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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000729-55 | EudraCT Number | ||
| MK-8669-056 | Other Identifier | Merck Protocol Number |
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The main objectives of this trial are to determine the recommended dose of ridaforolimus for pediatric participants with advanced solid tumors by measuring the number of participants experiencing dose-limiting toxicities (DLTs) while on different doses of ridaforolimus, and to characterize the pharmacokinetics of ridaforolimus in these participants. The primary hypotheses of this study are that 1) the DLTs observed will be dose-dependent and allow for definition of a maximum tolerated dose (MTD) and 2) at a safe and well tolerated dose, ridaforolimus geometric mean (GM) Day-5 blood area under the concentration-time curve at 24 hours (AUC0-24) exceeds 75% (or 1304-ng*hr/mL) of the estimated GM Day-5, 40-mg AUC0-24 in adults.
Study-related visits concluded in August 2013. Participants who did not have disease progression, adequately tolerated therapy, and continued to meet eligibility criteria for 6 months after the enrollment period had been completed could continue treatment in an extension phase until they met discontinuation criteria or voluntarily withdrew.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridaforolimus 22 mg/m^2 | Experimental | Participants receive 22 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants can receive additional treatment in an extension phase of the study. |
|
| Ridaforolimus 28 mg/m^2 | Experimental | Participants receive 28 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants can receive additional treatment in an extension phase of the study. |
|
| Ridaforolimus 33 mg/m^2 | Experimental | Participants receive 33 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants can receive additional treatment in an extension phase of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ridaforolimus | Drug | Oral administration of 10 mg enteric-coated tablets at doses of 22 mg/m^2, 28 mg/m^2, or 33 mg/m^2 based on body surface area (BSA), once daily for 5 consecutive days each week in consecutive 28-day cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing a Dose Limiting Toxicity (DLT) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) | DLT defined using NCI-CTCAE v.4.0 as any of the following events occurring during the first 28-day cycle that were possibly, probably, or definitely study drug-related: Grade 4 neutropenia for ≥5 days; Grade 3-4 neutropenia associated with fever, antibiotics, or hospitalization for infection; Grade 4 thrombocytopenia for ≥5 days or requiring platelet transfusion; ≥Grade 3 hyperglycemia for ≥5 days despite management; ≥Grade 3 diarrhea for >24 hours despite management; ≥Grade 3 nausea or vomiting despite management; any other Grade ≥3 non-hematological toxicity persisting despite management (except alopecia, transient electrolyte abnormalities, transient Grade 3 liver function test elevations, and Grade 3 neurotoxicity for participants with baseline Grade 3 neurotoxicity); inability to complete DLT assessment period, interruption in dosing for >10 dosing days during DLT assessment period, or any delay in the initiation of the next cycle for >10 dosing days due to any related toxicity. | Cycle 1 (cycle = 28 days) |
| Area Under the Concentration-Time Curve of Ridaforolimus From Time 0 to 24 Hours (AUC0-24 hr) | AUC is a measure of the amount of drug in the blood over time. Whole blood samples were collected pre-dose (within 5 minutes of ridaforolimus administration) and post-dose at specified time points on Day 5 of the first week of Cycle 1 to determine AUC0-24 hr. | Day 5 of Cycle 1 [28-day cycle]: pre-dose (0.0 hours) and 0.5, 1.0, 2.0, 4.0, 8.0, and 24.0 hours after administration of ridaforolimus |
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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 |
|---|---|---|---|
| 27713169 | Result | Pearson AD, Federico SM, Aerts I, Hargrave DR, DuBois SG, Iannone R, Geschwindt RD, Wang R, Haluska FG, Trippett TM, Geoerger B. A phase 1 study of oral ridaforolimus in pediatric patients with advanced solid tumors. Oncotarget. 2016 Dec 20;7(51):84736-84747. doi: 10.18632/oncotarget.12450. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ridaforolimus 22 mg/m^2 | Participants received 22 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study. |
| FG001 | Ridaforolimus 28 mg/m^2 | Participants received 28 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study. |
| FG002 | Ridaforolimus 33 mg/m^2 | Participants received 33 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
| |||||||||||||||||||||
| Extension Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ridaforolimus 22 mg/m^2 | Participants received 22 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing a Dose Limiting Toxicity (DLT) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) | DLT defined using NCI-CTCAE v.4.0 as any of the following events occurring during the first 28-day cycle that were possibly, probably, or definitely study drug-related: Grade 4 neutropenia for ≥5 days; Grade 3-4 neutropenia associated with fever, antibiotics, or hospitalization for infection; Grade 4 thrombocytopenia for ≥5 days or requiring platelet transfusion; ≥Grade 3 hyperglycemia for ≥5 days despite management; ≥Grade 3 diarrhea for >24 hours despite management; ≥Grade 3 nausea or vomiting despite management; any other Grade ≥3 non-hematological toxicity persisting despite management (except alopecia, transient electrolyte abnormalities, transient Grade 3 liver function test elevations, and Grade 3 neurotoxicity for participants with baseline Grade 3 neurotoxicity); inability to complete DLT assessment period, interruption in dosing for >10 dosing days during DLT assessment period, or any delay in the initiation of the next cycle for >10 dosing days due to any related toxicity. | Participants who completed the first 28-day cycle of therapy with adequate drug exposure (>75% of planned study drug doses, exclusive of doses missed due to related toxicity), or who discontinued from the study due to a related DLT, were evaluable for DLT. | Posted | Count of Participants | Participants | Cycle 1 (cycle = 28 days) |
Up to the 17-Dec-2013 database lock (up to ~56 weeks)
All participants who received at least one dose of study treatment on the base study. Per protocol, safety data from the extension period were not included in the study database and did not contribute to the primary safety analysis.
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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 | Ridaforolimus 22 mg/m^2 | Participants received 22 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric perforation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| C515074 | ridaforolimus |
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|
| NOT COMPLETED |
|
| Ridaforolimus 28 mg/m^2 |
Participants received 28 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study. |
| BG002 | Ridaforolimus 33 mg/m^2 | Participants received 33 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Area Under the Concentration-Time Curve of Ridaforolimus From Time 0 to 24 Hours (AUC0-24 hr) | AUC is a measure of the amount of drug in the blood over time. Whole blood samples were collected pre-dose (within 5 minutes of ridaforolimus administration) and post-dose at specified time points on Day 5 of the first week of Cycle 1 to determine AUC0-24 hr. | Participants who received all 5 ridaforolimus doses in the first week of 28-day Cycle 1 were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 5 of Cycle 1 [28-day cycle]: pre-dose (0.0 hours) and 0.5, 1.0, 2.0, 4.0, 8.0, and 24.0 hours after administration of ridaforolimus |
|
|
|
| 1 |
| 4 |
| 3 |
| 4 |
| 4 |
| 4 |
| EG001 | Ridaforolimus 28 mg/m^2 | Participants received 28 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG002 | Ridaforolimus 33 mg/m^2 | Participants received 33 mg/m^2 of ridaforolimus administered orally for 5 consecutive days each week (2 days rest) in consecutive 28-day cycles for up to six months. Eligible participants could receive additional treatment in an extension phase of the study. | 1 | 13 | 7 | 13 | 13 | 13 |
| Proctalgia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Wolff-Parkinson-White syndrome | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Mydriasis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lip pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pleural infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Vulvitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood magnesium increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood phosphorus increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood selenium increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| International normalised ratio decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Reticulocyte count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyporeflexia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Enuresis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.