Trial Outcomes & Findings for Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan (NCT NCT00356603)
NCT ID: NCT00356603
Last Updated: 2018-09-04
Results Overview
Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
30 minutes or 60 Minutes after each administration
Results posted on
2018-09-04
Participant Flow
This study was conducted from 20 June 2006 to 07 August 2006 across four centers in Japan.
A total of 75 participants with history of migraine or cluster headache persisting for at least 6 months had entered into the study.
Participant milestones
| Measure |
Migraine
Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 milligrams (mg) kit product (0.5 milliliter \[mL\] containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Cluster Headache
Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
36
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Migraine
Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 milligrams (mg) kit product (0.5 milliliter \[mL\] containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Cluster Headache
Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
|---|---|---|
|
Overall Study
Other
|
6
|
3
|
Baseline Characteristics
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
Baseline characteristics by cohort
| Measure |
Migraine
n=33 Participants
Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Cluster Headache
n=33 Participants
Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.2 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
37.4 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
39.3 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes or 60 Minutes after each administrationPopulation: Full Analysis Set (FAS) Population included patients who self-administered the study product and have at least one efficacy data.
Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.
Outcome measures
| Measure |
Migraine
n=33 Participants
Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Cluster Headache
n=33 Participants
Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Migraine + Cluster Headache
n=66 Participants
Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
|---|---|---|---|
|
Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)
|
93.9 Percentage of participants
Interval 79.8 to 99.3
|
93.9 Percentage of participants
Interval 79.8 to 99.3
|
93.9 Percentage of participants
Interval 85.2 to 98.3
|
SECONDARY outcome
Timeframe: Up to 2 monthsPopulation: FAS Population.
The subject-rated acceptability of sumatriptan succinate injection 3 mg kit product had three questions, question 1 was "Was the kit product easy to use?", question 2 was "Do you want to use the kit product in the future?" and question 3 was "Do you consider that the kit product is necessary for the treatment of your illness?". The responses were given as yes or no. Data for number of participants who responded to the three questions as yes or no has been presented.
Outcome measures
| Measure |
Migraine
n=33 Participants
Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Cluster Headache
n=33 Participants
Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Migraine + Cluster Headache
n=66 Participants
Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
|---|---|---|---|
|
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
Question 1: Yes
|
32 Participants
|
33 Participants
|
65 Participants
|
|
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
Question 1: No
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
Question 2: Yes
|
31 Participants
|
31 Participants
|
62 Participants
|
|
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
Question 2: No
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
Question 3: Yes
|
31 Participants
|
29 Participants
|
60 Participants
|
|
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
Question 3: No
|
2 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 2 monthsPopulation: FAS Population.
The investigator/sub investigator-rated successful self-injection rate was the percentage of participants who were able to use the kit as directed by the investigator/ sub investigator. The response was given as yes or no. Data for percentage of participants who were actually able to use the kit as directed has been presented.
Outcome measures
| Measure |
Migraine
n=33 Participants
Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Cluster Headache
n=33 Participants
Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Migraine + Cluster Headache
n=66 Participants
Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
|---|---|---|---|
|
Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
Adverse Events
Migraine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cluster Headache
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Migraine + Cluster Headache
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Migraine
n=33 participants at risk
Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Cluster Headache
n=33 participants at risk
Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
Migraine + Cluster Headache
n=66 participants at risk
Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
|
|---|---|---|---|
|
General disorders
Malaise
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
6.1%
2/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
4.5%
3/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
6.1%
2/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
4.5%
3/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
9.1%
3/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
4.5%
3/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
General disorders
Asthenia
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
2/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
2/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
2/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
General disorders
Chest discomfort
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
6.1%
2/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
2/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
General disorders
Feeling abnormal
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
1.5%
1/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
1.5%
1/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
1.5%
1/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Investigations
White blood cell count increased
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
1.5%
1/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Investigations
Protein urine present
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
1.5%
1/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
1.5%
1/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
1.5%
1/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal discomfort
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
1.5%
1/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
1.5%
1/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
|
Cardiac disorders
Palpitations
|
3.0%
1/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
0.00%
0/33 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
1.5%
1/66 • All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER