A Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
Sponsor
Restorbio Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04668352
Collaborator
(none)
1,024
1
2
7.6
134.9
Study Details
Study Description
Brief Summary
To determine if RTB101 as compared to placebo decreases the percentage of subjects with clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen) through Week 16.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1024 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
Actual Study Start Date
:
Apr 15, 2019
Actual Primary Completion Date
:
Dec 2, 2019
Actual Study Completion Date
:
Dec 2, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dactolisib 10mg once daily
|
Drug: Dactolisib
TORC1 inhibitor
|
| Placebo Comparator: Placebo
|
Other: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With Clinically Symptomatic Respiratory Illness [Week 0-16]
To determine if RTB101 as compared to placebo decreases the percentage of subjects with clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen) through Week 16
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Written informed consent must be obtained before any assessment is performed.
-
Male and female subjects who, in the clinical judgement of the Investigator, are without unstable medical conditions defined as conditions that require acute medical intervention or ongoing adjustments of concomitant medications (as determined by medical history, current concomitant medications and laboratory test results at Screening, and physical examination, electrocardiogram (ECG) and vital signs at Screening and Baseline).
-
Subjects must be ≥65 years of age.
-
Subjects should require no or minimal assistance with self-care and activities of daily living. Subjects in assisted-living or long-term care residential facilities that provide minimal assistance are eligible.
-
Females must be post-menopausal. Women are considered postmenopausal and not of childbearing potential if they have had:
-
12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) OR
-
Surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks prior to Screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment will she be considered not of childbearing potential.
-
Sexually active male subjects with a partner of child-bearing potential must be willing to wear a condom while on study drug and for 1 week after stopping study drug and should not father a child in this period. A condom is required to be used also by vasectomized men with a partner of child-bearing potential to prevent delivery of the drug via seminal fluid.
-
Subject must weigh at least 40 kg.
-
Subject must be able to communicate well with the Investigator, and to understand and comply with the requirements of the study including completing a daily eDiary at home.
Exclusion Criteria:
- Any subject who:
-
Is a current smoker as assessed by medical history or a positive serum cotinine test (or positive urine cotinine test if serum cotinine testing is unavailable) at Screening. Stopped smoking ≤1 year prior to Screening.
-
Is a previous smoker with a ≥10 pack year smoking history. Has a household member who currently smokes in the house
-
Subjects with a medical history of clinically significant lung diseases other than asthma (e.g., chronic obstructive pulmonary disease (COPD), emphysema, interstitial pulmonary fibrosis (IPF), bronchiectasis, etc.).
-
Subjects with a Mini Mental Status Examination (MMSE) score <24 at Screening.
-
Subjects with current evidence of a serious and/or unstable medical disorder including cardiovascular, respiratory, gastrointestinal, renal (including subjects with an estimated glomerular filtration rate (eGFR) as estimated by the modified diet in renal disease (MDRD) GFR equation that is ≤30 mL/min/1.73m2), or hematologic disorders.
-
The following cardiac conditions:
-
Unstable angina pectoris or acute ischemic changes on ECG at Screening or Baseline
-
History of myocardial infarction (MI), coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Screening
-
New York Heart Association functional classification IIIIV congestive heart failure
-
Unstable or life-threatening cardiac arrhythmia, chronic stable atrial fibrillation is allowed.
-
QTcF>480 msec at Screening or Baseline
- Subjects with history of malignancy in any organ system within the past 5 years,
EXCEPT for the following:
-
Localized basal cell or squamous cell carcinoma of the skin.
-
Prostate cancer confined to the gland (AJCC stage T2N0M0 or better).
-
Cervical carcinoma in situ.
-
Breast cancer localized to the breast.
-
Any RTI or acute significant illness (based on the subject's medical history and the clinical judgement of the Investigator) which has not resolved at least two (2) weeks prior to Baseline.
-
Subjects with a history of systemic autoimmune diseases (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), or receiving immunosuppressive therapy (such as mycophenolate, tacrolimus, cyclosporine, azathioprine, infliximab) including chronic use of prednisone >10 mg daily (however, inhaled corticosteroids and the acute use of higher doses of prednisone to treat conditions such as exacerbation of asthma or other acute conditions are allowed).
-
Subjects with Type I diabetes mellitus.
-
Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further evaluation.
-
Subjects with any one of the following during Screening:
-
white blood cell (WBC) count <2.0 x103/microL.
-
neutrophil count <1.0 x 103/microL.
-
platelet count <75 x 103/microL..
-
Subjects with a history of alcohol or drug abuse within 2 years of the Screening visit.
-
Subjects with any conditions affecting absorption, distribution, or metabolism of the study drug (e.g., inflammatory bowel disease, gastric or duodenal ulcers, or hepatic disease). For subjects with biochemical evidence of liver injury as indicated by abnormal liver function tests:
-
Any single parameter of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase or serum bilirubin must not exceed 1.5 x upper limit of normal (ULN) in subjects who do not have Gilbert's syndrome. If the subject has a history of Gilbert's syndrome, direct and indirect reacting bilirubin should be differentiated, and the direct bilirubin must be less than 1.5 x ULN.
-
Any elevation above ULN of more than one parameter of ALT, AST, alkaline phosphatase or serum bilirubin will exclude a subject from participation in the study.
-
Subjects with a history of immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result.
-
Infection with Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
-
Subjects who require treatment with strong CYP3A4 or CYP1A2 inhibitors or inducers, or subjects who require treatment with digoxin.
-
Use of any other investigational medication or participation in any other investigational study within 5 half-lives of the investigational medication, or within 30 days, whichever is longer; or longer if required by local regulations.
-
Subjects who have received an organ transplant.
-
Subjects who previously received treatment with RTB101 in another clinical study (e.g., CBEZ235Y2201, RTB-BEZ235-202, or RTB-101-203).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | P3 Research Ltd. | Wellington | New Zealand |
Sponsors and Collaborators
- Restorbio Inc.
Investigators
- Principal Investigator: Dean Quinn, MD, P3 Research Ltd.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Restorbio Inc.
