Trial Outcomes & Findings for A Research Trial of Aralast in New Onset Diabetes (RETAIN) (NCT NCT01183468)
NCT ID: NCT01183468
Last Updated: 2018-06-13
Results Overview
No results for the primary outcome measure are available since the study was terminated prior to reaching the outcome measure time frame of 52 weeks.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Week 52
Results posted on
2018-06-13
Participant Flow
Twelve of the fifteen centers enrolled a total of 17 newly diagnosed (within 100 days of Visit 0 first low dose infusion) Type 1 Diabetes Mellitus participants.
Participant milestones
| Measure |
Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs
Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
|
Part 1a (Aralast NP)-Subjects 8-15 Yrs
Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
|
Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs
Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week
|
Part 1b (Aralast NP)-Subjects 8-17 Yrs
Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
7
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs
Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
|
Part 1a (Aralast NP)-Subjects 8-15 Yrs
Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
|
Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs
Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week
|
Part 1b (Aralast NP)-Subjects 8-17 Yrs
Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Research Trial of Aralast in New Onset Diabetes (RETAIN)
Baseline characteristics by cohort
| Measure |
Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs
n=8 Participants
Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
|
Part 1a (Aralast NP)-Subjects 8-15 Yrs
n=9 Participants
Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
|
Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs
Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week
|
Part 1b (Aralast NP)-Subjects 8-17 Yrs
Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
—
|
—
|
13 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
4 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
20.6 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
10.7 years
STANDARD_DEVIATION 2.2 • n=107 Participants
|
—
|
—
|
15.4 years
STANDARD_DEVIATION 6.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
—
|
—
|
6 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
—
|
—
|
11 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
—
|
—
|
17 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: Enrolled Sample
No results for the primary outcome measure are available since the study was terminated prior to reaching the outcome measure time frame of 52 weeks.
Outcome measures
Outcome data not reported
Adverse Events
Subjects Aged 16 - 35 Years
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Subjects Aged 8 - 15 Years
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects Aged 16 - 35 Years
n=8 participants at risk
Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
|
Subjects Aged 8 - 15 Years
n=9 participants at risk
Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
Other adverse events
| Measure |
Subjects Aged 16 - 35 Years
n=8 participants at risk
Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
|
Subjects Aged 8 - 15 Years
n=9 participants at risk
Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
|
|---|---|---|
|
Endocrine disorders
Goitre
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Eye disorders
Blepharitis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 4 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 12 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
44.4%
4/9 • Number of events 7 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
44.4%
4/9 • Number of events 5 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
General disorders
Chest pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
General disorders
Infusion site haematoma
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 4 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
General disorders
Infusion site pain
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
General disorders
Injection site haematoma
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Ear infection
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Fungal infection
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Influenza
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
2/8 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Pharyngitis streptococcal
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Tooth infection
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
44.4%
4/9 • Number of events 10 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
2/8 • Number of events 9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.5%
1/8 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Investigations
Lymphocyte count increased
|
12.5%
1/8 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 4 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
87.5%
7/8 • Number of events 69 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
88.9%
8/9 • Number of events 104 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
3/8 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 4 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
44.4%
4/9 • Number of events 77 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Nervous system disorders
Sinus headache
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Psychiatric disorders
Panic attack
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Renal and urinary disorders
Hypercalciuria
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 4 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Renal and urinary disorders
Nephrolithiasis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
3/8 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 4 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
37.5%
3/8 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
22.2%
2/9 • Number of events 9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 3 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
33.3%
3/9 • Number of events 4 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 2 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/8 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
0.00%
0/9 • Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013.
Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first.
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place