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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000467-24 | EudraCT Number |
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This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patisiran (ALN-TTR02) | Experimental | Two administrations of patisiran will be administered once every 4 weeks [Q4W]) in 4 sequential cohorts with escalating doses followed by optional cohorts with an alternative dosing regimen (once every 3 weeks [Q3W]), and an alternative premedication regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patisiran | Drug | Participants received a single dose of patisiran as an intravenous (IV) infusion on Day 0 and Day 28 (Q4W). Optional cohorts received an alternative dosing regimen (once every 3 weeks [Q3W]: Day 0 and Day 21) and an alternative premedication regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Drug Discontinuation | The number of participants experiencing at least one adverse event (AE), at least one serious adverse event (SAE) and study drug discontinuation (due to any reason). | Up to 56 days post first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Serum Transthyretin (TTR) Protein | Percentage change of TTR relative to pretreatment/baseline levels is reported. For arms with a dosing regimen of Q4W TTR protein samples were measured on Days 28 and 56. For the arms with a dosing regimen of Q3W TTR protein samples were measured on Days 21 and 42. | Baseline to Day 21/28 and Day 42/56 depending on dosing regimen (Q3W/Q4W) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Gollob, MD | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Boston | Massachusetts | United States | |||
| Clinical Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26338094 | Derived | Suhr OB, Coelho T, Buades J, Pouget J, Conceicao I, Berk J, Schmidt H, Waddington-Cruz M, Campistol JM, Bettencourt BR, Vaishnaw A, Gollob J, Adams D. Efficacy and safety of patisiran for familial amyloidotic polyneuropathy: a phase II multi-dose study. Orphanet J Rare Dis. 2015 Sep 4;10:109. doi: 10.1186/s13023-015-0326-6. |
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Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU.
Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Requests for access to data can be submitted via the website www.vivli.org.
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A total of 29 subjects were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Patisiran 0.010 mg/kg Q4W | Participants received 0.010 mg/kg of patisiran (ALN-TTR02) every four weeks (Q4W). |
| FG001 | Patisiran 0.050 mg/kg Q4W | Participants received 0.050 mg/kg of patisiran (ALN-TTR02) every four weeks. |
| FG002 | Patisiran 0.150 mg/kg Q4W | Participants received 0.150 mg/kg of patisiran (ALN-TTR02) every four weeks. |
| FG003 | Patisiran 0.300 mg/kg Q4W | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every four weeks. |
| FG004 | Patisiran 0.300 mg/kg Q3W | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks (Q3W). |
| FG005 | Patisiran 0.300 mg/kg Q3W Alternative | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks with alternative premedication regimen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patisiran 0.010 mg/kg Q4W | Participants received 0.010 mg/kg of patisiran (ALN-TTR02) every four weeks (Q4W). |
| BG001 | Patisiran 0.050 mg/kg Q4W | Participants received 0.050 mg/kg of patisiran (ALN-TTR02) every four weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Drug Discontinuation | The number of participants experiencing at least one adverse event (AE), at least one serious adverse event (SAE) and study drug discontinuation (due to any reason). | Intent-to-treat (ITT) population included all participants, who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 56 days post first dose |
|
From first dose of study drug up to Day 56
ITT population was the primary set for safety data and included all participants, who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patisiran 0.010 mg/kg Q4W | Participants received 0.010 mg/kg of patisiran (ALN-TTR02) every four weeks (Q4W). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Alnylam Pharmaceuticals, Inc. | 1-877-256-9526 | medinfo@alnylam.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2013 | Aug 30, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2013 | Aug 30, 2018 | SAP_000.pdf |
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| ID | Term |
|---|---|
| C000606954 | patisiran |
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|
| Pharmacokinetic Parameters of Patisiran - Area Under the Concentration Curve From Time 0 to Last Measurable Time Point (AUC0-last) | Pharmacokinetic profiles for patisiran (ALN-TTR02) were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing regimen (Q3W/Q4W) |
| Pharmacokinetic Parameters of Patisiran - Maximum Observed Plasma Concentration (Cmax) | Pharmacokinetic profiles for patisiran (ALN-TTR02) were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing regimen (Q3W/Q4W) |
| Pharmacokinetic Parameters of Patisiran - Beta Elimination Half-life (t1/2 Beta) | Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing frequency |
| Pharmacokinetic Parameters of Patisiran - Systemic Clearance (CL) | Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing frequency |
| Pharmacokinetic Parameters of Patisiran - Apparent Volume of Distribution at Steady State (Vss) | Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing frequency |
