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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Sun Yat-sen University | OTHER |
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Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced Colorectal Cancer (CRC) in Phase Ib study.
This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after metastatic CRC second line or above standard chemotherapy.
This is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial to compare the efficacy and safety of Fruquintinib plus Best Supportive Care (BSC) versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy.
After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1.
Primary Efficacy Endpoint:
Progression free survival (PFS) (According to RECIST Version 1.1).
Secondary Efficacy Endpoints:
Objective Response Rate (ORR), Disease Control Rate (DCR), Overall Survival (OS).
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI common terminology criteria for adverse events (CTC AE) Version 4.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Active Comparator | treatment arm- subjects will receive Fruquintinib 5mg orally, once daily (QD), plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. |
|
| control arm | Placebo Comparator | control arm- subjects will receive Fruquintinib placebo 5mg orally, once daily (QD), plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fruquintinib | Drug | fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS refers to the time interval between the randomization date and the initial record of PD or date of death, whichever is earlier. The presence of PD shall be determined in accordance with the result of the evaluation performed by the investigator, using with RECIST v1.1 criteria. The date of final tumor evaluation will be used as the censoring date for subjects who have not presented with disease progression or death by that date. The date of randomization will be used as the censoring date for subjects which have no death and post-baseline tumor evaluation. If a subject has no post-baseline tumor evaluation but recorded as dead, death will be count as PFS event. | From randomization until the date of first documented progression or date of death from any cause, whichever came first. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The ORR is defined as the rate of complete response (CR) or partial response (PR) as the best overall response (BOR), based on evaluation of target lesions and non-target lesions with corroborant radiological method and determined by RECIST v1.1, for the ITT set of response evaluable subjects. Subjects who have no post-baseline tumor evaluation shall be regarded as subjects without ORR. Subjects who qualify for evaluation of CR or PR should have at least one available lesion for measurement with RECIST v1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Li, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hutchison Medi Pharma Investigational Site | Beijing | Beijing Municipality | 100071 | China | ||
| Hutchison Medi Pharma Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28103904 | Result | Xu RH, Li J, Bai Y, Xu J, Liu T, Shen L, Wang L, Pan H, Cao J, Zhang D, Fan S, Hua Y, Su W. Safety and efficacy of fruquintinib in patients with previously treated metastatic colorectal cancer: a phase Ib study and a randomized double-blind phase II study. J Hematol Oncol. 2017 Jan 19;10(1):22. doi: 10.1186/s13045-016-0384-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | treatment arm- subjects will receive Fruquintinib 5mg orally, Once Daily (QD), plus Best Supportive Care (BSC) for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off |
| FG001 | Control Arm | control arm- subjects will receive Fruquintinib placebo 5mg orally, Once Daily (QD), plus Best Supportive Care (BSC) for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Progression Free Survival (PFS) | PFS refers to the time interval between the randomization date and the initial record of PD or date of death, whichever is earlier. The presence of PD shall be determined in accordance with the result of the evaluation performed by the investigator, using with RECIST v1.1 criteria. The date of final tumor evaluation will be used as the censoring date for subjects who have not presented with disease progression or death by that date. The date of randomization will be used as the censoring date for subjects which have no death and post-baseline tumor evaluation. If a subject has no post-baseline tumor evaluation but recorded as dead, death will be count as PFS event. | The intention-to-treat set will contain all subjects in the Randomized set (RND) set subjects will be classified according to randomized treatment. The intent-to-treat principle is preserved. The Intention to Treat (ITT) will be used for analyses of PFS, OS, ORR and DCR. | Posted | Median | 95% Confidence Interval | months | From randomization until the date of first documented progression or date of death from any cause, whichever came first. |
|
Adverse event (AE) should be collected from first dose to 30 days after EOT. AEs and laboratory abnormalities that could not be restored or unexplained needed to be collected till recovery or until they could be explained. Serious adverse event (SAE) was collected from informed consent. Only SAEs related to the study drugs should be collected until 30 days after the last dose.
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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 | Treatment Arm | treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Songhua Fan | Hutchison Medipharma Ltd | +86 21 2067 3058 | 5058 | songhuaf@hmplglobal.com |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
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| placebo | Drug | Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off |
|
|
| From randomization up to progressive disease or end of treatment (EOT) due to any cause. |
| Disease Control Rate (DCR) | The DCR is defined as the rate of corroborant CR, PR and stable disease (SD) as the BOR, based on evaluation of target lesions and non-target lesions with corroborant radiological method and determined according to RECIST v1.1, for the ITT set of response evaluable subjects. | From randomization up to progressive disease or EOT due to any cause. |
| Over Survival (OS) | The OS refers to the time interval between the randomization date and the date of death (any cause). The final known date of survival will be used as the censoring date for subjects that have not been reported to have died by the time of analysis. | From randomization until death due to any cause. |
| Guangzhou |
| Guangdong |
| 510060 |
| China |
| Hutchison Medi Pharma | Harbin | Heilongjiang | 150081 | China |
| Hutchison Medi Pharma Investigational Site | Hangzhou | Zhejiang | 310016 | China |
| Hutchison Medi Pharma Investigational Site | Shanghai | 200032 | China |
| BG001 | Control Arm | control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Treatment Arm | treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off |
| OG001 | Control Arm | control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off |
|
|
| Secondary | Objective Response Rate (ORR) | The ORR is defined as the rate of complete response (CR) or partial response (PR) as the best overall response (BOR), based on evaluation of target lesions and non-target lesions with corroborant radiological method and determined by RECIST v1.1, for the ITT set of response evaluable subjects. Subjects who have no post-baseline tumor evaluation shall be regarded as subjects without ORR. Subjects who qualify for evaluation of CR or PR should have at least one available lesion for measurement with RECIST v1.1. | Posted | Count of Participants | Participants | From randomization up to progressive disease or end of treatment (EOT) due to any cause. |
|
|
|
| Secondary | Disease Control Rate (DCR) | The DCR is defined as the rate of corroborant CR, PR and stable disease (SD) as the BOR, based on evaluation of target lesions and non-target lesions with corroborant radiological method and determined according to RECIST v1.1, for the ITT set of response evaluable subjects. | Posted | Count of Participants | Participants | From randomization up to progressive disease or EOT due to any cause. |
|
|
|
| Secondary | Over Survival (OS) | The OS refers to the time interval between the randomization date and the date of death (any cause). The final known date of survival will be used as the censoring date for subjects that have not been reported to have died by the time of analysis. | Posted | Median | 95% Confidence Interval | months | From randomization until death due to any cause. |
|
|
|
| 38 |
| 47 |
| 12 |
| 47 |
| 47 |
| 47 |
| EG001 | Control Arm | control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off | 19 | 24 | 5 | 24 | 20 | 24 |
| Embolism arterial | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Obstruction intestinal | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Functional ileus | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hepatic damage | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Platelet count decreased | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hepatic coma | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD THYROID STIMULATING HORMONE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| OCCULT BLOOD POSITIVE | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD PRESSURE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD URINE PRESENT | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD POTASSIUM DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| NAIL DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| PROTEINURIA | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| TINNITUS | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
|
| HEPATIC PAIN | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPOTHYROIDISM | Endocrine disorders | MedDRA (17.1) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |