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| ID | Type | Description | Link |
|---|---|---|---|
| OPT-80-302 | Other Identifier | Optimerpharma Study Number |
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The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell transplantation (HSCT). The primary hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants undergoing HSCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fidaxomicin | Active Comparator | 200 mg Fidaxomicin tablet once daily for no longer than 40 days |
|
| Placebo | Placebo Comparator | Placebo tablet once daily for no longer than 40 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fidaxomicin | Drug | Fidaxomicin 200 mg tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Study drug treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later). Study drug treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up. | CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented. | Up to 30 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment. | CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36906440 | Derived | de Almeida C, Wong M, Kleijn HJ, Wrishko RE. Predicted Bezlotoxumab Exposure in Patients Who Have Received a Hematopoietic Stem Cell Transplant. Clin Ther. 2023 Apr;45(4):356-362. doi: 10.1016/j.clinthera.2023.02.006. Epub 2023 Mar 9. | |
| 29893798 | Derived | Mullane KM, Winston DJ, Nooka A, Morris MI, Stiff P, Dugan MJ, Holland H, Gregg K, Adachi JA, Pergam SA, Alexander BD, Dubberke ER, Broyde N, Gorbach SL, Sears PS. A Randomized, Placebo-controlled Trial of Fidaxomicin for Prophylaxis of Clostridium difficile-associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation. Clin Infect Dis. 2019 Jan 7;68(2):196-203. doi: 10.1093/cid/ciy484. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fidaxomicin | 200 mg Fidaxomicin tablet once daily for no longer than 40 days |
| FG001 | Placebo | Placebo tablet once daily for no longer than 40 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Placebo | Drug | Placebo tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later). Treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days. |
|
| Up to 60 days post-treatment |
| Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study. | CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented. | Up to Day 70 of study |
| Treated |
|
| Safety Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified Intent-to-Treat (mITT) consisting of all randomized participants undergoing hematopoietic stem cell transplantation (HSCT) who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fidaxomicin | 200 mg Fidaxomicin tablet once daily for no longer than 40 days |
| BG001 | Placebo | Placebo tablet once daily for no longer than 40 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up. | CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented. | mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 30 days post-treatment |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment. | CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented. | mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 60 days post-treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study. | CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented. | mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Day 70 of study |
|
|
Non-serious adverse events (AEs) up to 32 days post treatment. Serious AEs (SAEs) up to 62 days post treatment.
Participants who received at least one dose of study drug. One participant randomized to Fidaxomicin, received placebo instead.
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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 | Fidaxomicin | 200 mg Fidaxomicin tablet once daily for no longer than 40 days | 98 | 300 | 297 | 300 | ||
| EG001 | Placebo | Placebo tablet once daily for no longer than 40 days | 92 | 300 | 298 | 300 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Splenic haemorrhage | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute graft versus host disease in intestine | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute graft versus host disease in skin | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Engraftment syndrome | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Graft versus host disease in intestine | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Graft versus host disease in lung | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Graft versus host disease in skin | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Aspergillosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cellulitis gangrenous | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Enterobacter bacteraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Human herpesvirus 6 infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Viraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Viral haemorrhagic cystitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Drug dispensing error | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Transplant failure | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fluid imbalance | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Central nervous system lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Peripheral T-cell lymphoma unspecified recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Autonomic neuropathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemodynamic instability | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Venoocclusive disease | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
Any publication or other public presentation of results from this study requires prior review and written approval of the Sponsor. Draft abstracts, manuscripts, and materials for presentation at scientific meetings should be provided to the Sponsor at least 90 working days prior to abstract or other relevant submission deadlines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077732 | Fidaxomicin |
| C487655 | OPT 80 |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061065 | Polyketides |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
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