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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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The primary objective is to demonstrate the efficacy of ferric carboxymaltose (FCM) given in a simple dosing regimen in correcting iron deficiency anaemia (IDA), by demonstrating non-inferiority to treatment with the currently approved intravenous (IV) iron therapy of iron sucrose (IS, Venofer™) in the Chinese population. The secondary objectives are to assess the safety of FCM compared to IS in the Chinese population and to evaluate the effect of FCM compared to IS on relevant laboratory parameters (haematology, chemistry, iron parameters) in the Chinese population.
This is an open-label, randomised controlled study to assess the impact of FCM in correcting iron deficiency anaemia compared with Venofer™ (IS).
All subjects, after providing written informed consent and meeting the eligibility assessments, will receive a first dose of IV iron as either FCM or IS. A total of approximately 368 subjects (184 per group) will be enrolled. All subjects will have iron deficiency anaemia as measured by haemoglobin (Hb), serum ferritin and transferrin saturation (TSAT) at screening.
Ferric carboxymaltose will be administered as either a diluted infusion or undiluted injection (at Investigator discretion) and IS will be administered as a slow intravenous injection at a rate of 1 ml undiluted solution per minute (with each single injection of 200 mg iron) or by drip infusion. Note, for subjects randomised to receive IS dosing visits are required three times a week to achieve total iron repletion dosing as calculated using the Ganzoni formula.
For subjects randomised to FCM, the total iron requirements will be calculated at screening based on the screening Hb and subject weight. Dosing will be at baseline and, if required, at day 8 and day 15. All subjects will attend study visits at screening, baseline and thereafter at Weeks 2, 4 and 6. All subjects will attend an end of study visit (at Week 8 - or earlier if discontinued prematurely).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric carboxymaltose (FCM) | Experimental | Subjects treated with FCM given by IV injection or drip infusion |
|
| Iron sucrose (IS) | Active Comparator | Subjects treated with IS given by IV injection or drip infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric carboxymaltose | Drug | Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8 | Haemoglobin (Hb) | From baseline at any time up to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | Haemoglobin (Hb) | From Baseline to weeks 2, 4, 6 and 8 |
| Change in Hb From Baseline to Weeks 2, 4, 6, and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Jin | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Zhihua Ran | Renji Hospital Shanghai Jiaotong Uniersity School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
Subjects who provided signed and dated informed consent were screened within 7 days prior to initial treatment administration.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Carboxymaltose (FCM) | Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject Body Weight (BW) and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15. |
| FG001 | Iron Sucrose (IS) | Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demography and baseline characteristics for the Safety Set (SS) are provided. The SS was defined as all randomised subjects who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Carboxymaltose (FCM) | Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15. |
| 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 | Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8 | Haemoglobin (Hb) | Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations | Posted | Count of Participants | Participants | From baseline at any time up to Week 8 |
|
From Baseline until the End of the Study (8 weeks)
All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
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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 | Ferric Carboxymaltose (FCM) | Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urine phosphorus decreased | Investigations | MedDRA version 19.1. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VIT-IRON-2011-004 Clinical Study Team | Vifor (International) Inc. | +41 58 851 80 00 | VIT-IRON-2011-004.study@viforpharma.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 | Aug 14, 2017 | Apr 28, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2019 | Apr 28, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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Open-label, parallel design, randomised controlled multi-centre trial in Chinese subjects
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|
|
| Iron sucrose | Drug | Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose. |
|
|
Haemoglobin (Hb)
| From Baseline to weeks 2, 4, 6 and 8 |
| Participants With Iron Deficiency Correction Over Time by Treatment | Iron deficiency correction: TSAT >= 16% and serum ferritin >=100ng/mL (for subjects with underlying inflammatory disease) or >14ng/mL (for subjects with no apparent underlying inflammatory disease). | From Baseline to Weeks 2, 4, 6 and 8 |
| Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | Transferrin saturation (TSAT) | From Baseline to weeks 2, 4, 6 and 8 |
| Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | From Baseline to Weeks 2, 4, 6 and 8 |
| Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | From Baseline to weeks 2, 4, 6 and 8 |
| Participants With Any Treatment Emergent Adverse Event (TEAE) | Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participant, in particular, the number of participants with at least one TEAE until end of the trial. Please refer to the detailed tables included on the Adverse Event Module for specifics | From Baseline to the End of the study (week 8) |
| Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Diastolic Blood pressure | Baseline and weeks 2, 4, 6 and 8 |
| Body Weight at Baseline and Week 8 | Baseline and week 8 |
| Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Baseline and weeks 2, 4, 6 and 8 |
| Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Baseline and weeks 2, 4, 6 and 8 |
| Withdrawal by Subject |
|
| BG001 | Iron Sucrose (IS) | Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Haemoglobin | Mean | Standard Deviation | g/dl |
|
| Serum ferritin | Mean | Standard Deviation | ng/ml |
|
| Transferrin saturation (TSAT) | Mean | Standard Deviation | % |
|
| High-sensitivity C-reactive protein (hsCRP) | Mean | Standard Deviation | mg/l |
|
| OG001 | Iron Sucrose (IS) | Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose. |
|
|
|
| Secondary | Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | Haemoglobin (Hb) | Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations | Posted | Count of Participants | Participants | From Baseline to weeks 2, 4, 6 and 8 |
|
|
|
| Secondary | Change in Hb From Baseline to Weeks 2, 4, 6, and 8 | Haemoglobin (Hb) | Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations | Posted | Mean | Standard Deviation | g/dL | From Baseline to weeks 2, 4, 6 and 8 |
|
|
|
| Secondary | Participants With Iron Deficiency Correction Over Time by Treatment | Iron deficiency correction: TSAT >= 16% and serum ferritin >=100ng/mL (for subjects with underlying inflammatory disease) or >14ng/mL (for subjects with no apparent underlying inflammatory disease). | Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations | Posted | Count of Participants | Participants | From Baseline to Weeks 2, 4, 6 and 8 |
|
|
|
| Secondary | Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | Transferrin saturation (TSAT) | Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations | Posted | Mean | Standard Deviation | Percentage of TSAT | From Baseline to weeks 2, 4, 6 and 8 |
|
|
|
| Secondary | Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations | Posted | Mean | Standard Deviation | ng/ml | From Baseline to Weeks 2, 4, 6 and 8 |
|
|
|
| Secondary | Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received. | Posted | Mean | Standard Deviation | umol/L | From Baseline to weeks 2, 4, 6 and 8 |
|
|
|
| Secondary | Participants With Any Treatment Emergent Adverse Event (TEAE) | Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participant, in particular, the number of participants with at least one TEAE until end of the trial. Please refer to the detailed tables included on the Adverse Event Module for specifics | Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received. | Posted | Count of Participants | Participants | From Baseline to the End of the study (week 8) |
|
|
|
| Secondary | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Diastolic Blood pressure | Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received. | Posted | Mean | Standard Deviation | mmHg | Baseline and weeks 2, 4, 6 and 8 |
|
|
|
| Secondary | Body Weight at Baseline and Week 8 | Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received. | Posted | Mean | Standard Deviation | kg | Baseline and week 8 |
|
|
|
| Secondary | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received. | Posted | Mean | Standard Deviation | beats/min | Baseline and weeks 2, 4, 6 and 8 |
|
|
|
| Secondary | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received. | Posted | Mean | Standard Deviation | ºC | Baseline and weeks 2, 4, 6 and 8 |
|
|
|
| 0 |
| 187 |
| 10 |
| 187 |
| 124 |
| 187 |
| EG001 | Iron Sucrose (IS) | Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose. | 0 | 180 | 7 | 180 | 92 | 180 |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1. | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1. | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Adenomyosis | Reproductive system and breast disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Pelvic adhesions | Reproductive system and breast disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA version 19.1. | Systematic Assessment |
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| Anaphylactic shock | Immune system disorders | MedDRA version 19.1. | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA version 19.1. | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 19.1. | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA version 19.1. | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA version 19.1. | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 19.1. | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA version 19.1. | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 19.1. | Systematic Assessment |
|
| Gamma-glutamyl transferase increased | Investigations | MedDRA version 19.1. | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA version 19.1. | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA version 19.1. | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 19.1. | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 19.1. | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 19.1. | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA version 19.1. | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 19.1. | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 19.1. | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 19.1. | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA version 19.1. | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 19.1. | Systematic Assessment |
|
Not provided
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| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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