Trial Outcomes & Findings for A Multi-Center Study Of CD07743 for the Improvement of Lateral Canthal Lines (CROW'S FEET) (NCT NCT01308060)
NCT ID: NCT01308060
Last Updated: 2020-05-01
Results Overview
A positive response (responder) is defined as a grade of 0 or 1 (none or mild), as assessed by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
335 participants
Primary outcome timeframe
Week 4
Results posted on
2020-05-01
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
Part B was open-label, active treatment to all participants up to 1 year. (Therefore, "reason withdrawn" cannot be specified per group.)
|
Placebo
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
Part B was open-label, active treatment to all participants up to 1 year. (Therefore, "reason withdrawn" cannot be specified per group.)
|
|---|---|---|
|
Part A
STARTED
|
252
|
83
|
|
Part A
COMPLETED
|
238
|
77
|
|
Part A
NOT COMPLETED
|
14
|
6
|
|
Part B
STARTED
|
238
|
77
|
|
Part B
COMPLETED
|
219
|
69
|
|
Part B
NOT COMPLETED
|
19
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi-Center Study Of CD07743 for the Improvement of Lateral Canthal Lines (CROW'S FEET)
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A
n=252 Participants
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
|
Placebo
n=83 Participants
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
|
Total
n=335 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
234 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
249 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
121 participants
n=5 Participants
|
39 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Region of Enrollment
France
|
92 participants
n=5 Participants
|
31 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
39 participants
n=5 Participants
|
13 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4A positive response (responder) is defined as a grade of 0 or 1 (none or mild), as assessed by the investigator.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=252 Participants
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
|
Placebo
n=83 Participants
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
|
|---|---|---|
|
Number of Responders on the Severity of Lateral Canthal Lines "at Maximum Smile".
|
119 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 4Participants were asked to assess their degree of satisfaction with the appearance of their lateral canthal lines using a 4-point scale with the grades Very satisfied, Satisfied, Dissatisfied, and Very dissatisfied. A participant is considered satisfied if he/she answers Very satisfied or Satisfied.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=252 Participants
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
|
Placebo
n=83 Participants
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
|
|---|---|---|
|
Number of Participants Satisfied With the Appearance of Their Lateral Canthal Lines
|
165 Participants
|
14 Participants
|
Adverse Events
Botulinum Toxin Type A - Part A
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo - Part A
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Botulinum Toxin Type A - Part B
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin Type A - Part A
n=252 participants at risk
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo.
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
|
Placebo - Part A
n=83 participants at risk
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo.
|
Botulinum Toxin Type A - Part B
n=326 participants at risk
Part B was open-label, active treatment to all participants up to 1 year. The retreatment, or first treatment if randomized to placebo, injection defines for each subject the start of Part B.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.40%
1/252 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/326
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.40%
1/252 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/326
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.40%
1/252 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/326
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.40%
1/252 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/326
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.40%
1/252 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/326
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.40%
1/252 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/326
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.40%
1/252 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/326
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
1.2%
1/83 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/326
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign uterine neoplasm
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Ear and labyrinth disorders
Deafness transitory
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Psychiatric disorders
Depression
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/252
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.00%
0/83
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
0.31%
1/326 • Number of events 1
Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject). AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place