Trial Outcomes & Findings for Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization (NCT NCT05118204)
NCT ID: NCT05118204
Last Updated: 2026-05-08
Results Overview
The percentage of participants who start BUP treatment, defined as receiving BUP 7 days after the baseline visit, will be reported for each arm.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
7 days
Results posted on
2026-05-08
Participant Flow
Participant milestones
| Measure |
BUP Microdose Induction
Participants in this arm will receive a novel Buprenorphine (BUP) microdose induction protocol.
BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists).
Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Treatment As Usual (TAU)
Participants in this arm will receive standard BUP induction protocol.
Treatment As Usual (TAU): 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
BUP Microdose Induction
Participants in this arm will receive a novel Buprenorphine (BUP) microdose induction protocol.
BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists).
Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Treatment As Usual (TAU)
Participants in this arm will receive standard BUP induction protocol.
Treatment As Usual (TAU): 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
Baseline characteristics by cohort
| Measure |
BUP Microdose Induction
n=12 Participants
Participants in this arm will receive a novel BUP microdose induction protocol.
BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists).
Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Treatment As Usual (TAU)
n=11 Participants
Participants in this arm will receive standard BUP induction protocol.
TAU: 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 16.6 • n=41 Participants
|
49.4 years
STANDARD_DEVIATION 15.4 • n=40 Participants
|
47.3 years
STANDARD_DEVIATION 15.8 • n=81 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=41 Participants
|
3 Participants
n=40 Participants
|
9 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=41 Participants
|
8 Participants
n=40 Participants
|
14 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=41 Participants
|
5 Participants
n=40 Participants
|
13 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=41 Participants
|
6 Participants
n=40 Participants
|
10 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=41 Participants
|
6 Participants
n=40 Participants
|
11 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=41 Participants
|
4 Participants
n=40 Participants
|
8 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
|
Opioid Use Disorder status
Opioid use disorder moderate or severe
|
5 Participants
n=41 Participants
|
4 Participants
n=40 Participants
|
9 Participants
n=81 Participants
|
|
Opioid Use Disorder status
Opioid use disorder mild or Opioid misuse
|
7 Participants
n=41 Participants
|
7 Participants
n=40 Participants
|
14 Participants
n=81 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe percentage of participants who start BUP treatment, defined as receiving BUP 7 days after the baseline visit, will be reported for each arm.
Outcome measures
| Measure |
BUP Microdose Induction
n=12 Participants
Participants in this arm will receive a novel BUP microdose induction protocol.
BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists).
Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Treatment As Usual (TAU)
n=11 Participants
Participants in this arm will receive standard BUP induction protocol.
TAU: 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
|---|---|---|
|
BUP Treatment Uptake
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 1, 3, and 6 monthsPopulation: Illicit opioid use is self-reported; therefore, the outcome is only reported for participants with follow-up study visits.
The mean number of days of illicit opioid use, defined as self-reported use of heroin, fentanyl, or non-prescribed opioid analgesics in the prior 30 days based on the Addiction Severity Index, will be reported for each arm.
Outcome measures
| Measure |
BUP Microdose Induction
n=12 Participants
Participants in this arm will receive a novel BUP microdose induction protocol.
BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists).
Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Treatment As Usual (TAU)
n=11 Participants
Participants in this arm will receive standard BUP induction protocol.
TAU: 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
|---|---|---|
|
Illicit Opioid Use
Illicit opioid use at 1 month
|
0.2 days
Standard Deviation 0.6
|
3.8 days
Standard Deviation 10.6
|
|
Illicit Opioid Use
Illicit opioid use at 3 months
|
0.7 days
Standard Deviation 1.4
|
0.1 days
Standard Deviation 0.3
|
|
Illicit Opioid Use
Illicit opioid use at 6 months
|
2.3 days
Standard Deviation 7.0
|
2.9 days
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 1, 3, and 6 monthsPopulation: Data was available for all participants at each time point as review was based on medical records.
The number/percentage of participants who are retained in BUP treatment, defined as having a BUP prescription written 180-210 days (6-month retention) after enrollment, will be reported for each arm.
Outcome measures
| Measure |
BUP Microdose Induction
n=12 Participants
Participants in this arm will receive a novel BUP microdose induction protocol.
BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists).
Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Treatment As Usual (TAU)
n=11 Participants
Participants in this arm will receive standard BUP induction protocol.
TAU: 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
|---|---|---|
|
BUP Retention in Care
3 Month
|
6 Participants
|
5 Participants
|
|
BUP Retention in Care
6 Month
|
5 Participants
|
3 Participants
|
|
BUP Retention in Care
1 Month
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 monthsMean pain intensity score, measured using the Brief Pain Inventory (BPI), will be reported for each study arm. The pain intensity score has 4 items that are each rated on a scale from 0 (low intensity) to 10 (high intensity). The score reported is the average score from the 4-items also reported on a scale of 0-10.
Outcome measures
| Measure |
BUP Microdose Induction
n=9 Participants
Participants in this arm will receive a novel BUP microdose induction protocol.
BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists).
Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Treatment As Usual (TAU)
n=9 Participants
Participants in this arm will receive standard BUP induction protocol.
TAU: 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
|---|---|---|
|
Pain Intensity
|
4.7 score on a scale
Standard Deviation 2.9
|
6.8 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 3 monthsMean pain interference score, measured using the pain interference scale from the BPI, which is a 7-item instrument measuring the impact of pain on daily activities and physical functioning, will be reported for each study arm. Each item is rated on a scale from 0 (low interference) to 10 (high interference). The score reported is the average score from the 7-items also reported on a scale of 0-10.