ClinicalTrials.gov Identifier:
NCT04668352
Other Study ID Numbers:
- RTB-101-204
First Posted:
Dec 16, 2020
Last Update Posted:
Jun 23, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | Dactolisib 10mg Once Daily |
|---|---|---|
| Arm/Group Description | Placebo: Placebo | Dactolisib: TORC1 inhibitor |
| Period Title: Overall Study | ||
| STARTED | 511 | 513 |
| COMPLETED | 510 | 511 |
| NOT COMPLETED | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Placebo | Dactolisib 10mg Once Daily | Total |
|---|---|---|---|
| Arm/Group Description | Placebo: Placebo | Dactolisib: TORC1 inhibitor | Total of all reporting groups |
| Overall Participants | 510 | 511 | 1021 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
73.1
(5.83)
|
72.6
(5.81)
|
72.8
(5.82)
|
| Age, Customized (Count of Participants) | |||
| >=65 and <85 years |
486
95.3%
|
488
95.5%
|
974
95.4%
|
| >=85 years |
24
4.7%
|
23
4.5%
|
47
4.6%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
286
56.1%
|
292
57.1%
|
578
56.6%
|
| Male |
224
43.9%
|
219
42.9%
|
443
43.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
7
1.4%
|
1
0.2%
|
8
0.8%
|
| Not Hispanic or Latino |
503
98.6%
|
510
99.8%
|
1013
99.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
4
0.8%
|
9
1.8%
|
13
1.3%
|
| Native Hawaiian or Other Pacific Islander |
8
1.6%
|
11
2.2%
|
19
1.9%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
498
97.6%
|
490
95.9%
|
988
96.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
1
0.2%
|
1
0.1%
|
| Region of Enrollment (participants) [Number] | |||
| New Zealand |
510
100%
|
511
100%
|
1021
100%
|
| Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
28.8
(5.13)
|
29.2
(5.47)
|
29.0
(5.31)
|
| Received Current Season Influenza Vaccination (Count of Participants) | |||
| Count of Participants [Participants] |
407
79.8%
|
415
81.2%
|
822
80.5%
|
Outcome Measures
| Title | Percentage of Subjects With Clinically Symptomatic Respiratory Illness |
|---|---|
| Description | To determine if RTB101 as compared to placebo decreases the percentage of subjects with clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen) through Week 16 |
| Time Frame | Week 0-16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Dactolisib 10mg Once Daily |
|---|---|---|
| Arm/Group Description | Placebo: Placebo | Dactolisib: TORC1 inhibitor |
| Measure Participants | 510 | 511 |
| Count of Participants [Participants] |
125
24.5%
|
134
26.2%
|
Adverse Events
| Time Frame | Up to Week 16 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Placebo | Dactolisib 10mg Once Daily | ||
| Arm/Group Description | Placebo: Placebo | Dactolisib: TORC1 inhibitor | ||
All Cause Mortality |
||||
| Placebo | Dactolisib 10mg Once Daily | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/510 (0%) | 1/511 (0.2%) | ||
Serious Adverse Events |
||||
| Placebo | Dactolisib 10mg Once Daily | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 32/510 (6.3%) | 31/511 (6.1%) | ||
| Blood and lymphatic system disorders | ||||
| Splenic embolism | 1/510 (0.2%) | 0/511 (0%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Atrial fibrillation | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Coronary artery dissection | 1/510 (0.2%) | 0/511 (0%) | ||
| Coronary artery stenosis | 1/510 (0.2%) | 0/511 (0%) | ||
| Myocardial infarction | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Ear and labyrinth disorders | ||||
| Meniere's disease | 1/510 (0.2%) | 0/511 (0%) | ||
| Eye disorders | ||||
| Cataract | 0/510 (0%) | 1/511 (0.2%) | ||
| Eye haemorrhage | 1/510 (0.2%) | 0/511 (0%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 1/510 (0.2%) | 0/511 (0%) | ||
| Pancreatitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Upper gastrointestinal haemorrhage | 0/510 (0%) | 1/511 (0.2%) | ||
| Volvulus | 1/510 (0.2%) | 0/511 (0%) | ||
| General disorders | ||||
| Fatigue | 1/510 (0.2%) | 0/511 (0%) | ||
| Oedema peripheral | 0/510 (0%) | 1/511 (0.2%) | ||
| Hepatobiliary disorders | ||||
| Bile duct obstruction | 1/510 (0.2%) | 0/511 (0%) | ||
| Infections and infestations | ||||
| Arthritis bacterial | 0/510 (0%) | 1/511 (0.2%) | ||
| Biliary sepsis | 1/510 (0.2%) | 0/511 (0%) | ||
| Cellulitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Gastroenteritis | 0/510 (0%) | 1/511 (0.2%) | ||
| Lower respiratory tract infection | 0/510 (0%) | 1/511 (0.2%) | ||
| Pneumonia | 2/510 (0.4%) | 0/511 (0%) | ||
| Sepsis | 1/510 (0.2%) | 0/511 (0%) | ||
| Urosepsis | 1/510 (0.2%) | 0/511 (0%) | ||
| Vestibular neuronitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Lower limb fracture | 1/510 (0.2%) | 0/511 (0%) | ||
| Road traffic accident | 1/510 (0.2%) | 0/511 (0%) | ||
| Soft tissue injury | 1/510 (0.2%) | 0/511 (0%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 0/510 (0%) | 1/511 (0.2%) | ||
| Metabolism and nutrition disorders | 1/510 (0.2%) | 0/511 (0%) | ||
| Hyponatraemia | 1/510 (0.2%) | 0/511 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/510 (0.2%) | 0/511 (0%) | ||
| Loose body in joint | 0/510 (0%) | 1/511 (0.2%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Adenocarcinoma pancreas | 1/510 (0.2%) | 0/511 (0%) | ||
| Basal cell carcinoma | 6/510 (1.2%) | 11/511 (2.2%) | ||
| Bladder cancer | 0/510 (0%) | 1/511 (0.2%) | ||
| Bowen's disease | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Breast cancer | 1/510 (0.2%) | 0/511 (0%) | ||
| Invasive lobular breast carcinoma | 1/510 (0.2%) | 0/511 (0%) | ||
| Malignant melanoma in situ | 0/510 (0%) | 1/511 (0.2%) | ||
| Metastases to bone | 0/510 (0%) | 1/511 (0.2%) | ||
| Squamous cell carcinoma | 0/510 (0%) | 2/511 (0.4%) | ||
| Squamous cell carcinoma of skin | 2/510 (0.4%) | 0/511 (0%) | ||
| Nervous system disorders | ||||
| Cerebral infarction | 1/510 (0.2%) | 0/511 (0%) | ||
| Cerebrovascular accident | 1/510 (0.2%) | 0/511 (0%) | ||
| Dizziness | 0/510 (0%) | 1/511 (0.2%) | ||
| Haemorrhage intracranial | 0/510 (0%) | 1/511 (0.2%) | ||
| Migraine | 1/510 (0.2%) | 0/511 (0%) | ||
| Normal pressure hydrocephalus | 0/510 (0%) | 1/511 (0.2%) | ||
| Presyncope | 1/510 (0.2%) | 0/511 (0%) | ||
| Syncope | 2/510 (0.4%) | 0/511 (0%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 1/510 (0.2%) | 0/511 (0%) | ||
| Renal embolism | 1/510 (0.2%) | 0/511 (0%) | ||
| Urinary retention | 1/510 (0.2%) | 0/511 (0%) | ||
| Reproductive system and breast disorders | ||||
| Uterine polyp | 1/510 (0.2%) | 0/511 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 0/510 (0%) | 2/511 (0.4%) | ||
| Rales | 0/510 (0%) | 1/511 (0.2%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Skin lesion | 1/510 (0.2%) | 0/511 (0%) | ||
| Surgical and medical procedures | ||||
| Cancer surgery | 1/510 (0.2%) | 0/511 (0%) | ||
| Vascular disorders | ||||
| Hypertension | 0/510 (0%) | 1/511 (0.2%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo | Dactolisib 10mg Once Daily | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 371/510 (72.7%) | 386/511 (75.5%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 7/510 (1.4%) | 7/511 (1.4%) | ||
| Iron deficiency anaemia | 2/510 (0.4%) | 3/511 (0.6%) | ||
| Leukopenia | 0/510 (0%) | 1/511 (0.2%) | ||
| Lymphadenopathy | 1/510 (0.2%) | 0/511 (0%) | ||
| Neutropenia | 1/510 (0.2%) | 0/511 (0%) | ||
| Splenic embolism | 1/510 (0.2%) | 3/511 (0.6%) | ||
| Splenic infarction | 1/510 (0.2%) | 0/511 (0%) | ||
| Thrombocytopenia | 1/510 (0.2%) | 0/511 (0%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 19/510 (3.7%) | 16/511 (3.1%) | ||
| Angina pectoris | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Atrial fibrillation | 0/510 (0%) | 1/511 (0.2%) | ||
| Atrial flutter | 10/510 (2%) | 6/511 (1.2%) | ||
| Bradycardia | 1/510 (0.2%) | 0/511 (0%) | ||
| Cardiac failure congestive | 0/510 (0%) | 1/511 (0.2%) | ||
| Coronary artery dissection | 1/510 (0.2%) | 0/511 (0%) | ||
| Coronary artery stenosis | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Extrasystoles | 0/510 (0%) | 1/511 (0.2%) | ||
| Myocardial infarction | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Palpitations | 4/510 (0.8%) | 4/511 (0.8%) | ||
| Sinus tachycardia | 1/510 (0.2%) | 0/511 (0%) | ||
| Supraventricular extrasystoles | 1/510 (0.2%) | 0/511 (0%) | ||
| Supraventricular tachycardia | 1/510 (0.2%) | 0/511 (0%) | ||
| Tachycardia | 0/510 (0%) | 1/511 (0.2%) | ||
| Ventricular extrasystoles | 1/510 (0.2%) | 0/511 (0%) | ||
| Ear and labyrinth disorders | ||||
| Cerumen impaction | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Ear pain | 0/510 (0%) | 3/511 (0.6%) | ||
| Eustachian tube dysfunction | 1/510 (0.2%) | 0/511 (0%) | ||
| Eustachian tube obstruction | 0/510 (0%) | 1/511 (0.2%) | ||
| Excessive cerumen production | 0/510 (0%) | 2/511 (0.4%) | ||
| Meniere's disease | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Motion sickness | 1/510 (0.2%) | 0/511 (0%) | ||
| Sudden hearing loss | 1/510 (0.2%) | 0/511 (0%) | ||
| Tinnitus | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Vertigo | 4/510 (0.8%) | 2/511 (0.4%) | ||
| Vertigo positional | 1/510 (0.2%) | 3/511 (0.6%) | ||
| Endocrine disorders | ||||
| Hypothyroidism | 0/510 (0%) | 1/511 (0.2%) | ||
| Eye disorders | ||||
| Amaurosis fugax | 0/510 (0%) | 1/511 (0.2%) | ||
| Blepharitis | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Cataract | 1/510 (0.2%) | 2/511 (0.4%) | ||
| Conjunctival haemorrhage | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Dry eye | 0/510 (0%) | 2/511 (0.4%) | ||
| Episcleritis | 0/510 (0%) | 1/511 (0.2%) | ||
| Eye discharge | 0/510 (0%) | 1/511 (0.2%) | ||
| Eye haemorrhage | 1/510 (0.2%) | 0/511 (0%) | ||
| Eye pain | 0/510 (0%) | 1/511 (0.2%) | ||
| Eye pruritus | 1/510 (0.2%) | 0/511 (0%) | ||
| Eyelid haematoma | 0/510 (0%) | 1/511 (0.2%) | ||
| Glaucoma | 0/510 (0%) | 1/511 (0.2%) | ||
| Keratoconus | 0/510 (0%) | 1/511 (0.2%) | ||
| Lacrimation increased | 2/510 (0.4%) | 0/511 (0%) | ||
| Macular degeneration | 1/510 (0.2%) | 0/511 (0%) | ||
| Myopia | 0/510 (0%) | 1/511 (0.2%) | ||
| Photophobia | 0/510 (0%) | 1/511 (0.2%) | ||
| Retinal haemorrhage | 1/510 (0.2%) | 0/511 (0%) | ||
| Scleritis | 0/510 (0%) | 1/511 (0.2%) | ||
| Visual impairment | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Vitreous detachment | 0/510 (0%) | 2/511 (0.4%) | ||
| Vitreous floaters | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Gastrointestinal disorders | ||||
| Anal haemorrhage | 0/510 (0%) | 1/511 (0.2%) | ||
| Anal incontinence | 1/510 (0.2%) | 0/511 (0%) | ||
| Anal pruritus | 0/510 (0%) | 1/511 (0.2%) | ||
| Aphthous ulcer | 0/510 (0%) | 3/511 (0.6%) | ||
| Change of bowel habit | 2/510 (0.4%) | 0/511 (0%) | ||
| Colitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Constipation | 6/510 (1.2%) | 6/511 (1.2%) | ||
