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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004488-30 | EudraCT Number | ||
| U1111-1257-2567 | Registry Identifier | WHO Universal Trial Number |
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| Name | Class |
|---|---|
| Micron Research Ltd | UNKNOWN |
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A Phase 1b study to investigate the efficacy of PP353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.
A 2-part study. In the first part the safety, tolerability and pharmacokinetics will be assessed in up to 6 participants. In the second part, the safety, tolerability and efficacy of PP353 will be assessed in up to 40 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PP353 | Experimental |
| |
| Sham injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PP353 | Drug | active administered by intradiscal injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | All causality Treatment Emergent Adverse Events. Any event that was not present prior to the initiation of the treatment, or any event that was already present but increased in intensity or frequency following treatment, was recorded as a treatment-emergent adverse event | 0 to 12 months |
| Change From Baseline in Low Back Pain Numerical Rating Scale (LBP NRS) Score | Each question will be assessed by the subject on an 11-point scale with 0 = "no pain" and 10 = "the worst possible pain you can imagine." A lower score indicates less pain. The Low Back Pain Numerical Rating score throughout this protocol is defined as the average of the score of the three questions:
Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Roland Morris Disability Questionnaire-23 Score | The Roland Morris Disability Questionnaire (RMDQ)-23 is a self-administered disability measure consisting of 23 questions. Participants are asked to read a list of 23 sentences and answer "yes" or "no" to each question depending on how the participant feels each sentence describes them today. . The total number of "yes" responses gives a score from 0 to 23. A lower score indicates less disability. Participants required a score of at least 9 to enter the study Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Average Low Back Pain (LBP) Intensity Numerical Rating Scale (NRS) Daily Score Over a 7-day Period | Mean Low Back Pain intensity scored on a 0-10 Numerical Rating Scale daily for 7 days prior to a time point visit. Each daily score was recorded on an 11-point NRS scale where 0 = "no pain" and "10 = the worst pain you can imagine". A lower score indicates less pain. Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A. |
Inclusion Criteria:
Exclusion Criteria:
Any vertebra with Modic 2 only lesions which:
The target lumbar disc has lost more than half its original anticipated height at the centre or it is < 5mm in height over the central 15 mm portion
A clear alternative cause for back pain
Gross facet joint degeneration or cases where the investigator believes the primary pain generator to be the facet joints
Interventional back procedure in the 6 months prior to screening or major surgery in the 12 weeks prior to screening
History of alcohol abuse or drugs of abuse in the past 2 years
Any other significant illness
Previously been treated with antimicrobial agents for their low back pain or previously received any antimicrobial intradiscal injection.
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Duncan McHale, MBBS MRCP | Weatherden Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gildhøj Privathospital København | Copenhagen | 2605 Brøndby | Denmark | |||
| CGM Research Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39544354 | Result | Tripathi SS, Sneath R, Golash A, Desai P, McHale D, Guest S, Brindley C, Cummings P, Smith S, Stroud C, Scott G, Ruston S, Czaplewski L. Pharmacokinetics of PP353, a formulation of linezolid for intervertebral disc administration, in patients with chronic low back pain and Modic change Type 1: A first-in-human, Phase 1b, open-label, single-dose study. JOR Spine. 2024 Nov 14;7(4):e70009. doi: 10.1002/jsp2.70009. eCollection 2024 Dec. | |
| 41768986 |
| Label | URL |
|---|---|
| Intradiscal linezolid (PP353) treatment for chronic low back pain associated with Modic change type 1: an international, first-in-human, randomised, sham procedure-controlled, double-blind, phase 1b clinical trial | View source |
Not provided
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In Part A, 9 participants were screened, 3 of whom were included in the study. No summary analyses were conducted for efficacy in Part A.
In Part B, 136 participants were screened, 40 of whom were randomised and met the criteria to be included in the Full Analysis Set (FAS).
