Trial Outcomes & Findings for Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization (NCT NCT05118204)
NCT ID: NCT05118204
Last Updated: 2025-10-31
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
2025-10-31
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=5 Participants
|
49.4 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Opioid Use Disorder status
Opioid use disorder moderate or severe
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Opioid Use Disorder status
Opioid use disorder mild or Opioid misuse
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 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 monthsThe 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
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 3, and 6 monthsThe 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
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsMean pain intensity score, measured using the Brief Pain Inventory (BPI), will be reported for each study arm.
Outcome measures
Outcome data not reported
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.
Outcome measures
Outcome data not reported
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.
|
|
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.
|
|
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.
|
|
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