| Dental caries | 2/510 (0.4%) | 3/511 (0.6%) | ||
| Diarrhoea | 34/510 (6.7%) | 35/511 (6.8%) | ||
| Diarrhoea haemorrhagic | 1/510 (0.2%) | 0/511 (0%) | ||
| Discoloured vomit | 1/510 (0.2%) | 0/511 (0%) | ||
| Diverticulum | 2/510 (0.4%) | 0/511 (0%) | ||
| Dry mouth | 2/510 (0.4%) | 5/511 (1%) | ||
| Dyspepsia | 1/510 (0.2%) | 5/511 (1%) | ||
| Dysphagia | 1/510 (0.2%) | 0/511 (0%) | ||
| Eructation | 1/510 (0.2%) | 0/511 (0%) | ||
| Faeces discoloured | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Faeces hard | 0/510 (0%) | 1/511 (0.2%) | ||
| Faeces soft | 0/510 (0%) | 2/511 (0.4%) | ||
| Flatulence | 3/510 (0.6%) | 3/511 (0.6%) | ||
| Food poisoning | 0/510 (0%) | 1/511 (0.2%) | ||
| Gastritis | 1/510 (0.2%) | 2/511 (0.4%) | ||
| Gastrointestinal disorder | 0/510 (0%) | 1/511 (0.2%) | ||
| Gastrooesophageal reflux disease | 7/510 (1.4%) | 5/511 (1%) | ||
| Gingival bleeding | 0/510 (0%) | 1/511 (0.2%) | ||
| Glossodynia | 0/510 (0%) | 2/511 (0.4%) | ||
| Haematochezia | 2/510 (0.4%) | 0/511 (0%) | ||
| Haemorrhoids | 1/510 (0.2%) | 0/511 (0%) | ||
| Inguinal hernia | 2/510 (0.4%) | 0/511 (0%) | ||
| Large intestine polyp | 1/510 (0.2%) | 0/511 (0%) | ||
| Lip blister | 1/510 (0.2%) | 0/511 (0%) | ||
| Lip pain | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Lip ulceration | 2/510 (0.4%) | 6/511 (1.2%) | ||
| Mouth ulceration | 6/510 (1.2%) | 9/511 (1.8%) | ||
| Nausea | 11/510 (2.2%) | 7/511 (1.4%) | ||
| Oral discomfort | 1/510 (0.2%) | 0/511 (0%) | ||
| Pancreatitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Rectal haemorrhage | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Stomatitis | 2/510 (0.4%) | 3/511 (0.6%) | ||
| Tongue disorder | 2/510 (0.4%) | 0/511 (0%) | ||
| Tongue erythema | 0/510 (0%) | 1/511 (0.2%) | ||
| Tongue ulceration | 1/510 (0.2%) | 0/511 (0%) | ||
| Tooth loss | 1/510 (0.2%) | 0/511 (0%) | ||
| Toothache | 1/510 (0.2%) | 5/511 (1%) | ||
| Umbilical hernia | 0/510 (0%) | 1/511 (0.2%) | ||
| Upper gastrointestinal haemorrhage | 0/510 (0%) | 1/511 (0.2%) | ||
| Uvulitis | 0/510 (0%) | 1/511 (0.2%) | ||
| Volvulus | 1/510 (0.2%) | 0/511 (0%) | ||
| Vomiting | 9/510 (1.8%) | 4/511 (0.8%) | ||
| General disorders | ||||
| Adverse drug reaction | 0/510 (0%) | 1/511 (0.2%) | ||
| Application site erosion | 0/510 (0%) | 1/511 (0.2%) | ||
| Application site rash | 0/510 (0%) | 1/511 (0.2%) | ||
| Asthenia | 7/510 (1.4%) | 9/511 (1.8%) | ||
| Chest discomfort | 3/510 (0.6%) | 0/511 (0%) | ||
| Chest pain | 6/510 (1.2%) | 5/511 (1%) | ||
| Chills | 1/510 (0.2%) | 4/511 (0.8%) | ||
| Drug intolerance | 1/510 (0.2%) | 0/511 (0%) | ||
| Facial pain | 0/510 (0%) | 1/511 (0.2%) | ||
| Fatigue | 11/510 (2.2%) | 12/511 (2.3%) | ||
| Influenza like illness | 0/510 (0%) | 1/511 (0.2%) | ||
| Malaise | 2/510 (0.4%) | 0/511 (0%) | ||
| Medical device pain | 0/510 (0%) | 1/511 (0.2%) | ||
| Non-cardiac chest pain | 0/510 (0%) | 2/511 (0.4%) | ||
| Oedema peripheral | 3/510 (0.6%) | 4/511 (0.8%) | ||
| Pain | 8/510 (1.6%) | 5/511 (1%) | ||
| Peripheral swelling | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Pyrexia | 3/510 (0.6%) | 1/511 (0.2%) | ||
| Therapeutic response unexpected | 59/510 (11.6%) | 66/511 (12.9%) | ||
| Vessel puncture site bruise | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Hepatobiliary disorders | ||||
| Bile duct obstruction | 1/510 (0.2%) | 0/511 (0%) | ||
| Cholelithiasis | 0/510 (0%) | 1/511 (0.2%) | ||
| Hepatic steatosis | 0/510 (0%) | 1/511 (0.2%) | ||
| Immune system disorders | ||||
| Allergy to plants | 0/510 (0%) | 1/511 (0.2%) | ||
| Drug hypersensitivity | 0/510 (0%) | 1/511 (0.2%) | ||
| Seasonal allergy | 9/510 (1.8%) | 2/511 (0.4%) | ||
| Infections and infestations | ||||
| Abscess limb | 1/510 (0.2%) | 0/511 (0%) | ||
| Acute sinusitis | 0/510 (0%) | 1/511 (0.2%) | ||
| Anal candidiasis | 0/510 (0%) | 1/511 (0.2%) | ||
| Arthritis bacterial | 0/510 (0%) | 1/511 (0.2%) | ||
| Bacteriuria | 1/510 (0.2%) | 0/511 (0%) | ||
| Biliary sepsis | 1/510 (0.2%) | 0/511 (0%) | ||
| Bronchitis | 1/510 (0.2%) | 5/511 (1%) | ||
| Bursitis infective | 0/510 (0%) | 1/511 (0.2%) | ||
| Campylobacter gastroenteritis | 0/510 (0%) | 1/511 (0.2%) | ||
| Candida infection | 0/510 (0%) | 1/511 (0.2%) | ||
| Cellulitis | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Conjunctivitis | 1/510 (0.2%) | 5/511 (1%) | ||
| Corona virus infection | 1/510 (0.2%) | 0/511 (0%) | ||
| Cystitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Diverticulitis | 2/510 (0.4%) | 4/511 (0.8%) | ||
| Ear infection | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Folliculitis | 0/510 (0%) | 1/511 (0.2%) | ||
| Fungal skin infection | 2/510 (0.4%) | 3/511 (0.6%) | ||
| Furuncle | 2/510 (0.4%) | 3/511 (0.6%) | ||
| Gastroenteritis | 9/510 (1.8%) | 9/511 (1.8%) | ||
| Gastroenteritis viral | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Genital herpes | 1/510 (0.2%) | 0/511 (0%) | ||
| Gingivitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Herpes zoster | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Hordeolum | 0/510 (0%) | 1/511 (0.2%) | ||
| Infected bite | 0/510 (0%) | 1/511 (0.2%) | ||
| Infected dermal cyst | 1/510 (0.2%) | 0/511 (0%) | ||
| Laryngitis | 0/510 (0%) | 1/511 (0.2%) | ||
| Lice infestation | 1/510 (0.2%) | 0/511 (0%) | ||