3 participants were recruited into Part A and 40 in Part B. Participants were recruited through community and hospital pain clinics, referrals from other centres and social media campaigns, between Jan 2020 to Dec 2023, at 10 trial sites: 6 in the UK, 2 in Spain, 1 in New Zealand and 1 in Denmark For Part B, the Full Analysis Set consisted of all enrolled subjects who received at least one dose of PP353 or placebo and had a valid post-baseline measurement for at least one efficacy variable.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A PP353 | Open label PP353: Intradiscal linezolid (150 mg) dosed on Day 1 |
| FG001 | Part B PP353 | PP353: Intradiscal linezolid (150 mg) dosed on Day 1 and Day 5 (+/- 1 Day) Double-blind, randomised |
| FG002 | Part B Placebo | Placebo: Sham injection on Day 1 and Day 5 (+/- 1 Day) Double-blind, randomised |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A PP353 | Open label PP353: Intradiscal linezolid (150 mg) dosed on Day 1 |
| BG001 | PP353 | PP353: Intradiscal linezolid (150 mg) dosed on Day 1 and Day 5 (+/- 1 Day) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events | All causality Treatment Emergent Adverse Events. Any event that was not present prior to the initiation of the treatment, or any event that was already present but increased in intensity or frequency following treatment, was recorded as a treatment-emergent adverse event | Full Analysis Set (FAS) consisted of all enrolled subjects who received at least one dose of PP353 or placebo and had a valid post-baseline measurement for at least one efficacy variable. | Posted | Count of Participants | Participants | 0 to 12 months |
|
From enrollment until end of follow-up, up to 12 months from randomisation
All causality Treatment Emergent Adverse Events (except Serious Adverse Events). Any event that was not present prior to the initiation of the treatment, or any event that was already present but increased in intensity or frequency following treatment, was recorded as a treatment-emergent adverse event (TEAEs)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A PP353 | Open label PP353: Intradiscal linezolid (150 mg) dosed on Day 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Encephalitis viral (NOS) | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Duncan McHale | Weatherden Ltd | +44 1227 910152 | info@persicapharmaceuticals.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2024 | Dec 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2024 | Dec 4, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Part A is open label Part B is parallel placebo controlled
Not provided
Not provided
Part A is open label In Part B the pharmacist and injector will not be blinded to treatment allocation
| Other |
Sham injection |
|
| 12 months |
| Clinically Relevant Improvement (≥30%) in RMDQ-23 | The Roland Morris Disability Questionnaire (RMDQ)-23 is a self-administered disability measure consisting of 23 questions. Participants are asked to read a list of 23 sentences and answer "yes" or "no" to each question depending on how the participant feels each sentence describes them today. . The total number of "yes" responses gives a score from 0 to 23. A lower score indicates less disability. Participants required a score of at least 9 to enter the study Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A. | 12 months |
| Change From Baseline in Oswestry Disability Index | The ODI is a subject-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. A lower score indicates less disability. Scores are interpreted as follows: 0-20%: minimal disability 21-40%: moderate disability 41-60%: severe disability 61-80% crippled 81-100%: bed-bound Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A. | 12 months |
| 12 months |
| Christchurch |
| 8083 |
| New Zealand |
| Hospital Vithas Granada | Granada | Spain |
| Hospital Universitario LA PAZ | Madrid | Spain |
| Royal Preston Hospital | Preston | Lancashire | PR2 9HT | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | Oxford | OX3 9DU | United Kingdom |
| University Hospital Of Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| University Hospital Coventry & Warwickshire | Coventry | CV2 2DX | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| University Hospital Southampton Nhs Foundation Trust | Southampton | SO16 6YD | United Kingdom |
| Result |
| Lassen MR, Scarborough M, Gilchrist N, Tripathi SS, Price C, Horcajadas A, DeAndres J, Baranidharan G, Ahuja S, Otte KS, Wood E, Guest S, Czaplewski LG, McHale D; Modic Trial (TMT) group. Intradiscal linezolid (PP353) treatment for chronic low back pain associated with Modic change type 1: an international, first-in-human, randomised, sham procedure-controlled, double-blind, phase 1b clinical trial. EClinicalMedicine. 2026 Feb 2;92:103764. doi: 10.1016/j.eclinm.2026.103764. eCollection 2026 Feb. |
| Pharmacokinetics of PP353, a formulation of linezolid for intervertebral disc administration, in patients with chronic low back pain and Modic change Type 1: A first-in-human, Phase 1b, open-label, single-dose study | View source |
| BG002 | Placebo | Placebo: Sham injection on Day 1 and Day 5 (+/- 1 Day) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Roland Morris Disability Questionnaire-23 Score (RMDQ-23) | The RMDQ-23 is a self-administered disability measure consisting of 23 questions. | Mean | Standard Deviation | Score (0-23) |
|
| Low Back Pain Numerical Rating Scale (LBP NRS) Score | Each question will be assessed by the subject on an 11-point scale with 0 = "no pain" and 10 = "the worst possible pain you can imagine." The LBP NRS score is defined as the average of the score of the three questions: Low back pain intensity now Worst low back pain intensity in the last 14 days Average low back pain intensity over the last 14 days | Mean | Standard Deviation | Score (0-10) |
|
PP353: Intradiscal linezolid (150 mg) dosed on Day 1 and Day 5 (+/- 1 Day)
| OG002 | Placebo | Placebo: Sham injection on on Day 1 and Day 5 (+/- 1 Day) |
|
|
| Primary | Change From Baseline in Low Back Pain Numerical Rating Scale (LBP NRS) Score | Each question will be assessed by the subject on an 11-point scale with 0 = "no pain" and 10 = "the worst possible pain you can imagine." A lower score indicates less pain. The Low Back Pain Numerical Rating score throughout this protocol is defined as the average of the score of the three questions:
Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A. | The Full Analysis Set (FAS) consisted of all enrolled participants who received at least one dose of PP353 or one sham procedure and had a post-baseline measurement for at least one efficacy variable. The primary efficacy analysis used a one-sided test at the 5% significance level. Change from baseline was assessed using a mixed model repeated measures model (MMRM). | Posted | Least Squares Mean | Standard Error | Units on a scale | 12 months |
|
|
|
|
| Secondary | Change From Baseline in Roland Morris Disability Questionnaire-23 Score | The Roland Morris Disability Questionnaire (RMDQ)-23 is a self-administered disability measure consisting of 23 questions. Participants are asked to read a list of 23 sentences and answer "yes" or "no" to each question depending on how the participant feels each sentence describes them today. . The total number of "yes" responses gives a score from 0 to 23. A lower score indicates less disability. Participants required a score of at least 9 to enter the study Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A. | The Full Analysis Set (FAS) consisted of all enrolled participants who received at least one dose of PP353 or one sham procedure and had a post-baseline measurement for at least one efficacy variable. The secondary efficacy analysis used a two-sided test at the 5% significance level. Change from baseline was assessed using a mixed model repeated measures model (MMRM). | Posted | Least Squares Mean | Standard Error | Units on a scale (0-23) | 12 months |
|
|
|
|
| Secondary | Clinically Relevant Improvement (≥30%) in RMDQ-23 | The Roland Morris Disability Questionnaire (RMDQ)-23 is a self-administered disability measure consisting of 23 questions. Participants are asked to read a list of 23 sentences and answer "yes" or "no" to each question depending on how the participant feels each sentence describes them today. . The total number of "yes" responses gives a score from 0 to 23. A lower score indicates less disability. Participants required a score of at least 9 to enter the study Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A. | The Full Analysis Set (FAS) consisted of all enrolled participants who receieved at least one dose of PP353 or one sham procedure and had a post-baseline measurement for at least one efficacy variable. The secondary efficacy analysis used a two-sided test at the 5% significance level. For the purposes of the logistic regression analysis, where subjects have missed a visit(s), Last Observation Carried Forward was used to impute a result. | Posted | Number | % with ≥30% change from baseline | 12 months |
|
|
|
|
| Secondary | Change From Baseline in Oswestry Disability Index | The ODI is a subject-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. A lower score indicates less disability. Scores are interpreted as follows: 0-20%: minimal disability 21-40%: moderate disability 41-60%: severe disability 61-80% crippled 81-100%: bed-bound Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A. | The Full Analysis Set (FAS) consisted of all enrolled participants who receieved at least one dose of PP353 or one sham procedure and had a post-baseline measurement for at least one efficacy variable. The secondary efficacy analysis used a two-sided test at the 5% significance level. Estimates produced from MMRM analysis, included all scheduled post baseline visits up to Month 12. | Posted | Least Squares Mean | Standard Error | Percentage | 12 months |
|
|
|
|
| Other Pre-specified | Change From Baseline of Average Low Back Pain (LBP) Intensity Numerical Rating Scale (NRS) Daily Score Over a 7-day Period | Mean Low Back Pain intensity scored on a 0-10 Numerical Rating Scale daily for 7 days prior to a time point visit. Each daily score was recorded on an 11-point NRS scale where 0 = "no pain" and "10 = the worst pain you can imagine". A lower score indicates less pain. Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A. | The Full Analysis Set (FAS) consisted of all enrolled participants who received at least one dose of PP353 or one sham procedure and had a post-baseline measurement for at least one efficacy variable. The exploratory efficacy analysis used a two-sided test at the 5% significance level. The estimates came from a MMRM with the MMRM including all scheduled post-baseline visits up to Month 12. | Posted | Least Squares Mean | Standard Error | Score (0-10) | 12 months |
|
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | PP353 | PP353: Intradiscal linezolid (150 mg) dosed on Day 1 and Day 5 (+/- 1 Day) | 0 | 20 | 0 | 20 | 15 | 20 |
| EG002 | Placebo | Sham intradiscal injection on Day 1 and Day 5 (+/- 1 Day) | 0 | 20 | 1 | 20 | 18 | 20 |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Sacroilitis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Procedural pain | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Sensory loss | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Paresis | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
|
| Cerebrospinal fluid leakage | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
|
| Angular chelitis | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Paronychia | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Otolithiasis | Ear and labyrinth disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Ovarian cyst ruptured | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Endodontic procedure | Surgical and medical procedures | MedDRA version 26.1 | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|