Trial Outcomes & Findings for Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain (NCT NCT01451385)
NCT ID: NCT01451385
Last Updated: 2020-09-18
Results Overview
Collection of AEs began with subject's signing of the informed consent form, continued throughout the trial, and ended 7 days following the last dose of study drug, or at early termination. Treatment emergent AEs (TEAEs) are AEs that occurred after the first dose of study drug. TEAEs leading to discontinuation include 2 subjects who died (deaths not related to study drug). Clinically significant changes in values from physical exam, vital signs, clinical laboratory tests, and pulse oximetry were included as treatment emergent adverse events (TEAEs).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
376 participants
Primary outcome timeframe
5 Weeks
Results posted on
2020-09-18
Participant Flow
After a screening period of up to 14 days, enrolled participants began treatment
Participant milestones
| Measure |
All Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
Overall Study
STARTED
|
376
|
|
Overall Study
COMPLETED
|
285
|
|
Overall Study
NOT COMPLETED
|
91
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only participants with OA of the hip or knee were included in this outcome measure
Baseline characteristics by cohort
| Measure |
All Participants
n=376 Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 13.72 • n=376 Participants
|
|
Sex: Female, Male
Female
|
220 Participants
n=376 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=376 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
58 Participants
n=376 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
318 Participants
n=376 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=376 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=376 Participants
|
|
Race (NIH/OMB)
Asian
|
62 Participants
n=376 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=376 Participants
|
|
Race (NIH/OMB)
Black or African American
|
75 Participants
n=376 Participants
|
|
Race (NIH/OMB)
White
|
237 Participants
n=376 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=376 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=376 Participants
|
|
Modified Brief Pain Index - Short Form: Pain Intensity
Worst pain in last 24 hours
|
7.6 score on a scale
STANDARD_DEVIATION 1.32 • n=376 Participants
|
|
Modified Brief Pain Index - Short Form: Pain Intensity
Least pain in last 24 hours
|
5.6 score on a scale
STANDARD_DEVIATION 1.94 • n=376 Participants
|
|
Modified Brief Pain Index - Short Form: Pain Intensity
Average pain in the last 24 hours
|
6.7 score on a scale
STANDARD_DEVIATION 1.38 • n=376 Participants
|
|
Modified Brief Pain Index - Short Form: Pain Intensity
Pain right now
|
6.7 score on a scale
STANDARD_DEVIATION 1.64 • n=376 Participants
|
|
Modified Brief Pain Inventory-Short Form: Percent Pain Relief from Medication
|
13.2 percentage pain relief from medication
STANDARD_DEVIATION 21.93 • n=376 Participants
|
|
Modified Brief Pain Inventory-Short Form: Pain Interference Scores
|
5.4 score on a scale
STANDARD_DEVIATION 2.03 • n=376 Participants
|
|
Western Ontario and McMaster U. Scores for Participants With Osteoarthritis (OA) of the Hip or Knee
|
11.74 score on a scale
STANDARD_DEVIATION 2.971 • n=140 Participants • Only participants with OA of the hip or knee were included in this outcome measure
|
|
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Stiffness Score
|
4.94 score on a scale
STANDARD_DEVIATION 1.254 • n=140 Participants • Participants in the safety population with OA of the hip or knee
|
|
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Physical Function
|
38.96 score on a scale
STANDARD_DEVIATION 9.863 • n=140 Participants • Participants in the safety population with OA of the hip or knee
|
|
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Total Score
|
55.63 score on a scale
STANDARD_DEVIATION 13.251 • n=140 Participants • Participants in the safety population with OA of the hip or knee
|
|
Roland-Morris Low Back Pain and Disability Scores for Participants with Chronic Low Back Pain
|
10.9 score on a scale
STANDARD_DEVIATION 5.27 • n=235 Participants • Participants in the safety population with chronic low back pain
|
PRIMARY outcome
Timeframe: 5 WeeksPopulation: All participants = safety population
Collection of AEs began with subject's signing of the informed consent form, continued throughout the trial, and ended 7 days following the last dose of study drug, or at early termination. Treatment emergent AEs (TEAEs) are AEs that occurred after the first dose of study drug. TEAEs leading to discontinuation include 2 subjects who died (deaths not related to study drug). Clinically significant changes in values from physical exam, vital signs, clinical laboratory tests, and pulse oximetry were included as treatment emergent adverse events (TEAEs).
Outcome measures
| Measure |
All Participants
n=376 Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
Summary of Adverse Events (AEs)
Had any TEAE
|
235 Participants
|
|
Summary of Adverse Events (AEs)
Had a Serious AE
|
4 Participants
|
|
Summary of Adverse Events (AEs)
Died
|
2 Participants
|
|
Summary of Adverse Events (AEs)
Had a TEAE leading to discontinuation
|
73 Participants
|
|
Summary of Adverse Events (AEs)
Had a Severe TEAE
|
17 Participants
|
|
Summary of Adverse Events (AEs)
Had a TEAE related to study medication
|
200 Participants
|
SECONDARY outcome
Timeframe: at end of treatment (within 5 weeks)Population: All participants = safety population with a score at end of treatment (week 5)
Participants rate their pain on a score from 0=no pain to 10=pain as bad as you can imagine
Outcome measures
| Measure |
All Participants
n=359 Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
Modified Brief Pain Index - Short Form: Pain Intensity
Worst pain in the last 24 hours
|
4.0 score on a scale
Standard Deviation 2.58
|
|
Modified Brief Pain Index - Short Form: Pain Intensity
Least pain in last 24 hours
|
2.4 score on a scale
Standard Deviation 2.13
|
|
Modified Brief Pain Index - Short Form: Pain Intensity
Average pain in the last 24 hours
|
3.2 score on a scale
Standard Deviation 2.25
|
|
Modified Brief Pain Index - Short Form: Pain Intensity
Pain right now
|
2.8 score on a scale
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: at end of treatment (within 5 weeks)Population: Safety population with a score at end of treatment
Participants rate percent pain relief from medication on a scale from 0% (no relief) to 100% (complete relief)
Outcome measures
| Measure |
All Participants
n=359 Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
Modified Brief Pain Index - Short Form: Percent Pain Relief From Medication
|
67.7 percentage of relief from medication
Standard Deviation 28.47
|
SECONDARY outcome
Timeframe: at end of treatment (within 5 weeks)Population: Safety population with a score at end of treatment
Participants answer several questions about how much the pain interferes with their quality of life. The answers range from 0 = no interference to 10=completely interferes, and the average score for all the questions is recorded.
Outcome measures
| Measure |
All Participants
n=359 Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
Modified Brief Pain Inventory-Short Form: Pain Interference Scores
|
2.2 score on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: End of treatment (within 5 weeks)Population: Participants in the safety population with OA of the hip or knee and a score at end of treatment
Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC pain score ranges from 0 to 20, with higher scores representing worse pain.
Outcome measures
| Measure |
All Participants
n=134 Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Pain Score
|
6.22 score on a scale
Standard Deviation 4.016
|
SECONDARY outcome
Timeframe: End of treatment (within 5 weeks)Population: Participants in the safety population with OA of the hip or knee and a score at end of treatment
Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC stiffness score ranges from 0 to 8, with higher scores representing worse stiffness.
Outcome measures
| Measure |
All Participants
n=134 Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Stiffness Score
|
2.84 score on a scale
Standard Deviation 1.713
|
SECONDARY outcome
Timeframe: End of treatment (within 5 weeks)Population: Participants in the safety population with OA of the hip or knee and a score at end of treatment
Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC physical function score ranges from 0 to 68, with higher scores representing worse functional limitations.
Outcome measures
| Measure |
All Participants
n=134 Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Physical Function Score
|
21.30 score on a scale
Standard Deviation 13.180
|
SECONDARY outcome
Timeframe: End of treatment (within 5 weeks)Population: Participants in the safety population with OA of the hip or knee and a score at end of treatment
Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC total score ranges from 0 to 96, with higher scores representing worse pain/disability.
Outcome measures
| Measure |
All Participants
n=134 Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Total Score
|
30.35 score on a scale
Standard Deviation 18.450
|
SECONDARY outcome
Timeframe: End of treatment (within 5 weeks)Population: Participants in the safety population with chronic low back pain and a score at end of treatment
Roland-Morris Low Back Pain and Disability Scores for participants with chronic low back pain range from 0 to 24, with higher scores representing greater disability.
Outcome measures
| Measure |
All Participants
n=224 Participants
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
Roland-Morris Low Back Pain and Disability Scores for Participants With Chronic Low Back Pain
|
6.1 score on a scale
Standard Deviation 5.75
|
Adverse Events
All Participants
Serious events: 4 serious events
Other events: 235 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
All Participants
n=376 participants at risk
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
Other adverse events
| Measure |
All Participants
n=376 participants at risk
All participants receive 2 tablets of COV795 every 12 hours for up to 35 days
|
|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Palpitations
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Ear and labyrinth disorders
Ear pain
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Ear and labyrinth disorders
Tinnitus
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Ear and labyrinth disorders
Vertigo
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Eye disorders
Diplopia
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Eye disorders
Vision blurred
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.1%
4/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Colonic polyp
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Constipation
|
11.2%
42/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Dental caries
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
5/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Dry mouth
|
2.7%
10/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
6/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
23.1%
87/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
57/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
General disorders
Chest discomfort
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
General disorders
Chills
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
General disorders
Crepitations
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
General disorders
Fatigue
|
2.1%
8/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
General disorders
Feeling jittery
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
General disorders
Oedema peripheral
|
0.80%
3/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
General disorders
Pain
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
General disorders
Thirst
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Body tinea
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Bronchitis
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Cellulitis
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Gastroenteritis
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Gastroenteritis viral
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Helicobacter infection
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Influenza
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Nasopharyngitis
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Sinusitis
|
1.1%
4/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Upper respiratory tract infection
|
0.80%
3/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Urinary tract infection
|
1.3%
5/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Vaginal infection
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Contusion
|
0.80%
3/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Fall
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Wound
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Investigations
Alanine aminotransferase increased
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Investigations
Aspartate aminotransferase increased
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Investigations
Blood pressure increased
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Investigations
Blood uric acid increased
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Investigations
Hepatic enzyme increased
|
1.3%
5/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Investigations
Liver function test abnormal
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.80%
3/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
4/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
4/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Balance disorder
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Cognitive disorder
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Dizziness
|
14.9%
56/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Dizziness postural
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Headache
|
5.1%
19/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Memory impairment
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Migraine
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Sedation
|
1.1%
4/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Somnolence
|
11.4%
43/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Tremor
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Anxiety
|
0.80%
3/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Confusional state
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Cyclothymic disorder
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Disorientation
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Dysphoria
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Euphoric mood
|
1.1%
4/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Hypervigilance
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Insomnia
|
1.6%
6/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Middle insomnia
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Mood altered
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Sleep disorder
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Withdrawal syndrome
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Bladder discomfort
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Dysuria
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Leukocyturia
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Urinary hesitation
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Urine flow decreased
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
6/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.80%
3/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.2%
27/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.53%
2/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.27%
1/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Flushing
|
0.80%
3/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Hot flush
|
1.6%
6/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Hypertension
|
1.1%
4/376 • From screening to follow-up, up to 45 days
All treatment-emergent AEs are listed in the table of Other (Not Including Serious) Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place