Trial Outcomes & Findings for A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches (NCT NCT00156910)
NCT ID: NCT00156910
Last Updated: 2013-11-18
Results Overview
Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted \>= 4 continuous hours.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
679 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2013-11-18
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
|
Placebo (Saline)
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
|
|---|---|---|
|
Double-Blind Phase (DB)
STARTED
|
341
|
338
|
|
Double-Blind Phase (DB)
COMPLETED
|
296
|
295
|
|
Double-Blind Phase (DB)
NOT COMPLETED
|
45
|
43
|
|
Open-Label Phase (OL)
STARTED
|
285
|
286
|
|
Open-Label Phase (OL)
COMPLETED
|
252
|
231
|
|
Open-Label Phase (OL)
NOT COMPLETED
|
33
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A
n=341 Participants
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
|
Placebo (Saline)
n=338 Participants
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
|
Total
n=679 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 40years
|
144 participants
n=5 Participants
|
128 participants
n=7 Participants
|
272 participants
n=5 Participants
|
|
Age, Customized
>= 40 years
|
197 participants
n=5 Participants
|
210 participants
n=7 Participants
|
407 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
304 Participants
n=5 Participants
|
290 Participants
n=7 Participants
|
594 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Intent to Treat
Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted \>= 4 continuous hours.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=341 Participants
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
|
Placebo (Saline)
n=338 Participants
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
|
|---|---|---|
|
Change in Frequency of Headache Episodes
Baseline
|
12.3 Headache Episodes
Standard Deviation 5.23
|
13.4 Headache Episodes
Standard Deviation 5.71
|
|
Change in Frequency of Headache Episodes
Change from Baseline at Week 24
|
-5.2 Headache Episodes
Standard Deviation 5.27
|
-5.3 Headache Episodes
Standard Deviation 5.85
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Intent to Treat
Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day \[00:00 to 23:59\] for which the patient reported \>= 4 continuous hours of headache
Outcome measures
| Measure |
Botulinum Toxin Type A
n=341 Participants
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
|
Placebo (Saline)
n=338 Participants
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
|
|---|---|---|
|
Change in Frequency of Headache Days
Change from Baseline at Week 24
|
-7.8 Headache Days
Standard Deviation 6.57
|
-6.4 Headache Days
Standard Deviation 6.69
|
|
Change in Frequency of Headache Days
Baseline
|
20.0 Headache Days
Standard Deviation 3.73
|
19.8 Headache Days
Standard Deviation 3.71
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Intent to Treat
Mean change from baseline in frequency (number) of acute headache pain medication intakes during the 28 day period ending with Week 24. Medication intakes defined as the number of times a patient took acute headache pain medication regardless of dose or type/number of medications taken at the same time.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=341 Participants
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
|
Placebo (Saline)
n=338 Participants
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
|
|---|---|---|
|
Change in Frequency of Acute Headache Pain Medication Intakes
Baseline
|
29.1 Medication Intakes
Standard Deviation 19.27
|
30.4 Medication Intakes
Standard Deviation 22.29
|
|
Change in Frequency of Acute Headache Pain Medication Intakes
Change from Baseline at Week 24
|
-10.3 Medication Intakes
Standard Deviation 18.67
|
-10.4 Medication Intakes
Standard Deviation 18.54
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Intent to Treat
Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with \>= 4 continuous hours of headache meeting ICHD-II criteria for migraine or probable migraine.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=341 Participants
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
|
Placebo (Saline)
n=338 Participants
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
|
|---|---|---|
|
Change in Frequency of Migraine/Probable Migraine Headache Days
Baseline
|
19.1 Migraine/Probable Migraine Headache Days
Standard Deviation 4.04
|
19.1 Migraine/Probable Migraine Headache Days
Standard Deviation 4.05
|
|
Change in Frequency of Migraine/Probable Migraine Headache Days
Change from Baseline at Week 24
|
-7.6 Migraine/Probable Migraine Headache Days
Standard Deviation 6.51
|
-6.1 Migraine/Probable Migraine Headache Days
Standard Deviation 6.78
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Intent to Treat
Mean change from baseline in frequency (number) of migraine/probable migraine headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted \>= 4 continuous hours and met ICHD-II criteria for migraine or probable migraine.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=341 Participants
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
|
Placebo (Saline)
n=338 Participants
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
|
|---|---|---|
|
Change in Frequency of Migraine/Probable Migraine Headache Episodes
Baseline
|
11.5 Migraine/Prob Migraine Headache Episodes
Standard Deviation 5.06
|
12.7 Migraine/Prob Migraine Headache Episodes
Standard Deviation 5.72
|
|
Change in Frequency of Migraine/Probable Migraine Headache Episodes
Change from Baseline at Week 24
|
-4.8 Migraine/Prob Migraine Headache Episodes
Standard Deviation 5.06
|
-4.9 Migraine/Prob Migraine Headache Episodes
Standard Deviation 5.74
|
Adverse Events
Botulinum Toxin Type A
Serious events: 42 serious events
Other events: 215 other events
Deaths: 0 deaths
Placebo (Saline)
Serious events: 8 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin Type A
n=624 participants at risk
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
|
Placebo (Saline)
n=334 participants at risk
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
|
|---|---|---|
|
Nervous system disorders
Migraine
|
0.64%
4/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
General disorders
Non-cardiac chest pain
|
0.48%
3/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.48%
3/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.32%
2/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Musculoskeletal and connective tissue disorders
Invertebral disc protrusion
|
0.32%
2/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.32%
2/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Vomiting
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Cardiac disorders
Atrial fibrillation
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Cardiac disorders
Cardiac arrest
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Cellulitis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Nervous system disorders
Cerebral infarction
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Nervous system disorders
Cervical cord compression
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
General disorders
Chest pain
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Diverticulitis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Nervous system disorders
Headache
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Psychiatric disorders
Major depression
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Nervous system disorders
Migraine without aura
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Investigations
Parvovirus B19 serology positive
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Pneumonia
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Proctitis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Pyelonephritis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Rocky mountain spotted fever
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Nervous system disorders
Status migrainosus
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Nervous system disorders
Syncope
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Cardiac disorders
Angina pectoris
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Catheter site infection
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complications
|
0.00%
0/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Peridiverticular abscess
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Psychiatric disorders
Substance abuse
|
0.16%
1/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.30%
1/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
Other adverse events
| Measure |
Botulinum Toxin Type A
n=624 participants at risk
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
|
Placebo (Saline)
n=334 participants at risk
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.1%
63/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
3.3%
11/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Sinusitis
|
7.4%
46/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
5.1%
17/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
37/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
6.0%
20/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.6%
35/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
0.00%
0/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
34/624
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
4.8%
16/334
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
|
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