=111)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Required aids/devices (n=111)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 3: Seen any doctor (n=51)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 3: Received any therapy (n=51)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 3:Treated in emergency room(n=51)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 3: Outpatient surgery (n=51)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 3: Hospitalization (n=51)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 3: Diagnostic test (n=51)	2 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 3: In nursing home (n=51)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 3: Required aids/devices (n=51)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D7: Seen any doctor (n=54)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D7: Received any therapy (n=54)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D7: Treated in emergency room (n=54)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D7: Outpatient surgery (n=54)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D7: Hospitalization (n=54)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D7: Diagnostic test (n=54)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D7: In nursing home (n=54)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D7: Required aids/devices (n=54)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Seen any doctor (n=54)	2 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Received any therapy (n=54)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Treated in emergency room (n=54)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Outpatient surgery (n=54)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Hospitalization (n=54)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Diagnostic test (n=54)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: In nursing home (n=54)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Required aids/devices (n=54)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 4: Seen any doctor (n=23)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 4: Received any therapy (n=23)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 4:Treated in emergency room(n=23)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 4: Outpatient surgery (n=23)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 4: Hospitalization (n=23)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 4: Diagnostic test (n=23)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 4: In nursing home (n=23)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 4: Required aids/devices (n=23)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D7: Seen any doctor (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D7: Received any therapy (n=24)	2 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D7: Treated in emergency room (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D7: Outpatient surgery (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D7: Hospitalization (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D7: Diagnostic test (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D7: In nursing home (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D7: Required aids/devices (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D30: Seen any doctor (n=24)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D30: Received any therapy (n=24)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D30: Treated in emergency room (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D30: Outpatient surgery (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D30: Hospitalization (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D30: Diagnostic test (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D30: In nursing home (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D30: Required aids/devices (n=24)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 5: Seen any doctor (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 5: Received any therapy (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 5:Treated in emergency room(n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 5: Outpatient surgery (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 5: Hospitalization (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 5: Diagnostic test (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 5: In nursing home (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 5: Required aids/devices (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D7: Seen any doctor (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D7: Received any therapy (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D7: Treated in emergency room (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D7: Outpatient surgery (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D7: Hospitalization (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D7: Diagnostic test (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D7: In nursing home (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D7: Required aids/devices (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D30: Seen any doctor (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D30: Received any therapy (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D30: Treated in emergency room (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D30: Outpatient surgery (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D30: Hospitalization (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D30: Diagnostic test (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D30: In nursing home (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C5D30: Required aids/devices (n=12)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Seen any doctor (n=247)	10 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Received any therapy (n=247)	8 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90:Treated in emergency room(n=247)	8 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Outpatient surgery (n=247)	11 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Hospitalization (n=247)	4 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Diagnostic test (n=247)	4 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: In nursing home (n=247)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90:Required aids/devices(n=247)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Seen any doctor (n=249)	4 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Received any therapy (n=249)	3 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180:Treated in emergency room(n=249)	8 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Outpatient surgery (n=249)	9 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Hospitalization (n=248)	6 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Diagnostic test (n=247)	1 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: In nursing home (n=248)	0 participants
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Required aids/devices (n=248)	3 participants

SECONDARY outcome

Timeframe: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection

Population: FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of events was not analyzed for participants who responded that they did not perform the event.

Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many times since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed.

Outcome measures

Measure	Xiapex n=21 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Hospitalization (n=1)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Seen any doctor (n=10)	1.0 events Interval 1.0 to 2.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Treated in emergency room (n=1)	2.0 events Interval 2.0 to 2.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Outpatient surgery (n=2)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Diagnostic test (n=2)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Seen any doctor (n=21)	1.0 events Interval 1.0 to 3.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Received any therapy (n=12)	1.0 events Interval 1.0 to 6.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Treated in emergency room (n=4)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Outpatient surgery (n=8)	1.0 events Interval 1.0 to 2.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Diagnostic test (n=2)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Seen any doctor (n=14)	2.0 events Interval 1.0 to 4.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Received any therapy (n=7)	2.0 events Interval 1.0 to 3.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Treated in emergency room (n=2)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Outpatient surgery (n=3)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Hospitalization (n=2)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Diagnostic test (n=4)	1.0 events Interval 1.0 to 2.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: Seen any doctor (n=4)	1.0 events Interval 1.0 to 2.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: Received any therapy (n=1)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: Outpatient surgery (n=1)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 2: Diagnostic test (n=2)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Seen any doctor (n=4)	1.0 events Interval 1.0 to 2.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Received any therapy (n=3)	1.0 events Interval 1.0 to 2.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Outpatient surgery (n=3)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Seen any doctor (n=5)	1.0 events Interval 1.0 to 13.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Received any therapy (n=3)	4.0 events Interval 3.0 to 10.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Outpatient surgery (n=1)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Hospitalization (n=1)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Diagnostic test (n=2)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 3: Seen any doctor (n=1)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 3: Diagnostic test (n=2)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D7: Seen any doctor (n=1)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D7: Outpatient surgery (n=1)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Seen any doctor (n=2)	2.5 events Interval 2.0 to 3.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Received any therapy (n=1)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Outpatient surgery (n=1)	3.0 events Interval 3.0 to 3.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 4: Seen any doctor (n=1)	2.0 events Interval 2.0 to 2.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D7: Received any therapy (n=2)	3.0 events Interval 3.0 to 3.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D30: Seen any doctor (n=1)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C4D30: Received any therapy (n=1)	6.0 events Interval 6.0 to 6.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Seen any doctor (n=10)	1.5 events Interval 1.0 to 3.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Received any therapy (n=8)	2.0 events Interval 1.0 to 45.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Treated in emergency room (n=8)	1.0 events Interval 1.0 to 2.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Outpatient surgery (n=11)	1.0 events Interval 1.0 to 3.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Hospitalization (n=4)	1.0 events Interval 1.0 to 1.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 90: Diagnostic test (n=4)	1.0 events Interval 1.0 to 4.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Seen any doctor (n=4)	1.5 events Interval 1.0 to 3.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Received any therapy (n=3)	3.0 events Interval 2.0 to 22.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Treated in emergency room (n=8)	1.0 events Interval 1.0 to 3.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Outpatient surgery (n=9)	1.0 events Interval 1.0 to 5.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Hospitalization (n=6)	1.0 events Interval 1.0 to 2.0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up Day 180: Diagnostic test (n=1)	1.0 events Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection

Population: FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of days was not analyzed for participants who responded that they did not perform the event.

Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many days since their last visit they 1) were hospitalized, 2) were in nursing home, 3) required aids/devices to assist in their daily functioning.

Outcome measures

Measure	Xiapex n=6 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up: Day 180: Hospitalization (n=6)	2.5 days Interval 1.0 to 47.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up: Day 180: Required aids/devices (n=1)	2.0 days Interval 2.0 to 2.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 1: Required aids/devices (n=1)	8.0 days Interval 8.0 to 8.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Hospitalization (n=1)	2.0 days Interval 2.0 to 2.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D7: Required aids/devices (n=1)	2.0 days Interval 2.0 to 2.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Hospitalization (n=2)	8.5 days Interval 7.0 to 10.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C1D30: Required aids/devices (n=1)	20.0 days Interval 20.0 to 20.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D7: Required aids/devices (n=1)	8.0 days Interval 8.0 to 8.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Hospitalization (n=1)	3.0 days Interval 3.0 to 3.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C2D30: Required aids/devices(n=1)	6.0 days Interval 6.0 to 6.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire C3D30: Required aids/devices (n=1)	5.0 days Interval 5.0 to 5.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Baseline cycle 4: Required aids/devices (n=1)	5.0 days Interval 5.0 to 5.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up: Day 90: Hospitalization (n=4)	9.5 days Interval 2.0 to 21.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up: Day 90: In nursing home (n=1)	21.0 days Interval 21.0 to 21.0
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire Follow-up: Day 90: Required aids/devices(n=1)	16.0 days Interval 16.0 to 16.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening up to Day 180 after last injection

Population: Safety set included all participants who received at least 1 injection of Xiapex.

Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate, radial pulse and body temperature.

Outcome measures

Measure

Xiapex n=254 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening up to Day 180 after last injection

Population: Safety set included all participants who received at least 1 injection of Xiapex.

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, microscopy[if urine tested positive for blood or protein]).

Outcome measures

Measure

Xiapex n=254 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Number of Participants With Laboratory Abnormalities

48 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, Follow-up Day 180 after last injection

Population: Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.

Human serum ADA samples were analyzed for the presence or absence of anti-clostridial type I collagenase (AUX-I) and anti-clostridial type II collagenase (AUX-II) antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	Xiapex n=248 Participants A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Number of Participants With Anti-Drug Antibody (ADA) Screening: AUX-I Antibodies (n=248)	6 participants
Number of Participants With Anti-Drug Antibody (ADA) Screening: AUX-II Antibodies (n=248)	3 participants
Number of Participants With Anti-Drug Antibody (ADA) Follow-up Day 180: AUX-I Antibodies (n=239)	220 participants
Number of Participants With Anti-Drug Antibody (ADA) Follow-up Day 180: AUX-II Antibodies (n=239)	215 participants

Adverse Events

Xiapex

Serious events: 12 serious events

Other events: 212 other events

Deaths: 0 deaths

Serious adverse events

Measure	Xiapex n=254 participants at risk A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Musculoskeletal and connective tissue disorders Back pain	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Ileus paralytic	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal haemorrhage	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oesophageal stenosis	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oesophageal ulcer	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Groin abscess	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Groin infection	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Postoperative wound infection	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Femoral neck fracture	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Road traffic accident	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Aortic valve disease mixed	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Transaminases increased	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Dupuytren's contracture operation	0.39% 1/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Xiapex n=254 participants at risk A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
Blood and lymphatic system disorders Lymphadenopathy	6.7% 17/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymph Node Pain	2.4% 6/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema Peripheral	43.7% 111/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Injection Site Pain	20.9% 53/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Injection Site Haematoma	15.4% 39/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Injection Site Swelling	9.1% 23/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Injection Site Oedema	7.9% 20/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Tenderness	5.9% 15/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Axillary Pain	3.9% 10/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Injection Site Vesicles	3.9% 10/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Injection Site Haemorrhage	3.5% 9/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Injection Site Erythema	3.1% 8/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Malaise	2.4% 6/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	2.8% 7/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Skin Laceration	14.6% 37/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	13.4% 34/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Procedural Pain	12.2% 31/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Surgical Skin Tear	7.1% 18/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Post Procedural Swelling	3.5% 9/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Post Procedural Complication	3.1% 8/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood Glucose Increased	2.4% 6/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain In Extremity	25.6% 65/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	6.3% 16/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint Swelling	4.3% 11/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	2.4% 6/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	3.1% 8/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	2.8% 7/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Ecchymosis	6.7% 17/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	5.1% 13/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Blood Blister	4.7% 12/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Haematoma	19.3% 49/254 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER