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| Name | Class |
|---|---|
| Clinipace Worldwide | INDUSTRY |
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The main purpose of this study is to see whether PT20 can help people with a high level of phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for kidney disease.
PT20 represents a mechanism to address many of the limitations associated with current phosphate binding agents. The available clinical and non clinical evidence suggests that PT20 binds phosphate and prevents its uptake more efficiently than other phosphate binding drugs and may therefore either reduce the pill burden associated with controlling phosphate levels, or result in lower phosphate levels with the same pill burden.
The this study is the first to investigate the efficacy and safety of PT20 in subjects with dialysis-dependent chronic kidney disease (CKD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - PT20 400 mg tid | Experimental | PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
|
| Group 2 - PT20 800 mg tid | Experimental | PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
|
| Group 3 - PT20 1600 mg tid | Experimental | PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
|
| Group 4 - PT20 3200 mg tid | Experimental | PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
|
| Group 5 - Placebo tid |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT20 | Drug | Modified ferric oxide adipate tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | The primary efficacy endpoint was the change in serum phosphate concentration from Baseline (Visit 7, Day 1) to Visit 11 (Day 29). All study specific blood samples were collected, processed and analysed using a central laboratory. | Day 1 to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in haemoglobin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment as well as the continuous, fixed covariates of Baseline concentrations for haemoglobin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoff Block, MD | Denver Nephrologist | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. | |
| 32651955 | Derived | Sampson M, Faria N, Powell JJ; PEACH study investigators. Efficacy and safety of PT20, an iron-based phosphate binder, for the treatment of hyperphosphataemia: a randomized, double-blind, placebo-controlled, dose-ranging, Phase IIb study in patients with haemodialysis-dependent chronic kidney disease. Nephrol Dial Transplant. 2021 Jul 23;36(8):1399-1407. doi: 10.1093/ndt/gfaa116. |
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Subjects underwent stratified randomisation into 1 of the 4 PT20 dose groups or equivalent placebo group based pre-randomisation serum phosphate level (ratio of 8:8:8:13:13) - serum phosphate < 7.5 mg/dL were deemed to have a lower level of serum phosphate; serum phosphate ≥ 7.5 mg/dL were deemed to have a higher level of serum phosphate.
Male/female subjects with dialysis dependent CKD on prescribed maintenance haemodialysis 3 times/week for 90d before Screening were recruited and randomised to receive PT20 or placebo. Prior to Screening, all subjects were taking at least 1 OPB for a minimum of 28d mean + serum phosphate level ≥ 4.0 mg/dL and ≤ 8.0 mg/dL for the preceding 28 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - PT20 400 mg Tid | PT20 400 mg tid (1.2 g/day) administered orally PT20: Modified ferric oxide adipate |
| FG001 | Group 2 - PT20 800 mg Tid | PT20 800 mg tid (2.4 g/day) administered orally PT20: Modified ferric oxide adipate |
| FG002 | Group 3 - PT20 1600 mg Tid | PT20 1600 mg tid (4.8 g/day) administered orally PT20: Modified ferric oxide adipate |
| FG003 | Group 4 - PT20 3200 mg Tid | PT20 3200 mg tid (9.6 g/day) administered orally PT20: Modified ferric oxide adipate |
| FG004 | Group 5 - Placebo Tid | Matched Placebo (for PT20) tid administered orally Placebo: Placebo tablets matched to each active PT20 dosage arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population - consisting of all subjects who received at least one dose of study medication and had at least one subsequent contact with the Investigator.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - PT20 400 mg Tid | PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
| BG001 |
| 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 | Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | The primary efficacy endpoint was the change in serum phosphate concentration from Baseline (Visit 7, Day 1) to Visit 11 (Day 29). All study specific blood samples were collected, processed and analysed using a central laboratory. | Intent-to-Treat (ITT) population. | Posted | Mean | Full Range | mg/dL | Day 1 to Day 29 |
|
All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event.
Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
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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 | Group 1 - PT20 400 mg Tid | PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis bacterial | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Sampson | Shield Therapeutics | +44 (0) 207 186 8500 | msampson@shieldtx.com |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007501 | Iron |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Placebo Comparator |
Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
|
|
| Placebo | Drug | Placebo tablets matched to each PT20 dose arm |
|
|
| Day 1 to Day 29 |
| Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in serum ferritin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment and week (Visit), as well as the continuous, fixed covariates of Baseline concentrations for serum ferritin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. | Day 1 to Day 29 |
| Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in transferrin saturation. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment and week, as well as the continuous, fixed covariates of Baseline concentrations for transferrin saturation. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. | Day 1 to Day 29 |
| Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in Calcium x Phosphate Product . An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment, as well as the continuous, fixed covariates of Baseline concentrations for Calcium x Phosphate Product. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. In CKD subjects (Stages 3-5), the clinical recommendation (KDOQI) is that serum calcium x phosphate product should be maintained at < 55 mg^2/dL^2 (4.4 mmol^2 /L^2). | Day 1 to Day 29 |
| Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | The GSRS assesses the impact of treatment-related GI complications. It includes 15 items divided into 5 subscales (diarrhoea, indigestion, abdominal pain, constipation, and reflux), and uses a seven-grade Likert scale to assess symptoms (1 = no discomfort at all, 7 = very severe discomfort). The total score was calculated as the average score of all 15 items. If data were missing from one or more subscales, the mean of the completed items within the subscale was to be used for the subscale score, provided that more than half of the subscale items were complete. If more than half of the items within a subscale were missing, the subscale score and overall score were also to be defined as missing. The change in overall GSRS score from Baseline (Visit 7, Day 1) to Visit 11 (Day 29) was summarised by treatment and a two-sample t-test was to be used to identify differences between the placebo and PT20 dose groups. The higher the score, the more severe the gastrointestinal symptoms. | Day 1 to Day 29 |
| Withdrawal by Subject |
|
| Hyperphosphataemia |
|
| High Ferritin levels |
|
| Group 2 - PT20 800 mg Tid |
PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
| BG002 | Group 3 - PT20 1600 mg Tid | PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
| BG003 | Group 4 - PT20 3200 mg Tid | PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
| BG004 | Group 5 - Placebo Tid | Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline Serum Phosphate Concentrations | Serum phosphate concentrations were used as stratum for randomisation. The pre-randomisation phosphate levels are summarised. | Count of Participants | Participants |
|
PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
| OG002 | Group 3 - PT20 1600 mg Tid | PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
| OG003 | Group 4 - PT20 3200 mg Tid | PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
| OG004 | Group 5 - Placebo Tid | Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study |
|
|
|
| Secondary | Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in haemoglobin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment as well as the continuous, fixed covariates of Baseline concentrations for haemoglobin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. | ITT population. | Posted | Mean | Standard Deviation | g/dL | Day 1 to Day 29 |
|
|
|
|
| Secondary | Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in serum ferritin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment and week (Visit), as well as the continuous, fixed covariates of Baseline concentrations for serum ferritin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. | ITT population. | Posted | Mean | Standard Deviation | ng/mL | Day 1 to Day 29 |
|
|
|
|
| Secondary | Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in transferrin saturation. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment and week, as well as the continuous, fixed covariates of Baseline concentrations for transferrin saturation. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. | ITT population. | Posted | Mean | Standard Deviation | percent | Day 1 to Day 29 |
|
|
|
|
| Secondary | Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in Calcium x Phosphate Product . An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment, as well as the continuous, fixed covariates of Baseline concentrations for Calcium x Phosphate Product. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. In CKD subjects (Stages 3-5), the clinical recommendation (KDOQI) is that serum calcium x phosphate product should be maintained at < 55 mg^2/dL^2 (4.4 mmol^2 /L^2). | ITT population. | Posted | Mean | Standard Deviation | mg^2/dL^2 | Day 1 to Day 29 |
|
|
|
|
| Secondary | Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) | The GSRS assesses the impact of treatment-related GI complications. It includes 15 items divided into 5 subscales (diarrhoea, indigestion, abdominal pain, constipation, and reflux), and uses a seven-grade Likert scale to assess symptoms (1 = no discomfort at all, 7 = very severe discomfort). The total score was calculated as the average score of all 15 items. If data were missing from one or more subscales, the mean of the completed items within the subscale was to be used for the subscale score, provided that more than half of the subscale items were complete. If more than half of the items within a subscale were missing, the subscale score and overall score were also to be defined as missing. The change in overall GSRS score from Baseline (Visit 7, Day 1) to Visit 11 (Day 29) was summarised by treatment and a two-sample t-test was to be used to identify differences between the placebo and PT20 dose groups. The higher the score, the more severe the gastrointestinal symptoms. | Safety Set | Posted | Mean | Standard Deviation | score on a scale | Day 1 to Day 29 |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 10 |
| 24 |
| EG001 | Group 2 - PT20 800 mg Tid | PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study | 0 | 23 | 1 | 23 | 11 | 23 |
| EG002 | Group 3 - PT20 1600 mg Tid | PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study | 0 | 22 | 1 | 22 | 13 | 22 |
| EG003 | Group 4 - PT20 3200 mg Tid | PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study | 0 | 36 | 5 | 36 | 16 | 36 |
| EG004 | Group 5 - Placebo Tid | Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study | 0 | 36 | 5 | 36 | 16 | 36 |
| Osteomyelitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Femoral artery aneurysm | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Gastro-oesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Neck pain | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
|
| Malignant hypertension | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (15.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (15.1) | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
|
Not provided
Not provided
| D008670 |
| Metals |
| ANCOVA |
| <0.001 |
| Other |
| ANCOVA |
| 0.867 |
| Other |
| Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by baseline serum ferritin concentration | ANCOVA | 0.186 | Other |
| ANCOVA |
| 0.013 |
| Other |
| Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Transferrin Saturation. | ANCOVA | <0.001 | Other |
| ANCOVA |
| <0.001 |
| Other |
| Other |
| paired z-test | 0.872 | Other |
| paired z-test | 0.288 | Other |