Trial Outcomes & Findings for Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia (NCT NCT00564681)
NCT ID: NCT00564681
Last Updated: 2016-01-05
Results Overview
Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline represents improvement and a positive change from baseline indicates worsening.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
242 participants
Primary outcome timeframe
Baseline, Week 4
Results posted on
2016-01-05
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Botulinum Toxin Type A Formulation 2
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Placebo (Normal Saline) / Botulinum Toxin Type A
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
117
|
61
|
43
|
21
|
|
Overall Study
COMPLETED
|
106
|
58
|
40
|
19
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A
n=117 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Botulinum Toxin Type A Formulation 2
n=61 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Placebo (Normal Saline) / Botulinum Toxin Type A
n=43 Participants
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2
n=21 Participants
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<45 years
|
38 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Age, Customized
Between 45 and 65 years
|
71 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
|
Age, Customized
>65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
169 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Intent-To-Treat: All enrolled patients
Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline represents improvement and a positive change from baseline indicates worsening.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=117 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units.
|
Botulinum Toxin Type A Formulation 2
n=61 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units.
|
Placebo (Normal Saline)
n=64 Participants
Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
|
|---|---|---|---|
|
Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1
Baseline
|
40.4 Scores on a Scale
Standard Deviation 9.14
|
41.5 Scores on a Scale
Standard Deviation 9.40
|
39.6 Scores on a Scale
Standard Deviation 9.52
|
|
Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1
Change from Baseline at Week 4
|
-10.3 Scores on a Scale
Standard Deviation 9.77
|
-13.6 Scores on a Scale
Standard Deviation 10.20
|
-5.6 Scores on a Scale
Standard Deviation 8.58
|
SECONDARY outcome
Timeframe: Week 4Population: Intent-to-Treat: All enrolled patients
Physician's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=117 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units.
|
Botulinum Toxin Type A Formulation 2
n=61 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units.
|
Placebo (Normal Saline)
n=64 Participants
Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
|
|---|---|---|---|
|
Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1
|
1.3 Scores on a Scale
Standard Deviation 1.13
|
1.6 Scores on a Scale
Standard Deviation 1.04
|
0.8 Scores on a Scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Week 4Population: Intent-to-Treat: All enrolled patients
Patient's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=117 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units.
|
Botulinum Toxin Type A Formulation 2
n=61 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units.
|
Placebo (Normal Saline)
n=64 Participants
Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
|
|---|---|---|---|
|
Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1
|
1.3 Scores on a Scale
Standard Deviation 1.31
|
1.5 Scores on a Scale
Standard Deviation 1.07
|
0.6 Scores on a Scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Intent-to-Treat: All enrolled patients
Change from baseline in pain as evaluated with the TWSTRS pain subscale at Week 4 of Treatment Cycle 1. The TWSTRS pain subscale scores range from 0 to 20 (0=no pain and 20=worst pain), based on severity of neck pain (0=no pain and 10=worst pain), the duration of pain (0=none and 5=most), and the degree of disability (0=none and 5=most). A negative number change from Baseline represents a decrease in pain (improvement).
Outcome measures
| Measure |
Botulinum Toxin Type A
n=117 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units.
|
Botulinum Toxin Type A Formulation 2
n=61 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units.
|
Placebo (Normal Saline)
n=64 Participants
Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
|
|---|---|---|---|
|
Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1
Baseline
|
9.7 Scores on a Scale
Standard Deviation 4.04
|
10.0 Scores on a Scale
Standard Deviation 3.41
|
9.7 Scores on a Scale
Standard Deviation 4.13
|
|
Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1
Change from Baseline at Week 4
|
-2.8 Scores on a Scale
Standard Deviation 3.72
|
-4.1 Scores on a Scale
Standard Deviation 4.15
|
-1.3 Scores on a Scale
Standard Deviation 3.59
|
SECONDARY outcome
Timeframe: Up to 6 MonthsPopulation: Intent-to-Treat: All enrolled patients
Duration of Treatment Effect for Treatment Responders is defined as the number of days from the date of first treatment to the first visit after Week 4 of Treatment Cycle 1, at which the Total TWSTRS score reaches at least 90% of the baseline score. A treatment responder is defined as a patient who has at least a 30% reduction in Total TWSTRS score at Week 4 after the first treatment. The TWSTRS score measures the impact of cervical dystonia on patients (0=least symptoms and 85= worst symptoms).
Outcome measures
| Measure |
Botulinum Toxin Type A
n=117 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units.
|
Botulinum Toxin Type A Formulation 2
n=61 Participants
Intramuscular injections into the affected muscles. Maximum dose of 360 units.
|
Placebo (Normal Saline)
n=64 Participants
Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
|
|---|---|---|---|
|
Duration of Treatment Effect for Treatment Responders
|
111.0 Days
Interval 97.0 to 119.0
|
99.0 Days
Interval 96.0 to 113.0
|
99.0 Days
Interval 92.0 to 109.0
|
Adverse Events
Botulinum Toxin Type A
Serious events: 9 serious events
Other events: 83 other events
Deaths: 0 deaths
Botulinum Toxin Type A Formulation 2
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo (Normal Saline) / Botulinum Toxin Type A
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin Type A
n=117 participants at risk
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Botulinum Toxin Type A Formulation 2
n=61 participants at risk
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Placebo (Normal Saline) / Botulinum Toxin Type A
n=42 participants at risk
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2
n=21 participants at risk
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
2.4%
1/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
2.4%
1/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
2.4%
1/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Surgical and medical procedures
Abortion induced
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Cardiac disorders
Myocardial infarction
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
2.4%
1/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
2.4%
1/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Infections and infestations
Appendicitis
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Nervous system disorders
Sciatica
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
1.6%
1/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.8%
1/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
Other adverse events
| Measure |
Botulinum Toxin Type A
n=117 participants at risk
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Botulinum Toxin Type A Formulation 2
n=61 participants at risk
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Placebo (Normal Saline) / Botulinum Toxin Type A
n=42 participants at risk
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
|
Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2
n=21 participants at risk
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
17.1%
20/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
16.4%
10/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
11.9%
5/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.8%
1/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.2%
19/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
3.3%
2/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.5%
4/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
23.8%
5/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
8.5%
10/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
11.5%
7/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.5%
4/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.5%
2/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
General disorders
Injection site pain
|
7.7%
9/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
8.2%
5/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
7.1%
3/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
19.0%
4/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Vascular disorders
Hypertension
|
6.8%
8/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.9%
3/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
2.4%
1/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Nervous system disorders
Headache
|
6.0%
7/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.8%
6/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.5%
4/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.5%
2/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
6.0%
7/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
6.6%
4/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.8%
2/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.8%
1/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.1%
6/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.9%
3/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.8%
2/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
14.3%
3/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
6/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
3.3%
2/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
2.4%
1/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.5%
2/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
6/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
1.6%
1/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
11.9%
5/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.8%
1/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.4%
4/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
6.6%
4/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
General disorders
Fatigue
|
3.4%
4/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
7.1%
3/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Psychiatric disorders
Anxiety
|
1.7%
2/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.9%
3/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
2.4%
1/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
14.3%
3/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
2/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.9%
3/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
2.4%
1/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
14.3%
3/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
General disorders
Influenza-like illness
|
1.7%
2/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
3.3%
2/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
7.1%
3/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.7%
2/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.5%
2/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
6.6%
4/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.8%
2/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Infections and infestations
Influenza
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
3.3%
2/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.5%
2/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
General disorders
Pyrexia
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
1.6%
1/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
7.1%
3/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
4.8%
1/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Nervous system disorders
Dizziness
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
1.6%
1/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
2.4%
1/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.5%
2/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
1.6%
1/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
9.5%
2/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.85%
1/117
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/61
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
0.00%
0/42
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
14.3%
3/21
The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
- Publication restrictions are in place
Restriction type: OTHER