| Pharmacokinetic Parameters of Patisiran - Renal Clearance (CLR) | Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | Predose (within 1 h of planned dosing start) and post-infusion at 0-6 h (pooled) on Day 0 and Day 21/28 depending on dosing frequency |
| Rio de Janeiro |
| Brazil |
| Clinical Trial Site | Le Kremlin-Bicêtre | France |
| Clinical Trial Site | Marseille | France |
| Clinical Trial Site | Münster | Germany |
| Clinical Trial Site | Lisbon | Portugal |
| Clinical Trial Site | Porto | Portugal |
| Clinical Trial Site | Barcelona | Spain |
| Clinical Trial Site | Palma de Mallorca | Spain |
| Clinical Trial Site | Umeå | Sweden |
| Withdrawal by Subject |
|
| Dosing Suspended by Sponsor |
|
| BG002 | Patisiran 0.150 mg/kg Q4W | Participants received 0.150 mg/kg of patisiran (ALN-TTR02) every four weeks. |
| BG003 | Patisiran 0.300 mg/kg Q4W | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every four weeks. |
| BG004 | Patisiran 0.300 mg/kg Q3W | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks (Q3W). |
| BG005 | Patisiran 0.300 mg/kg Q3W Alternative | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks with alternative premedication regimen. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Patisiran 0.150 mg/kg Q4W | Participants received 0.150 mg/kg of patisiran (ALN-TTR02) every four weeks. |
| OG003 | Patisiran 0.300 mg/kg Q4W | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every four weeks. |
| OG004 | Patisiran 0.300 mg/kg Q3W | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks (Q3W). |
| OG005 | Patisiran 0.300 mg/kg Q3W Alternative | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks with alternative premedication regimen. |
|
|
| Secondary | Percentage Change From Baseline in Serum Transthyretin (TTR) Protein | Percentage change of TTR relative to pretreatment/baseline levels is reported. For arms with a dosing regimen of Q4W TTR protein samples were measured on Days 28 and 56. For the arms with a dosing regimen of Q3W TTR protein samples were measured on Days 21 and 42. | ITT population included all participants, who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Percentage | Baseline to Day 21/28 and Day 42/56 depending on dosing regimen (Q3W/Q4W) |
|
|
|
| Secondary | Pharmacokinetic Parameters of Patisiran - Area Under the Concentration Curve From Time 0 to Last Measurable Time Point (AUC0-last) | Pharmacokinetic profiles for patisiran (ALN-TTR02) were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen. | Posted | Mean | Standard Deviation | ng*h/mL | Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing regimen (Q3W/Q4W) |
|
|
|
| Secondary | Pharmacokinetic Parameters of Patisiran - Maximum Observed Plasma Concentration (Cmax) | Pharmacokinetic profiles for patisiran (ALN-TTR02) were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen. | Posted | Mean | Standard Deviation | ng/mL | Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing regimen (Q3W/Q4W) |
|
|
|
| Secondary | Pharmacokinetic Parameters of Patisiran - Beta Elimination Half-life (t1/2 Beta) | Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen. | Posted | Mean | Standard Deviation | hour (h) | Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing frequency |
|
|
|
| Secondary | Pharmacokinetic Parameters of Patisiran - Systemic Clearance (CL) | Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen. | Posted | Mean | Standard Deviation | L/h/kg | Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing frequency |
|
|
|
| Secondary | Pharmacokinetic Parameters of Patisiran - Apparent Volume of Distribution at Steady State (Vss) | Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen. | Posted | Mean | Standard Deviation | L/kg | Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing frequency |
|
|
|
| Secondary | Pharmacokinetic Parameters of Patisiran - Renal Clearance (CLR) | Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21. | The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen. | Posted | Mean | Standard Deviation | mL/h/kg | Predose (within 1 h of planned dosing start) and post-infusion at 0-6 h (pooled) on Day 0 and Day 21/28 depending on dosing frequency |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Patisiran 0.050 mg/kg Q4W | Participants received 0.050 mg/kg of patisiran (ALN-TTR02) every four weeks. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Patisiran 0.150 mg/kg Q4W | Participants received 0.150 mg/kg of patisiran (ALN-TTR02) every four weeks. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | Patisiran 0.300 mg/kg Q4W | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every four weeks. | 0 | 7 | 1 | 7 | 7 | 7 |
| EG004 | Patisiran 0.300 mg/kg Q3W | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks (Q3W). | 0 | 3 | 0 | 3 | 3 | 3 |
| EG005 | Patisiran 0.300 mg/kg Q3W Alternative | Participants received 0.300 mg/kg of patisiran (ALN-TTR02) every three weeks with alternative premedication regimen. | 0 | 9 | 1 | 9 | 7 | 9 |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Extravasation | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Infusion related reaction | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
Not provided
|
| Day 42 or 56 |
|
|
|
| Day 21 or Day 28 |
|
|
|
| Day 21 or 28 |
|
|
|
| Day 21 or 28 |
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|
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| Day 21 or 28 |
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|
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| Day 21 or 28 |
|
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| Day 21 or 28 |
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