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Business decision, not related to safety.
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A Phase 1/2, open-label, multicenter study to determine dose, tolerability, safety and efficacy of poziotinib in Japanese patients non-small cell lung cancer (NSCLC).
This is a Phase 1/2, open-label, multicenter study in Japanese patients with locally advanced or metastatic NSCLC. This study will be conducted in two parts. Phase 1 is designed to observe the maximum tolerated dose (MTD) or maximum administered dose (MAD) of poziotinib when administered once daily or twice daily. Phase 2 will evaluate the safety and efficacy of the dose determined in Phase 1. Study participation includes a 30 day screening period, up to 24 months of treatment, and long-term follow-up for a maximum of 24 months after discontinuation of study treatment.
Phase 1 will enroll up to 36 patients into a dose finding study with two parallel, randomized dose groups. Each group will undergo a dose-finding scheme using a 3+3 design with the assessment of dose-limiting toxicities (DLTs) at up to three dose levels. Patients will be randomized into once daily (QD) or twice daily (BID) dose groups. The DLT assessment will be conducted in the first cycle of treatment and therefore, poziotinib dose modifications are not permitted during this cycle. Patients will be hospitalized for the first 2 weeks.
Phase 2 will enroll 40 additional NSCLC patients with epidermal growth factor receptor (EGFR) (20 patients) or human epidermal growth factor 2 (HER2) (20 patients) exon 20 insertion mutations. Efficacy and safety of the dose and dosing regimen determined in Phase 1 will be evaluated. All patients will be treated in 28-day cycles for up to 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Once Daily Dosing | Experimental | Dose finding at 8 mg, 12 mg, or 16 mg of poziotinib once daily in 28-day treatment cycles. |
|
| Phase 1: Twice Daily Dosing | Experimental | Dose finding at 4 mg, 6 mg, or 8 mg of poziotinib twice daily in 28-day treatment cycles. |
|
| Phase 2: Once Daily Dosing or Twice Daily Dosing | Experimental | Once Daily or Twice Daily Dosing as determined in Phase 1 in 28-day treatment cycles. Cohort 1: EGFR exon 20 insertion mutations Cohort 2: HER2 exon 20 insertion mutations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poziotinib Once Daily Dosing | Drug | The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was any of the following treatment-related adverse events occurring during Cycle 1, Non-Hematological Toxicity: Grade 3 or higher toxicity except for alopecia; Grade 3 or higher nausea, vomiting, and diarrhea despite medical intervention. Hematological Toxicity: Grade 4 or higher neutropenia for ≥7 days; Febrile neutropenia with a single temperature of >38.3°C or a sustained temperature of ≥38°C; Neutropenic infection: Grade 3 or higher infection accompanying Grade 4 neutropenia; Grade 4 thrombocytopenia or any grade thrombocytopenia requiring platelet transfusion. | Cycle 1 (Day 1-28) |
| Phase 2: Objective Response Rate (ORR) | ORR was defined as the percentage of participants with best response i.e confirmed complete response (CR) and partial response (PR) as assessed by the investigator using local radiology evaluation according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. | Up to 461 days |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Disease Control Rate (DCR) | The percentage of participants who achieve CR, PR, and stable disease (SD) by the best response from the first dose of poziotinib to the end of the study as assessed by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Exploratory - Overall Survival | The number of days from the treatment start date to the date of death due to any cause. | 2 years |
Key Inclusion Criteria:
Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements
Previously treated patient with histologically or cytologically confirmed (archival tissue accepted) locally advanced or metastatic non-small cell lung cancer (NSCLC) and is not a candidate for definitive therapy
Prior treatment status:
Patient has measurable NSCLC disease, as per the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). Metastatic lesions in bone, central nervous system (CNS), or in brain cannot be used for target lesions.
Patient has recovered from prior systemic therapy for metastatic disease to Grade ≤1 for non-hematologic toxicities (except for Grade ≤2 peripheral neuropathy) and has adequate hematologic, hepatic, and renal function at Baseline
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center East | Kashiwa | Chiba | 277-8577 | Japan | ||
| Osaka City General Hospital |
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Participants took part in Phase 1 (Dose Escalation) and Phase 2 (Efficacy) of the study. Phase 2 was terminated early.
A total of 42 participants were enrolled at multiple investigative sites in Japan from 23 Jun 2020 to 15 Feb 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Poziotinib 8 mg QD | Participants received poziotinib 8 milligrams (mg) orally, once daily (QD) in each 28-day treatment cycle. |
| FG001 | Phase 1: Poziotinib 12 mg QD | Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle. |
| FG002 | Phase 1: Poziotinib 16 mg QD | Participants received poziotinib 16 mg orally, QD in each 28-day treatment cycle. |
| FG003 | Phase 1: Poziotinib 4 mg BID | Participants received poziotinib 4 mg orally, twice daily (BID) in each 28-day treatment cycle. |
| FG004 | Phase 1: Poziotinib 6 mg BID | Participants received poziotinib 6 mg orally, BID in each 28-day treatment cycle. |
| FG005 | Phase 1: Poziotinib 8 mg BID | Participants received poziotinib 8 mg orally, BID in each 28-day treatment cycle. |
| FG006 | Phase 2: Poziotinib 12 mg QD | Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who signed informed consent, enrolled and received at least 1 dose of poziotinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Poziotinib 8 mg QD | Participants received poziotinib 8 mg orally, QD in each 28-day treatment cycle. |
| BG001 | Phase 1: Poziotinib 12 mg QD | Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle. |
| 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 | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was any of the following treatment-related adverse events occurring during Cycle 1, Non-Hematological Toxicity: Grade 3 or higher toxicity except for alopecia; Grade 3 or higher nausea, vomiting, and diarrhea despite medical intervention. Hematological Toxicity: Grade 4 or higher neutropenia for ≥7 days; Febrile neutropenia with a single temperature of >38.3°C or a sustained temperature of ≥38°C; Neutropenic infection: Grade 3 or higher infection accompanying Grade 4 neutropenia; Grade 4 thrombocytopenia or any grade thrombocytopenia requiring platelet transfusion. | Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib. | Posted | Count of Participants | Participants | Cycle 1 (Day 1-28) |
|
Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
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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 | Phase 1: Poziotinib 8 mg QD | Participants received poziotinib 8 mg orally, QD, in each 28-day treatment cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amylase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
The study was prematurely terminated for business reasons and not related to safety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Franklin, MD | Assertio Holdings | 224 419 7106 | Hfranklin@assertiotx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2020 | Apr 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017321 | Clinical Trials, Phase I as Topic |
| ID | Term |
|---|---|
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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Phase 1 will have two randomized, parallel dose groups comparing daily dosing and twice daily dosing at 3 dose levels.
Phase 2 will be a single dose group evaluating the safety and efficacy of the dose determined in Phase 1 in 2 Cohorts. Cohort 1: EGFR exon 20 insertion mutations and Cohort 2: HER2 exon 20 insertion mutations.
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| Poziotinib Twice Daily Dosing | Drug | The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration. |
|
| Poziotinib Once Daily Dosing or Twice Daily Dosing as determined in Phase 1 | Drug | The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration. |
|
| Up to 461 days |
| Phase 2: Duration of Response (DoR) | Duration of response was defined as the time from the date that measurement criteria are first met for CR or PR until the first subsequent date that progressive disease as assessed by the investigator according to RECIST v1.1 or death is documented. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. | Up to 461 days |
| Phase 2: Progression Free Survival (PFS) | PFS was the number of days from the treatment start date to the date of first documented disease progression or death from any cause. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in sum of diameters (SOD) from previous smallest SOD on study, and an absolute increase of ≥5mm. | Up to 461 days |
| Phase 1: Plasma Concentration of Poziotinib and M1, M2 Metabolites | Cycle 1, Day 1 and Day 13 |
| Phase 1 and 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs are AEs that occur from the first dose of study treatment until 40 days after the last dose of study treatment. An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. | Up to 40 days after the last dose of the study drug (Up to 461 days) |
| Miyakojima-ku |
| Osaka |
| 534-0021 |
| Japan |
| Shizuoka Cancer Center | Sunto District | Shizuoka | 411-8777 | Japan |
| Disease Progression |
|
| Withdrawal by Subject |
|
| Sponsor Decision |
|
| Death |
|
| Other |
|
| BG002 | Phase 1: Poziotinib 16 mg QD | Participants received poziotinib 16 mg orally, QD in each 28-day treatment cycle. |
| BG003 | Phase 1:Poziotinib 4 mg BID | Participants received poziotinib 4 mg orally, BID in each 28-day treatment cycle. |
| BG004 | Phase 1: Poziotinib 6 mg BID | Participants received poziotinib 6 mg orally, BID in each 28-day treatment cycle. |
| BG005 | Phase 1: Poziotinib 8 mg BID | Participants received poziotinib 8 mg orally, BID in each 28-day treatment cycle. |
| BG006 | Phase 2: Poziotinib 12 mg QD | Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Phase 1: Poziotinib 12 mg QD | Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle. |
| OG002 | Phase 1: Poziotinib 16 mg QD | Participants received poziotinib 16 mg orally, QD in each 28-day treatment cycle. |
| OG003 | Phase 1: Poziotinib 4 mg BID | Participants received poziotinib 4 mg orally, BID in each 28-day treatment cycle. |
| OG004 | Phase 1: Poziotinib 6 mg BID | Participants received poziotinib 6 mg orally, BID in each 28-day treatment cycle. |
| OG005 | Phase 1: Poziotinib 8 mg BID | Participants received poziotinib 8 mg orally, BID in each 28-day treatment cycle. |
|
|
| Primary | Phase 2: Objective Response Rate (ORR) | ORR was defined as the percentage of participants with best response i.e confirmed complete response (CR) and partial response (PR) as assessed by the investigator using local radiology evaluation according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. | Data for this outcome measure was not collected and analyzed as planned as the study was terminated due to the sponsor's business decision. | Posted | Up to 461 days |
|
|
| Secondary | Phase 2: Disease Control Rate (DCR) | The percentage of participants who achieve CR, PR, and stable disease (SD) by the best response from the first dose of poziotinib to the end of the study as assessed by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. | Data for this outcome measure was not collected and analyzed as planned as the study was terminated due to the sponsor's business decision. | Posted | Up to 461 days |
|
|
| Secondary | Phase 2: Duration of Response (DoR) | Duration of response was defined as the time from the date that measurement criteria are first met for CR or PR until the first subsequent date that progressive disease as assessed by the investigator according to RECIST v1.1 or death is documented. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. | Data for this outcome measure was not collected and analyzed as planned as the study was terminated due to the sponsor's business decision. | Posted | Up to 461 days |
|
|
| Secondary | Phase 2: Progression Free Survival (PFS) | PFS was the number of days from the treatment start date to the date of first documented disease progression or death from any cause. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in sum of diameters (SOD) from previous smallest SOD on study, and an absolute increase of ≥5mm. | Data for this outcome measure was not collected and analyzed as planned as the study was terminated due to the sponsor's business decision. | Posted | Up to 461 days |
|
|
| Secondary | Phase 1: Plasma Concentration of Poziotinib and M1, M2 Metabolites | Data for this outcome measure was not collected and analyzed as planned as the study was terminated due to the sponsor's business decision. | Posted | Cycle 1, Day 1 and Day 13 |
|
|
| Secondary | Phase 1 and 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs are AEs that occur from the first dose of study treatment until 40 days after the last dose of study treatment. An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. | Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib. | Posted | Number | percentage of participants | Up to 40 days after the last dose of the study drug (Up to 461 days) |
|
|
|
| Other Pre-specified | Phase 2: Exploratory - Overall Survival | The number of days from the treatment start date to the date of death due to any cause. | Not Posted | 2 years | Participants |
| 2 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Phase 1: Poziotinib 12 mg QD | Participants received poziotinib 12 mg orally, QD, in each 28-day treatment cycle. | 2 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Phase 1: Poziotinib 16 mg QD | Participants received poziotinib 16 mg orally, QD, in each 28-day treatment cycle. | 2 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Phase 1: Poziotinib 4 mg BID | Participants received poziotinib 4 mg orally, BID, in each 28-day treatment cycle. | 3 | 4 | 1 | 4 | 4 | 4 |
| EG004 | Phase 1: Poziotinib 6 mg BID | Participants received poziotinib 6 mg orally, BID, in each 28-day treatment cycle. | 2 | 6 | 1 | 6 | 6 | 6 |
| EG005 | Phase 1: Poziotinib 8 mg BID | Participants received poziotinib 8 mg orally, BID, in each 28-day treatment cycle. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG006 | Phase 2: Poziotinib 12mg QD | Participants received poziotinib 12 mg orally, QD, in each 28-day treatment cycle. | 5 | 20 | 4 | 20 | 20 | 20 |
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Urethritis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Angular Cheilitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood corticotrophin decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
|
| Cortisol decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Dependent rubor | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Purpura | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash pustular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |