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This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm infants after the neonatal period), using a population PK approach.
Primary objective is to evaluate the PK profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).
Three age groups are defined:
At study set-up, the inclusions started with the oldest patients in group 1 and using an age-down staggered approach.
The decision to start the inclusions in group 2 was taken by the Trial Safety Review Board based on safety assessment over one-day period after injection of the first 13 patients in group 1.
According to the protocol version 4 (amendments 2 & 3), the age-down staggered approach was discontinued to allow the inclusions in Group 3 (patients aged from birth to 27 days), simultaneously to inclusions in group 1 and group 2.
A total of 3 blood samples per patient were taken post-injection for PK analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age Group 1: patients aged 3 to 23 months | Experimental | One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. |
|
| Age Group 2: patients aged 28 days to less than 3 months | Experimental | One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. |
|
| Age Group 3: patients aged from birth to 27 days (term newborns) | Experimental | One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadopiclenol | Drug | Patients will receive a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol will be administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW). |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUCinf) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours) |
| Elimination Half-life (t1/2α) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
| Terminal Half-life (t1/2β) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
| Gadopiclenol Concentrations 10 Min Post-injection (C10 Min) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | blood sample collection 10 minutes post-injection of gadopiclenol for analysis |
| Gadopiclenol Concentration 20 Min Post-injection (C20 Min) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | blood sample collection 20 minutes post-injection of gadopiclenol |
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Main Inclusion Criteria:
Main Exclusion Criteria:
9. Patient undergoing a change in chemotherapy (product or dosage) within one day prior to or one day after gadopiclenol administration, 10. Patient who received or will receive any other contrast agent for CT and/or MRI within one week prior to or one week after gadopiclenol administration, 11. Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker), 12. Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents [...]
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| Name | Affiliation | Role |
|---|---|---|
| Donna R Roberts, MD | Medical University of South Carolina, Division of Neuroradiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnatti Childrens Hospital | Cincinnati | Ohio | 45229 | United States | ||
| Medical University of South Carolina |
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| ID | Title | Description |
|---|---|---|
| FG000 | Age Group 1: Patients Aged 3 to 23 Months | One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW). |
| FG001 | Age Group 2: Patients Aged 28 Days to Less Than 3 Months | One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW). |
| FG002 | Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) | One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population included 36 patients who received one injection of gadopiclenol (safety set): 33 patients aged 3 to 23 months, 2 aged 28 days to less than 3 months and 1 patient aged 0-27 days.
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| ID | Title | Description |
|---|---|---|
| BG000 | Age Group 1: Patients Aged 3 to 23 Months | One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW). |
| 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 | Area Under the Curve (AUCinf) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | h.mg/L | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours) |
|
Adverse events (AE) occurring from the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (up to 3 months following gadopiclenol administration).
Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
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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 | Age Group 1: Patients Aged 3 to 23 Months | Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeding Disorder | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment | Feeding Difficulties |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment | Upper Respiratory Viral Infection |
Due to incomplete recruitment in study GDX-44-015, with only 2 patients aged 28-89 days and none aged less than 28 days who could be included in the popPK analysis, exposure in these groups was only obtained by simulation using the final model.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frantz Hebert, Global Head of Clinical Development | Guerbet | +33 680249334 | frantz.hebert@guerbet.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 | Oct 9, 2023 | Jul 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 29, 2024 | Jul 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000656634 | gadopiclenol |
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|
| Gadopiclenol Concentrations 30 Min Post-injection (C30 Min) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | blood sample collection 30 minutes post-injection of gadopiclenol |
| Clearance | Individual predicted final model parameter scaled by body weight | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
| Central Volume of Distribution (V1) | Individual predicted final model parameter scaled by body weight | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
| Inter-compartment Clearance (Q) | Individual predicted final model parameter scaled by body weight | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
| Peripheral Volume of Distribution (V2) | Individual predicted final model parameter scaled by body weight | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
| Charleston |
| South Carolina |
| 29425-8908 |
| United States |
| Semmelweis Egyetem | Budapest | 1094 | Hungary |
| Országos Idegtudományi Intézet | Budapest | Hungary |
| University of Debrecen Clinical Center Pediatric Department | Debrecen | Hungary |
| Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza | Bydgoszcz | Poland |
| Instytut Centrum Zdrowia Matki Polki | Lodz | Poland |
| Uniwersytecki Szpital Dzieciecy | Lublin | Poland |
| Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej | Rzeszów | Poland |
| Uniwersyteckie Centrum Kliniczne Warszawskiego | Warsaw | 02-091 | Poland |
| Instytut "Pomnik - Centrum Zdrowia Dziecka" | Warsaw | Poland |
| BG001 |
| Age Group 2: Patients Aged 28 Days to Less Than 3 Months |
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW). |
| BG002 | Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) | One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW). |
| BG003 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilogram |
|
| OG001 | Age Group 2: Patients Aged 28 Days to Less Than 3 Months | Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight). |
| OG002 | Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) | Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight). |
|
|
| Primary | Elimination Half-life (t1/2α) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
|
|
|
| Primary | Terminal Half-life (t1/2β) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
|
|
|
| Primary | Gadopiclenol Concentrations 10 Min Post-injection (C10 Min) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/L | blood sample collection 10 minutes post-injection of gadopiclenol for analysis |
|
|
|
| Primary | Gadopiclenol Concentration 20 Min Post-injection (C20 Min) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/L | blood sample collection 20 minutes post-injection of gadopiclenol |
|
|
|
| Primary | Gadopiclenol Concentrations 30 Min Post-injection (C30 Min) | Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg | Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/L | blood sample collection 30 minutes post-injection of gadopiclenol |
|
|
|
| Primary | Clearance | Individual predicted final model parameter scaled by body weight | Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days. | Posted | Mean | Standard Deviation | L/h/kg | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
|
|
|
| Primary | Central Volume of Distribution (V1) | Individual predicted final model parameter scaled by body weight | Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days. | Posted | Mean | Standard Deviation | L/kg | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
|
|
|
| Primary | Inter-compartment Clearance (Q) | Individual predicted final model parameter scaled by body weight | Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days | Posted | Mean | Standard Deviation | L/h/kg | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
|
|
|
| Primary | Peripheral Volume of Distribution (V2) | Individual predicted final model parameter scaled by body weight | Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days. | Posted | Mean | Standard Deviation | L/kg | A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). |
|
|
|
| 0 |
| 33 |
| 8 |
| 33 |
| 13 |
| 33 |
| EG001 | Age Group 2: Patients Aged 28 Days to Less Than 3 Months | Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight). | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) | Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight). | 0 | 1 | 0 | 1 | 0 | 1 |
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| Tumour Excision | Surgical and medical procedures | MedDRA v27.0 | Systematic Assessment | Tumour Resection For Suprasellar Optic Glioma |
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| Pyrexia | General disorders | MedDRA v27.0 | Systematic Assessment | Central Fever |
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| Microcytic Anaemia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment | Microcytic Anemia |
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| Gastroenteritis Norovirus | Infections and infestations | MedDRA v27.0 | Systematic Assessment | Gastroenteritis - Norovirus |
|
| Pneumonia Parainfluenzae Viral | Infections and infestations | MedDRA v27.0 | Systematic Assessment | Hospitalization On Intensive Care Unit - Respiratory Failure, Pneumonia - Hpiv-3 Virus |
|
| Bronchitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment | Severe Upper Respiratory Tract Infection With Severe Bronchitis |
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| Cerebral Cyst | Nervous system disorders | MedDRA v27.0 | Systematic Assessment | Cerebral Sella Turcic Cyst Growth |
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| Intracranial Pressure Increased | Nervous system disorders | MedDRA v27.0 | Systematic Assessment | Intercranial Hypertension |
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| Device Malfunction | Product Issues | MedDRA v27.0 | Systematic Assessment | Disfunction Of Ventriculoperitoneal Shunt System |
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| Renal Failure | Renal and urinary disorders | MedDRA v27.0 | Systematic Assessment | Worsening Of Pre-Existing Renal Failure |
|
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| Conjunctivitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA v27.0 | Systematic Assessment | Paronychia On The Toes |
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| Hand-Foot-And-Mouth Disease | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment | Anxiety |
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| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment | Choke On Saliva |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment | Light Redness Of Cheecks And Tip Of The Nose |
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| Astigmatism | Eye disorders | MedDRA v27.0 | Systematic Assessment |
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| Myopia | Eye disorders | MedDRA v27.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment | Rash On Face |
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| Nausea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment | Runny Nose |
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| White Blood Cell Count Increased | Investigations | MedDRA v27.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment | Nasal Mild Congestion |
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| Respiratory Tract Infection Viral | Infections and infestations | MedDRA v27.0 | Systematic Assessment | Respiratory Tract Viral Illness Infection |
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| Anaphylactic Reaction | Immune system disorders | MedDRA v27.0 | Systematic Assessment | Peanut Induced Anaphylaxis |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA v27.0 | Systematic Assessment |
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| Serum Ferritin Increased | Investigations | MedDRA v27.0 | Systematic Assessment |
|
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