Outcome measures
| Measure |
BUP Microdose Induction
n=9 Participants
Participants in this arm will receive a novel BUP microdose induction protocol.
BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists).
Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Treatment As Usual (TAU)
n=9 Participants
Participants in this arm will receive standard BUP induction protocol.
TAU: 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
|---|---|---|
|
Pain Interference
|
3.7 score on a scale
Standard Deviation 3.9
|
5.3 score on a scale
Standard Deviation 2.9
|
Adverse Events
BUP Microdose Induction
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Treatment As Usual (TAU)
Serious events: 6 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BUP Microdose Induction
n=12 participants at risk
Participants in this arm will receive a novel BUP microdose induction protocol.
BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists).
Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Treatment As Usual (TAU)
n=11 participants at risk
Participants in this arm will receive standard BUP induction protocol.
TAU: 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization
|
41.7%
5/12 • Number of events 13 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
54.5%
6/11 • Number of events 20 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Injury, poisoning and procedural complications
Overdose
|
8.3%
1/12 • Number of events 2 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Psychiatric disorders
Suicidal ideation
|
16.7%
2/12 • Number of events 2 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
0.00%
0/11 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
Other adverse events
| Measure |
BUP Microdose Induction
n=12 participants at risk
Participants in this arm will receive a novel BUP microdose induction protocol.
BUP microdose induction: Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists).
Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
Treatment As Usual (TAU)
n=11 participants at risk
Participants in this arm will receive standard BUP induction protocol.
TAU: 2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
Linkage to outpatient BUP treatment: Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
|
|---|---|---|
|
Infections and infestations
Abscess
|
16.7%
2/12 • Number of events 2 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
0.00%
0/11 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Nervous system disorders
Asthenia
|
25.0%
3/12 • Number of events 3 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
36.4%
4/11 • Number of events 7 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
General disorders
Chills
|
33.3%
4/12 • Number of events 8 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
36.4%
4/11 • Number of events 8 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 2 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
0.00%
0/11 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Infections and infestations
Flu Syndrome
|
33.3%
4/12 • Number of events 6 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
0.00%
0/11 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Nervous system disorders
Headache
|
75.0%
9/12 • Number of events 18 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
27.3%
3/11 • Number of events 4 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Infections and infestations
Infection
|
16.7%
2/12 • Number of events 2 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
27.3%
3/11 • Number of events 3 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
25.0%
3/12 • Number of events 5 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
General disorders
Pain - general
|
91.7%
11/12 • Number of events 26 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
100.0%
11/11 • Number of events 27 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Gastrointestinal disorders
Pain - abdominal
|
41.7%
5/12 • Number of events 9 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
27.3%
3/11 • Number of events 4 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
58.3%
7/12 • Number of events 19 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
90.9%
10/11 • Number of events 26 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
General disorders
Withdrawal syndrome
|
16.7%
2/12 • Number of events 2 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
27.3%
3/11 • Number of events 8 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Gastrointestinal disorders
Constipation
|
58.3%
7/12 • Number of events 9 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
63.6%
7/11 • Number of events 15 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
4/12 • Number of events 7 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
36.4%
4/11 • Number of events 5 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Gastrointestinal disorders
Acid Reflux
|
8.3%
1/12 • Number of events 2 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
9/12 • Number of events 19 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
63.6%
7/11 • Number of events 12 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
5/12 • Number of events 7 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
54.5%
6/11 • Number of events 8 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Psychiatric disorders
Anxiety
|
66.7%
8/12 • Number of events 21 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
63.6%
7/11 • Number of events 16 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Psychiatric disorders
Depression
|
58.3%
7/12 • Number of events 17 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
54.5%
6/11 • Number of events 14 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
General disorders
Dizziness
|
33.3%
4/12 • Number of events 6 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
45.5%
5/11 • Number of events 6 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
General disorders
Insomnia
|
83.3%
10/12 • Number of events 24 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
54.5%
6/11 • Number of events 11 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
General disorders
Nervousness
|
50.0%
6/12 • Number of events 13 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
45.5%
5/11 • Number of events 11 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Eye disorders
Lacrimation
|
16.7%
2/12 • Number of events 3 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
18.2%
2/11 • Number of events 4 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
General disorders
Somnolence
|
25.0%
3/12 • Number of events 3 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
45.5%
5/11 • Number of events 9 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
33.3%
4/12 • Number of events 6 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
27.3%
3/11 • Number of events 4 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Infections and infestations
Pharyngitis
|
16.7%
2/12 • Number of events 3 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
27.3%
3/11 • Number of events 5 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
33.3%
4/12 • Number of events 7 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
18.2%
2/11 • Number of events 4 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
33.3%
4/12 • Number of events 6 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
45.5%
5/11 • Number of events 7 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
Vascular disorders
Vasodilation
|
16.7%
2/12 • Number of events 3 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
0.00%
0/11 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
|
General disorders
Fatigue
|
66.7%
8/12 • Number of events 16 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
54.5%
6/11 • Number of events 10 • Up to approximately 6 months (24 weeks)
A structured form was used to collect adverse event information at week 1, 4, 12, 24 study visits. A researcher asked participants whether they had experienced: abscess, asthenia, chills, fever, flu syndrome, headache, infection, injury/accident, pain, abdominal pain, back pain, withdrawal syndrome, constipation, diarrhea, dyspepsia, nausea, vomiting, anxiety, depression, dizziness, insomnia, nervousness, somnolence, cough, pharyngitis, rhinitis, sweating, lacrimation, vasodilation, fatigue.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place