| Lip infection | 1/510 (0.2%) | 0/511 (0%) | ||
| Localised infection | 4/510 (0.8%) | 3/511 (0.6%) | ||
| Lower respiratory tract infection | 0/510 (0%) | 1/511 (0.2%) | ||
| Lower respiratory tract infection bacterial | 0/510 (0%) | 1/511 (0.2%) | ||
| Medical device site infection | 1/510 (0.2%) | 0/511 (0%) | ||
| Nail infection | 0/510 (0%) | 1/511 (0.2%) | ||
| Nasal herpes | 1/510 (0.2%) | 0/511 (0%) | ||
| Onychomycosis | 0/510 (0%) | 2/511 (0.4%) | ||
| Oral candidiasis | 1/510 (0.2%) | 2/511 (0.4%) | ||
| Oral herpes | 16/510 (3.1%) | 7/511 (1.4%) | ||
| Otitis externa | 4/510 (0.8%) | 4/511 (0.8%) | ||
| Otitis media | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Paronychia | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Periodontitis | 0/510 (0%) | 1/511 (0.2%) | ||
| Pertussis | 1/510 (0.2%) | 0/511 (0%) | ||
| Pneumonia | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Postoperative wound infection | 1/510 (0.2%) | 0/511 (0%) | ||
| Rhinitis | 5/510 (1%) | 2/511 (0.4%) | ||
| Root canal infection | 2/510 (0.4%) | 0/511 (0%) | ||
| Sepsis | 1/510 (0.2%) | 0/511 (0%) | ||
| Sinusitis | 2/510 (0.4%) | 6/511 (1.2%) | ||
| Skin infection | 0/510 (0%) | 5/511 (1%) | ||
| Staphylococcal infection | 0/510 (0%) | 1/511 (0.2%) | ||
| Subcutaneous abscess | 0/510 (0%) | 1/511 (0.2%) | ||
| Tinea pedis | 0/510 (0%) | 1/511 (0.2%) | ||
| Tonsillitis | 0/510 (0%) | 2/511 (0.4%) | ||
| Tooth abscess | 4/510 (0.8%) | 0/511 (0%) | ||
| Tooth infection | 2/510 (0.4%) | 6/511 (1.2%) | ||
| Upper respiratory tract infection | 1/510 (0.2%) | 0/511 (0%) | ||
| Urinary tract infection | 21/510 (4.1%) | 15/511 (2.9%) | ||
| Urosepsis | 1/510 (0.2%) | 0/511 (0%) | ||
| Vestibular neuronitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Viral infection | 3/510 (0.6%) | 2/511 (0.4%) | ||
| Viral rash | 1/510 (0.2%) | 0/511 (0%) | ||
| Viral rhinitis | 0/510 (0%) | 1/511 (0.2%) | ||
| Vulvovaginal candidiasis | 1/510 (0.2%) | 2/511 (0.4%) | ||
| Wound infection | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Anaemia postoperative | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Anal injury | 0/510 (0%) | 1/511 (0.2%) | ||
| Animal bite | 2/510 (0.4%) | 0/511 (0%) | ||
| Animal scratch | 0/510 (0%) | 2/511 (0.4%) | ||
| Ankle fracture | 1/510 (0.2%) | 0/511 (0%) | ||
| Arthropod bite | 1/510 (0.2%) | 3/511 (0.6%) | ||
| Arthropod sting | 0/510 (0%) | 1/511 (0.2%) | ||
| Back injury | 1/510 (0.2%) | 0/511 (0%) | ||
| Chest injury | 2/510 (0.4%) | 0/511 (0%) | ||
| Chillblains | 0/510 (0%) | 1/511 (0.2%) | ||
| Contusion | 10/510 (2%) | 22/511 (4.3%) | ||
| Corneal abrasion | 1/510 (0.2%) | 0/511 (0%) | ||
| Dental restoration failure | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Extra dose administered | 1/510 (0.2%) | 0/511 (0%) | ||
| Eyelid injury | 0/510 (0%) | 1/511 (0.2%) | ||
| Fall | 28/510 (5.5%) | 20/511 (3.9%) | ||
| Foot fracture | 0/510 (0%) | 2/511 (0.4%) | ||
| Foreign body | 1/510 (0.2%) | 0/511 (0%) | ||
| Foreign body in eye | 0/510 (0%) | 1/511 (0.2%) | ||
| Hand fracture | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Joint dislocation | 1/510 (0.2%) | 0/511 (0%) | ||
| Joint injury | 3/510 (0.6%) | 2/511 (0.4%) | ||
| Ligament rupture | 3/510 (0.6%) | 1/511 (0.2%) | ||
| Ligament sprain | 7/510 (1.4%) | 10/511 (2%) | ||
| Limb injury | 1/510 (0.2%) | 2/511 (0.4%) | ||
| Lip injury | 1/510 (0.2%) | 0/511 (0%) | ||
| Lower limb fracture | 1/510 (0.2%) | 0/511 (0%) | ||
| Lumbar vertebral fracture | 1/510 (0.2%) | 0/511 (0%) | ||
| Meniscus injury | 1/510 (0.2%) | 0/511 (0%) | ||
| Mouth injury | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Muscle rupture | 1/510 (0.2%) | 2/511 (0.4%) | ||
| Muscle strain | 10/510 (2%) | 16/511 (3.1%) | ||
| Musculoskeletal injury | 0/510 (0%) | 1/511 (0.2%) | ||
| Nail avulsion | 0/510 (0%) | 1/511 (0.2%) | ||
| Nail injury | 0/510 (0%) | 1/511 (0.2%) | ||
| Palate injury | 1/510 (0.2%) | 0/511 (0%) | ||
| Periorbital haematoma | 0/510 (0%) | 1/511 (0.2%) | ||
| Pharyngeal injury | 1/510 (0.2%) | 0/511 (0%) | ||
| Post concussion syndrome | 1/510 (0.2%) | 0/511 (0%) | ||
| Post procedural constipation | 1/510 (0.2%) | 0/511 (0%) | ||
| Post procedural discharge | 1/510 (0.2%) | 0/511 (0%) | ||
| Post-traumatic pain | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Procedural pain | 5/510 (1%) | 3/511 (0.6%) | ||
| Repetitive strain injury | 1/510 (0.2%) | 0/511 (0%) | ||
| Rib fracture | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Road traffic accident | 1/510 (0.2%) | 0/511 (0%) | ||
| Scratch | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Seroma | 0/510 (0%) | 1/511 (0.2%) | ||
| Skin abrasion | 14/510 (2.7%) | 21/511 (4.1%) | ||
| Skin injury | 1/510 (0.2%) | 0/511 (0%) | ||
| Skin laceration | 8/510 (1.6%) | 11/511 (2.2%) | ||
| Skin wound | 0/510 (0%) | 1/511 (0.2%) | ||
| Soft tissue injury | 2/510 (0.4%) | 0/511 (0%) | ||
| Subcutaneous haematoma | 0/510 (0%) | 1/511 (0.2%) | ||
| Sunburn | 1/510 (0.2%) | 0/511 (0%) | ||
| Tendon injury | 0/510 (0%) | 1/511 (0.2%) | ||
| Thermal burn | 3/510 (0.6%) | 1/511 (0.2%) | ||
| Tooth fracture | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Traumatic haematoma | 0/510 (0%) | 2/511 (0.4%) | ||
| Upper limb fracture | 0/510 (0%) | 1/511 (0.2%) | ||
| Wound | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Biopsy skin | 0/510 (0%) | 1/511 (0.2%) | ||
| Blood alkaline phosphatase increased | 1/510 (0.2%) | 3/511 (0.6%) | ||
| Blood bilirubin increased | 0/510 (0%) | 1/511 (0.2%) | ||
| Blood creatinine increased | 0/510 (0%) | 1/511 (0.2%) | ||
| Blood glucose decreased | 0/510 (0%) | 1/511 (0.2%) | ||
| Blood glucose increased | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Blood potassium increased | 0/510 (0%) | 5/511 (1%) | ||
| Blood pressure increased | 2/510 (0.4%) | 3/511 (0.6%) | ||
| Cardiac murmur | 3/510 (0.6%) | 2/511 (0.4%) | ||
| Electrocardiogram QT prolonged | 3/510 (0.6%) | 7/511 (1.4%) | ||
| Electrocardiogram ST segment elevation | 1/510 (0.2%) | 0/511 (0%) | ||
| Eosinophil count increased | 1/510 (0.2%) | 0/511 (0%) | ||
| Faecal volume increased | 1/510 (0.2%) | 0/511 (0%) | ||
| Fibrin D dimer increased | 1/510 (0.2%) | 0/511 (0%) | ||
| Glomerular filtration rate decreased | 2/510 (0.4%) | 3/511 (0.6%) | ||
| Glycosylated haemoglobin increased | 0/510 (0%) | 1/511 (0.2%) | ||
| Haematocrit increased | 0/510 (0%) | 1/511 (0.2%) | ||
| Haemoglobin decreased | 1/510 (0.2%) | 5/511 (1%) | ||
| Hepatic enzyme increased | 0/510 (0%) | 1/511 (0.2%) | ||
| Laboratory test abnormal | 0/510 (0%) | 1/511 (0.2%) | ||
| Liver function test abnormal | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Liver function test increased | 1/510 (0.2%) | 0/511 (0%) | ||
| Neutrophil count decreased | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Occult blood positive | 0/510 (0%) | 1/511 (0.2%) | ||
| Platelet count decreased | 1/510 (0.2%) | 0/511 (0%) | ||
| Platelet count increased | 1/510 (0.2%) | 0/511 (0%) | ||
| Prostatic specific antigen increased | 2/510 (0.4%) | 0/511 (0%) | ||
| Red blood cells urine positive | 0/510 (0%) | 1/511 (0.2%) | ||
| Renal function test abnormal | 0/510 (0%) | 1/511 (0.2%) | ||
| Transaminases increased | 0/510 (0%) | 2/511 (0.4%) | ||
| Urinary sediment present | 0/510 (0%) | 1/511 (0.2%) | ||
| Urine albumin/creatinine ratio increased | 0/510 (0%) | 1/511 (0.2%) | ||
| Vitamin B12 decreased | 1/510 (0.2%) | 0/511 (0%) | ||
| Vitamin D decreased | 1/510 (0.2%) | 0/511 (0%) | ||
| Weight decreased | 0/510 (0%) | 1/511 (0.2%) | ||
| Weight increased | 2/510 (0.4%) | 1/511 (0.2%) | ||
| White blood cell count increased | 1/510 (0.2%) | 0/511 (0%) | ||
| White blood cells urine positive | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 2/510 (0.4%) | 7/511 (1.4%) | ||
| Diabetes mellitus | 1/510 (0.2%) | 0/511 (0%) | ||
| Fluid overload | 1/510 (0.2%) | 0/511 (0%) | ||
| Fluid retention | 0/510 (0%) | 2/511 (0.4%) | ||
| Gout | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Hypercholesterolaemia | 0/510 (0%) | 3/511 (0.6%) | ||
| Hyperglycaemia | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Hyperkalaemia | 0/510 (0%) | 1/511 (0.2%) | ||
| Hypoglycaemia | 1/510 (0.2%) | 0/511 (0%) | ||
| Hypokalaemia | 4/510 (0.8%) | 0/511 (0%) | ||
| Hyponatraemia | 3/510 (0.6%) | 0/511 (0%) | ||
| Increased appetite | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Iron deficiency | 0/510 (0%) | 1/511 (0.2%) | ||
| Salt craving | 0/510 (0%) | 1/511 (0.2%) | ||
| Type 2 diabetes mellitus | 1/510 (0.2%) | 4/511 (0.8%) | ||
| Vitamin B12 deficiency | 0/510 (0%) | 1/511 (0.2%) | ||
| Vitamin D deficiency | 0/510 (0%) | 1/511 (0.2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 12/510 (2.4%) | 21/511 (4.1%) | ||
| Arthritis | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Back pain | 15/510 (2.9%) | 11/511 (2.2%) | ||
| Bursitis | 5/510 (1%) | 4/511 (0.8%) | ||
| Chondrocalcinosis pyrophosphate | 1/510 (0.2%) | 0/511 (0%) | ||
| Fibromyalgia | 0/510 (0%) | 1/511 (0.2%) | ||
| Groin pain | 0/510 (0%) | 1/511 (0.2%) | ||
| Inguinal mass | 0/510 (0%) | 1/511 (0.2%) | ||
| Intervertebral disc disorder | 0/510 (0%) | 1/511 (0.2%) | ||
| Intervertebral disc protrusion | 0/510 (0%) | 1/511 (0.2%) | ||
| Joint effusion | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Joint range of motion decreased | 1/510 (0.2%) | 0/511 (0%) | ||
| Joint stiffness | 0/510 (0%) | 1/511 (0.2%) | ||
| Joint swelling | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Limb mass | 0/510 (0%) | 1/511 (0.2%) | ||
| Loose body in joint | 0/510 (0%) | 1/511 (0.2%) | ||
| Metatarsalgia | 1/510 (0.2%) | 0/511 (0%) | ||
| Muscle spasms | 5/510 (1%) | 9/511 (1.8%) | ||
| Muscle tightness | 0/510 (0%) | 1/511 (0.2%) | ||
| Muscle twitching | 0/510 (0%) | 1/511 (0.2%) | ||
| Muscular weakness | 0/510 (0%) | 1/511 (0.2%) | ||
| Musculoskeletal chest pain | 5/510 (1%) | 1/511 (0.2%) | ||
| Musculoskeletal discomfort | 4/510 (0.8%) | 2/511 (0.4%) | ||
| Musculoskeletal pain | 5/510 (1%) | 7/511 (1.4%) | ||
| Myalgia | 0/510 (0%) | 6/511 (1.2%) | ||
| Myositis | 0/510 (0%) | 1/511 (0.2%) | ||
| Neck pain | 3/510 (0.6%) | 4/511 (0.8%) | ||
| Osteoarthritis | 4/510 (0.8%) | 6/511 (1.2%) | ||
| Osteopenia | 0/510 (0%) | 1/511 (0.2%) | ||
| Osteoporosis | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Pain in extremity | 8/510 (1.6%) | 13/511 (2.5%) | ||
| Periarthritis | 0/510 (0%) | 1/511 (0.2%) | ||
| Plantar fasciitis | 0/510 (0%) | 3/511 (0.6%) | ||
| Rotator cuff syndrome | 4/510 (0.8%) | 2/511 (0.4%) | ||
| Spinal osteoarthritis | 0/510 (0%) | 1/511 (0.2%) | ||
| Spinal pain | 0/510 (0%) | 1/511 (0.2%) | ||
| Temporomandibular joint syndrome | 0/510 (0%) | 1/511 (0.2%) | ||
| Tendonitis | 0/510 (0%) | 3/511 (0.6%) | ||
| Tenosynovitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Torticollis | 0/510 (0%) | 1/511 (0.2%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acrochordon | 0/510 (0%) | 1/511 (0.2%) | ||
| Adenocarcinoma pancreas | 1/510 (0.2%) | 0/511 (0%) | ||
| Basal cell carcinoma | 6/510 (1.2%) | 11/511 (2.2%) | ||
| Bladder cancer | 0/510 (0%) | 1/511 (0.2%) | ||
| Bowen's disease | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Breast cancer | 1/510 (0.2%) | 0/511 (0%) | ||
| Fibrous histiocytoma | 0/510 (0%) | 1/511 (0.2%) | ||
| Invasive lobular breast carcinoma | 1/510 (0.2%) | 0/511 (0%) | ||
| Keratoacanthoma | 0/510 (0%) | 1/511 (0.2%) | ||
| Lipoma | 0/510 (0%) | 1/511 (0.2%) | ||
| Malignant melanoma in situ | 0/510 (0%) | 1/511 (0.2%) | ||
| Melanocytic naevus | 1/510 (0.2%) | 0/511 (0%) | ||
| Metastases to bone | 0/510 (0%) | 1/511 (0.2%) | ||
| Oral neoplasm | 0/510 (0%) | 1/511 (0.2%) | ||
| Seborrhoeic keratosis | 4/510 (0.8%) | 4/511 (0.8%) | ||
| Skin papilloma | 0/510 (0%) | 1/511 (0.2%) | ||
| Squamous cell carcinoma | 0/510 (0%) | 2/511 (0.4%) | ||
| Squamous cell carcinoma of skin | 2/510 (0.4%) | 0/511 (0%) | ||
| Nervous system disorders | ||||
| Amnesia | 2/510 (0.4%) | 0/511 (0%) | ||
| Aphonia | 0/510 (0%) | 1/511 (0.2%) | ||
| Balance disorder | 1/510 (0.2%) | 0/511 (0%) | ||
| Carpal tunnel syndrome | 0/510 (0%) | 2/511 (0.4%) | ||
| Cerebral infarction | 1/510 (0.2%) | 0/511 (0%) | ||
| Cerebrovascular accident | 1/510 (0.2%) | 0/511 (0%) | ||
| Circadian rhythm sleep disorder | 0/510 (0%) | 1/511 (0.2%) | ||
| Cognitive disorder | 0/510 (0%) | 1/511 (0.2%) | ||
| Dizziness | 13/510 (2.5%) | 13/511 (2.5%) | ||
| Dizziness postural | 1/510 (0.2%) | 0/511 (0%) | ||
| Dysaesthesia | 0/510 (0%) | 1/511 (0.2%) | ||
| Dyskinesia | 0/510 (0%) | 1/511 (0.2%) | ||
| Facial neuralgia | 0/510 (0%) | 1/511 (0.2%) | ||
| Haemorrhage intracranial | 0/510 (0%) | 1/511 (0.2%) | ||
| Head discomfort | 0/510 (0%) | 1/511 (0.2%) | ||
| Headache | 26/510 (5.1%) | 37/511 (7.2%) | ||
| Hypoaesthesia | 0/510 (0%) | 1/511 (0.2%) | ||
| Hyposmia | 0/510 (0%) | 1/511 (0.2%) | ||
| Lethargy | 6/510 (1.2%) | 9/511 (1.8%) | ||
| Mental impairment | 0/510 (0%) | 1/511 (0.2%) | ||
| Migraine | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Migraine with aura | 0/510 (0%) | 1/511 (0.2%) | ||
| Neuralgia | 0/510 (0%) | 2/511 (0.4%) | ||
| Normal pressure hydrocephalus | 0/510 (0%) | 1/511 (0.2%) | ||
| Paraesthesia | 4/510 (0.8%) | 3/511 (0.6%) | ||
| Presyncope | 2/510 (0.4%) | 3/511 (0.6%) | ||
| Sciatica | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Sedation | 1/510 (0.2%) | 0/511 (0%) | ||
| Somnolence | 1/510 (0.2%) | 2/511 (0.4%) | ||
| Syncope | 5/510 (1%) | 0/511 (0%) | ||
| Tension headache | 0/510 (0%) | 1/511 (0.2%) | ||
| Transient ischaemic attack | 0/510 (0%) | 1/511 (0.2%) | ||
| Tremor | 0/510 (0%) | 1/511 (0.2%) | ||
| Trigeminal neuralgia | 0/510 (0%) | 1/511 (0.2%) | ||
| Vascular parkinsonism | 1/510 (0.2%) | 0/511 (0%) | ||
| Product Issues | ||||
| Device breakage | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Psychiatric disorders | ||||
| Abnormal dreams | 0/510 (0%) | 1/511 (0.2%) | ||
| Anxiety | 1/510 (0.2%) | 4/511 (0.8%) | ||
| Apathy | 1/510 (0.2%) | 0/511 (0%) | ||
| Delirium | 0/510 (0%) | 1/511 (0.2%) | ||
| Depressed mood | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Depression | 1/510 (0.2%) | 3/511 (0.6%) | ||
| Insomnia | 4/510 (0.8%) | 3/511 (0.6%) | ||
| Renal and urinary disorders | ||||
| Acute kidney injury | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Dysuria | 0/510 (0%) | 2/511 (0.4%) | ||
| Haematuria | 3/510 (0.6%) | 2/511 (0.4%) | ||
| Hydronephrosis | 1/510 (0.2%) | 0/511 (0%) | ||
| Hypertonic bladder | 1/510 (0.2%) | 0/511 (0%) | ||
| Incontinence | 0/510 (0%) | 1/511 (0.2%) | ||
| Lower urinary tract symptoms | 0/510 (0%) | 1/511 (0.2%) | ||
| Nephrolithiasis | 0/510 (0%) | 1/511 (0.2%) | ||
| Nocturia | 0/510 (0%) | 2/511 (0.4%) | ||
| Pollakiuria | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Renal cyst | 0/510 (0%) | 2/511 (0.4%) | ||
| Renal embolism | 1/510 (0.2%) | 0/511 (0%) | ||
| Renal impairment | 5/510 (1%) | 4/511 (0.8%) | ||
| Renal infarct | 1/510 (0.2%) | 0/511 (0%) | ||
| Urethral stenosis | 0/510 (0%) | 1/511 (0.2%) | ||
| Urinary retention | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Urinary tract discomfort | 1/510 (0.2%) | 0/511 (0%) | ||
| Urinary tract obstruction | 1/510 (0.2%) | 0/511 (0%) | ||
| Urine odour abnormal | 0/510 (0%) | 1/511 (0.2%) | ||
| Reproductive system and breast disorders | ||||
| Atrophic vulvovaginitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Benign prostatic hyperplasia | 1/510 (0.2%) | 0/511 (0%) | ||
| Erectile dysfunction | 2/510 (0.4%) | 0/511 (0%) | ||
| Prostatitis | 1/510 (0.2%) | 0/511 (0%) | ||
| Prostatomegaly | 1/510 (0.2%) | 0/511 (0%) | ||
| Uterine polyp | 1/510 (0.2%) | 0/511 (0%) | ||
| Vaginal discharge | 0/510 (0%) | 1/511 (0.2%) | ||
| Vaginal haemorrhage | 1/510 (0.2%) | 0/511 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 12/510 (2.4%) | 18/511 (3.5%) | ||
| Bronchiectasis | 1/510 (0.2%) | 0/511 (0%) | ||
| Choking | 1/510 (0.2%) | 0/511 (0%) | ||
| Cough | 4/510 (0.8%) | 2/511 (0.4%) | ||
| Dysphonia | 4/510 (0.8%) | 0/511 (0%) | ||
| Dyspnoea | 3/510 (0.6%) | 7/511 (1.4%) | ||
| Dyspnoea exertional | 1/510 (0.2%) | 2/511 (0.4%) | ||
| Epistaxis | 12/510 (2.4%) | 9/511 (1.8%) | ||
| Haemoptysis | 0/510 (0%) | 1/511 (0.2%) | ||
| Hyperventilation | 0/510 (0%) | 1/511 (0.2%) | ||
| Lung infiltration | 0/510 (0%) | 1/511 (0.2%) | ||
| Nasal congestion | 0/510 (0%) | 1/511 (0.2%) | ||
| Nasal discomfort | 1/510 (0.2%) | 0/511 (0%) | ||
| Nasal dryness | 0/510 (0%) | 1/511 (0.2%) | ||
| Nasal mucosal erosion | 1/510 (0.2%) | 0/511 (0%) | ||
| Nasal mucosal ulcer | 1/510 (0.2%) | 0/511 (0%) | ||
| Nasal obstruction | 1/510 (0.2%) | 0/511 (0%) | ||
| Nasal septum ulceration | 1/510 (0.2%) | 0/511 (0%) | ||
| Nasal ulcer | 0/510 (0%) | 2/511 (0.4%) | ||
| Oropharyngeal discomfort | 0/510 (0%) | 1/511 (0.2%) | ||
| Oropharyngeal pain | 3/510 (0.6%) | 3/511 (0.6%) | ||
| Pharyngeal erythema | 1/510 (0.2%) | 0/511 (0%) | ||
| Pharyngeal ulceration | 1/510 (0.2%) | 0/511 (0%) | ||
| Pleural rub | 0/510 (0%) | 1/511 (0.2%) | ||
| Pleuritic pain | 0/510 (0%) | 1/511 (0.2%) | ||
| Rales | 0/510 (0%) | 1/511 (0.2%) | ||
| Rhinalgia | 1/510 (0.2%) | 0/511 (0%) | ||
| Rhinitis allergic | 3/510 (0.6%) | 1/511 (0.2%) | ||
| Rhinitis perennial | 1/510 (0.2%) | 0/511 (0%) | ||
| Rhinorrhoea | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Sneezing | 2/510 (0.4%) | 3/511 (0.6%) | ||
| Throat irritation | 0/510 (0%) | 1/511 (0.2%) | ||
| Upper-airway cough syndrome | 2/510 (0.4%) | 0/511 (0%) | ||
| Wheezing | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Yawning | 0/510 (0%) | 1/511 (0.2%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Actinic keratosis | 8/510 (1.6%) | 8/511 (1.6%) | ||
| Alopecia | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Blister | 0/510 (0%) | 3/511 (0.6%) | ||
| Dermatitis | 5/510 (1%) | 2/511 (0.4%) | ||
| Dermatitis allergic | 1/510 (0.2%) | 0/511 (0%) | ||
| Dermatitis contact | 2/510 (0.4%) | 2/511 (0.4%) | ||
| Drug eruption | 0/510 (0%) | 1/511 (0.2%) | ||
| Dry skin | 3/510 (0.6%) | 2/511 (0.4%) | ||
| Ecchymosis | 0/510 (0%) | 1/511 (0.2%) | ||
| Eczema | 5/510 (1%) | 6/511 (1.2%) | ||
| Eczema nummular | 0/510 (0%) | 1/511 (0.2%) | ||
| Erythema | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Hand dermatitis | 0/510 (0%) | 1/511 (0.2%) | ||
| Hyperhidrosis | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Hyperkeratosis | 2/510 (0.4%) | 0/511 (0%) | ||
| Ingrowing nail | 0/510 (0%) | 1/511 (0.2%) | ||
| Lichen planus | 0/510 (0%) | 1/511 (0.2%) | ||
| Lichen sclerosus | 0/510 (0%) | 1/511 (0.2%) | ||
| Miliaria | 0/510 (0%) | 2/511 (0.4%) | ||
| Nail discolouration | 0/510 (0%) | 1/511 (0.2%) | ||
| Onychomalacia | 0/510 (0%) | 1/511 (0.2%) | ||
| Papule | 0/510 (0%) | 2/511 (0.4%) | ||
| Pemphigus | 0/510 (0%) | 1/511 (0.2%) | ||
| Photosensitivity reaction | 1/510 (0.2%) | 0/511 (0%) | ||
| Pigmentation disorder | 1/510 (0.2%) | 0/511 (0%) | ||
| Pruritus | 3/510 (0.6%) | 6/511 (1.2%) | ||
| Psoriasis | 1/510 (0.2%) | 0/511 (0%) | ||
| Purpura | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Rash | 8/510 (1.6%) | 13/511 (2.5%) | ||
| Rash erythematous | 0/510 (0%) | 3/511 (0.6%) | ||
| Rash papular | 1/510 (0.2%) | 0/511 (0%) | ||
| Rash pruritic | 2/510 (0.4%) | 0/511 (0%) | ||
| Rosacea | 1/510 (0.2%) | 0/511 (0%) | ||
| Skin exfoliation | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Skin fissures | 1/510 (0.2%) | 0/511 (0%) | ||
| Skin irritation | 1/510 (0.2%) | 0/511 (0%) | ||
| Skin lesion | 8/510 (1.6%) | 5/511 (1%) | ||
| Skin ulcer | 1/510 (0.2%) | 3/511 (0.6%) | ||
| Urticaria | 2/510 (0.4%) | 0/511 (0%) | ||
| Surgical and medical procedures | ||||
| Cancer surgery | 1/510 (0.2%) | 0/511 (0%) | ||
| Cataract operation | 1/510 (0.2%) | 2/511 (0.4%) | ||
| Coronary arterial stent insertion | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Eyelid operation | 1/510 (0.2%) | 0/511 (0%) | ||
| Gastric polypectomy | 1/510 (0.2%) | 0/511 (0%) | ||
| Hernia repair | 0/510 (0%) | 1/511 (0.2%) | ||
| Joint irrigation | 0/510 (0%) | 1/511 (0.2%) | ||
| Knee arthroplasty | 0/510 (0%) | 1/511 (0.2%) | ||
| Lipoma excision | 1/510 (0.2%) | 0/511 (0%) | ||
| Prostatectomy | 0/510 (0%) | 1/511 (0.2%) | ||
| Ptosis repair | 0/510 (0%) | 1/511 (0.2%) | ||
| Skin lesion removal | 2/510 (0.4%) | 0/511 (0%) | ||
| Skin neoplasm excision | 0/510 (0%) | 2/511 (0.4%) | ||
| Spinal decompression | 0/510 (0%) | 1/511 (0.2%) | ||
| Tooth extraction | 2/510 (0.4%) | 1/511 (0.2%) | ||
| Urethral dilation procedure | 1/510 (0.2%) | 0/511 (0%) | ||
| Vitrectomy | 0/510 (0%) | 1/511 (0.2%) | ||
| Vascular disorders | ||||
| Flushing | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Haematoma | 3/510 (0.6%) | 5/511 (1%) | ||
| Hot flush | 1/510 (0.2%) | 3/511 (0.6%) | ||
| Hypertension | 9/510 (1.8%) | 19/511 (3.7%) | ||
| Hypotension | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Orthostatic hypotension | 1/510 (0.2%) | 1/511 (0.2%) | ||
| Phlebitis | 0/510 (0%) | 1/511 (0.2%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Nick Harvey |
|---|---|
| Organization | Adicet Bio |
| Phone | 857-315-5528 |
| nharvey@adicetbio.com |
Responsible Party:
Restorbio Inc.
ClinicalTrials.gov Identifier:
NCT04668352
Other Study ID Numbers:
- RTB-101-204
First Posted:
Dec 16, 2020
Last Update Posted:
Jun 23, 2021
Last Verified:
May 1, 2021