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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005194-27 | EudraCT Number | ||
| U1111-1260-2961 | Other Identifier | WHO |
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The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS). The trial will also investigate whether glepaglutide is safe during long-term use. All participants in the trial will receive glepaglutide injections.
Participants will have 14 visits with the study doctor. At 2 of these, participants will spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks of treatment with glepaglutide. At all visits, participants will meet with trial staff and will have blood tests along with other clinical checks and tests done. Participants will be asked about their health and medical history.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| once-weekly glepaglutide | Experimental | All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glepaglutide | Drug | Glepaglutide will be delivered in a single-use autoinjector. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Absorption of Wet Weight/Fluids | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | from Week 0 (baseline) to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Absorption of Energy | Oral intake minus fecal excretion: measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. Energy absorption was measured by bomb calorimetry. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zealand Pharma | Zealand Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
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A total of 12 patients were screened: 1 patient failed the screening, 1 patient was withdrawn before receiving investigational product.
The trial was conducted at a single site in Denmark. The study was planned to enroll a minimum of 6 and a maximum of 16 patients with SBS intestinal failure (SBS-IF) or SBS intestinal insufficiency (SBS-II). First patient recruited was on 10 Aug 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Once-weekly Glepaglutide | All participants received glepaglutide 10 mg once weekly for 52 weeks as injections under the skin (subcutaneous, s.c.), with a subsequent 4-week follow up period. Glepaglutide: Glepaglutide was delivered in a single-use autoinjector. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Once-weekly Glepaglutide | All participants received 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) Glepaglutide: Glepaglutide was delivered in a single-use autoinjector. |
| 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 | Change in Absorption of Wet Weight/Fluids | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | Posted | Mean | Standard Deviation | g/day | from Week 0 (baseline) to Week 24 |
|
Safety data cover the period since the first administrated dose till Week 56.
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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 | Once-weekly Glepaglutide | All participants received glepaglutide 10 mg once weekly for 52 weeks as injections under the skin (subcutaneous, s.c.) with a subsequent 4-week follow up period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of clinical operations | Zealand Pharma A/S | +45 8877 3600 | info@zealandpharma.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 | Jul 2, 2021 | Aug 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2022 | Aug 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| from Week 0 (baseline) to Week 24 |
| Change in Absorption of Carbohydrates | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | from Week 0 (baseline) to Week 24 |
| Change in Absorption of Lipids | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | from Week 0 (baseline) to Week 24 |
| Change in Absorption of Proteins | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | from Week 0 (baseline) to Week 24 |
| Change in Absorption of Sodium | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | from Week 0 (baseline) to Week 24 |
| Change in Absorption of Potassium | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | from Week 0 (baseline) to Week 24 |
| Change in Absorption of Calcium | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | from Week 0 (baseline) to Week 24 |
| Change in Absorption of Magnesium | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | from Week 0 (baseline) to Week 24 |
| Change in Weekly Parenteral Support (PS) Volume | Only for participants with Short Bowel Syndrome with Intestinal Failure (SBS-IF). PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 12 |
| Change in Weekly PS Volume | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 24 |
| Change in Weekly PS Carbohydrates | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 12 |
| Change in Weekly PS Carbohydrates | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 24 |
| Change in Weekly PS Lipids | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 12 |
| Change in Weekly PS Lipids | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 24 |
| Change in Weekly PS Proteins | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 12 |
| Change in Weekly PS Proteins | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 24 |
| Change in Weekly PS Sodium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 12 |
| Change in Weekly PS Sodium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 24 |
| Change in Weekly PS Potassium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 12 |
| Change in Weekly PS Potassium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 24 |
| Change in Weekly PS Magnesium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 12 |
| Change in Weekly PS Magnesium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | from Week 0 (baseline) to Week 24 |
| Anti-glepaglutide Antibodies | Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56 | Week 56 |
| Reactivity to ZP1848 | Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56. Anti-drug antibodies (ADA) positive samples were analyzed for reactivity to ZP1848. | Week 56 |
| Cross-reactivity to Glucagon-like Peptide-2 (GLP-2) | Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56. ADA positive samples were analyzed for cross-reactivity to glucagon-like peptide-2 (GLP-2). | Week 56 |
| Glepaglutide Neutralizing Antibodies | Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56 | Week 56 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit. |
|
|
|
| Secondary | Change in Absorption of Energy | Oral intake minus fecal excretion: measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. Energy absorption was measured by bomb calorimetry. | Posted | Mean | Standard Deviation | kJ/day | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Absorption of Carbohydrates | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | Posted | Mean | Standard Deviation | g/day | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Absorption of Lipids | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | Posted | Mean | Standard Deviation | g/day | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Absorption of Proteins | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | Posted | Mean | Standard Deviation | g/day | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Absorption of Sodium | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | Posted | Mean | Standard Deviation | mmol/day | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Absorption of Potassium | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | Posted | Mean | Standard Deviation | mmol/day | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Absorption of Calcium | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | Posted | Mean | Standard Deviation | mmol/day | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Absorption of Magnesium | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. | Posted | Mean | Standard Deviation | mmol/day | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Weekly Parenteral Support (PS) Volume | Only for participants with Short Bowel Syndrome with Intestinal Failure (SBS-IF). PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | mL | from Week 0 (baseline) to Week 12 |
|
|
|
| Secondary | Change in Weekly PS Volume | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | mL | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Weekly PS Carbohydrates | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | kJ | from Week 0 (baseline) to Week 12 |
|
|
|
| Secondary | Change in Weekly PS Carbohydrates | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | kJ | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Weekly PS Lipids | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | kJ | from Week 0 (baseline) to Week 12 |
|
|
|
| Secondary | Change in Weekly PS Lipids | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | kJ | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Weekly PS Proteins | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | kJ | from Week 0 (baseline) to Week 12 |
|
|
|
| Secondary | Change in Weekly PS Proteins | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | kJ | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Weekly PS Sodium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | mmol | from Week 0 (baseline) to Week 12 |
|
|
|
| Secondary | Change in Weekly PS Sodium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | mmol | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Weekly PS Potassium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | mmol | from Week 0 (baseline) to Week 12 |
|
|
|
| Secondary | Change in Weekly PS Potassium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | mmol | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Change in Weekly PS Magnesium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | mmol | from Week 0 (baseline) to Week 12 |
|
|
|
| Secondary | Change in Weekly PS Magnesium | Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used. | Posted | Mean | Standard Deviation | mmol | from Week 0 (baseline) to Week 24 |
|
|
|
| Secondary | Anti-glepaglutide Antibodies | Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56 | Posted | Count of Participants | Participants | Week 56 |
|
|
|
| Secondary | Reactivity to ZP1848 | Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56. Anti-drug antibodies (ADA) positive samples were analyzed for reactivity to ZP1848. | Posted | Count of Participants | Participants | Week 56 |
|
|
|
| Secondary | Cross-reactivity to Glucagon-like Peptide-2 (GLP-2) | Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56. ADA positive samples were analyzed for cross-reactivity to glucagon-like peptide-2 (GLP-2). | Posted | Count of Participants | Participants | Week 56 |
|
|
|
| Secondary | Glepaglutide Neutralizing Antibodies | Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56 | Posted | Count of Participants | Participants | Week 56 |
|
|
|
| 1 |
| 10 |
| 6 |
| 10 |
| 10 |
| 10 |
| Stoma obstruction | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pelvic fluid collection | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Stoma site abscess | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Gastrointestinal stoma output abnormal | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Gastrointestinal stoma output increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Post viral fatigue syndrome | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Stomal hernia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Stoma site dermatitis | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
|
Not provided
Not provided
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |