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| ID | Type | Description | Link |
|---|---|---|---|
| H8Z-MC-JACU | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to understand the safety profile of LY2181308 sodium administered in combination with idarubicin and cytarabine to patients with relapsed or refractory acute myeloid leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2181308 sodium, idarubicin, cytarabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2181308 sodium | Drug | 750 milligrams (mg) is administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 (28 days) and Days 1, 8, 15, 22 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (Safety Profile) | Data are presented as number of participants who experienced serious adverse events (SAE) and possibly drug-related treatment-emergent adverse events (TEAE) during the study including the 21-day follow-up period. A summary of serious adverse events and other nonserious adverse events regardless of causality is located in the Reported Adverse Events section. | Start of treatment to study completion up to 6.7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response to LY2181308 Sodium in Combination With Idarubicin and Cytarabine (Remission Rates) | Response is complete remission (CR) + CR with incomplete blood count recovery (CRi) + partial remission (PR) + cytoreduction. CR: fewer than 5% blasts based on a cell count of at least 200 cells from a bone marrow aspirate containing bone marrow spicules, in the setting of peripheral blood recovery to: platelets ≥100x10⁹/liter (L), neutrophils ≥10⁹/L. PR: defined as a decrease of at least 50% in blast count on the bone marrow aspirate; or cytoreduction (defined as a decrease in blast count not meeting the criteria for a PR or CR). Response rate is calculated as a total number of participants with CR or CRi or PR or cytoreduction divided by the total number of participants treated multiplied by 100. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died Due to Progressive Disease or Unknown Cause During the 21 Days Post Study Treatment Follow-Up | Deaths due to progressive disease (PD) and unknown cause are not considered adverse events. Deaths due to PD and unknown cause occurring during the 21-day follow-up period after treatment discontinuation are reported here and for those occurring while participants were on treatment are reported in the Participant Flow. Deaths due to serious adverse events occurred during the study including the 21-day follow-up period are reported in the Reported Adverse Events section. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT-5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ann Arbor | Michigan | 48105 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23397500 | Result | Erba HP, Sayar H, Juckett M, Lahn M, Andre V, Callies S, Schmidt S, Kadam S, Brandt JT, Van Bockstaele D, Andreeff M. Safety and pharmacokinetics of the antisense oligonucleotide (ASO) LY2181308 as a single-agent or in combination with idarubicin and cytarabine in patients with refractory or relapsed acute myeloid leukemia (AML). Invest New Drugs. 2013 Aug;31(4):1023-34. doi: 10.1007/s10637-013-9935-x. Epub 2013 Feb 10. |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
The reasons for discontinuation listed in the Participant Flow are the reasons the participant discontinued treatment. All participants who have completed at least 1 cycle of study drug were considered to have completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2181308 | 750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days. |
| FG001 | LY2181308 + Idarubicin + Cytarabine | LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond. Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond. Cycle length: 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2181308 | 750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days. |
| BG001 | LY2181308 + Idarubicin + Cytarabine |
| 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 With Adverse Events (Safety Profile) | Data are presented as number of participants who experienced serious adverse events (SAE) and possibly drug-related treatment-emergent adverse events (TEAE) during the study including the 21-day follow-up period. A summary of serious adverse events and other nonserious adverse events regardless of causality is located in the Reported Adverse Events section. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Start of treatment to study completion up to 6.7 months |
|
Not provided
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
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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 | LY2181308 | 750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D015255 | Idarubicin |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| cytarabine | Drug | 1.5 grams per square meter (g/m²) will be administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 (28 days) and Days 1, 2, 3 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops. |
|
| idarubicin | Drug | 12 milligrams per square meter (mg/m²) will be administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 (28 days) and on Days 1, 2, 3 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops. |
|
| Baseline to progression of disease or death up to 6 months |
| Relapse-Free Survival | Relapse-Free Survival was defined as the time from first objective status assessment of complete remission (CR) or CR with incomplete blood count recovery (CRi) or partial remission (PR) or cytoreduction to the first time of disease progression or death as a result of any cause. CR: fewer than 5% blasts based on a cell count of at least 200 cells from a bone marrow aspirate containing bone marrow spicules, in the setting of peripheral blood recovery to: platelets ≥100x10⁹/liter (L), neutrophils ≥10⁹/L. PR: defined as a decrease of at least 50% in blast count on the bone marrow aspirate; or cytoreduction (defined as a decrease in blast count not meeting the criteria for a PR or CR). There were too few participants who had a documented progression of disease or death event amongst the participants with a response of CR, CRi, PR or cytoreduction to conduct the time-to-event analysis, thus the relapse-free survival was not analyzed. | Baseline to progression of disease or death up to 6 months |
| Area Under the Curve of LY2181308 Over the Dosing Interval | Area under the curve of LY2181308 over the dosing interval | Day 3: 0,12,24,36,48,60,72,84,96,108,120,132 hours |
| Pharmacodynamics: Number of Participants With Survivin Protein Expression | Pharmacodynamics: Number of participants with Survivin Protein Expression. | 6 Months |
| Change From Baseline in Survivin Index at Day 2 | Data presented are the ratio of Day 2 survivin index to the baseline survivin index. Survivin is a protein expressed in tumor cells, including acute myeloid leukemia (AML), which regulates mitosis and prevents tumor cell death. Survivin index was calculated as ([blast survivin mean equivalent fluorochrome (MEFL) - blast isotypic control MEFL]/blast isotypic control MEFL). | Baseline, Day 2 |
| Study treatment discontinuation up to 21 days post study treatment discontinuation |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | 77030 | United States |
| Physician Decision |
|
| Progressive Disease |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 |
| LY2181308 + Idarubicin + Cytarabine |
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond. Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond. Cycle length: 28 days. |
|
|
| Secondary | Percentage of Participants With Response to LY2181308 Sodium in Combination With Idarubicin and Cytarabine (Remission Rates) | Response is complete remission (CR) + CR with incomplete blood count recovery (CRi) + partial remission (PR) + cytoreduction. CR: fewer than 5% blasts based on a cell count of at least 200 cells from a bone marrow aspirate containing bone marrow spicules, in the setting of peripheral blood recovery to: platelets ≥100x10⁹/liter (L), neutrophils ≥10⁹/L. PR: defined as a decrease of at least 50% in blast count on the bone marrow aspirate; or cytoreduction (defined as a decrease in blast count not meeting the criteria for a PR or CR). Response rate is calculated as a total number of participants with CR or CRi or PR or cytoreduction divided by the total number of participants treated multiplied by 100. | All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline to progression of disease or death up to 6 months |
|
|
|
| Secondary | Relapse-Free Survival | Relapse-Free Survival was defined as the time from first objective status assessment of complete remission (CR) or CR with incomplete blood count recovery (CRi) or partial remission (PR) or cytoreduction to the first time of disease progression or death as a result of any cause. CR: fewer than 5% blasts based on a cell count of at least 200 cells from a bone marrow aspirate containing bone marrow spicules, in the setting of peripheral blood recovery to: platelets ≥100x10⁹/liter (L), neutrophils ≥10⁹/L. PR: defined as a decrease of at least 50% in blast count on the bone marrow aspirate; or cytoreduction (defined as a decrease in blast count not meeting the criteria for a PR or CR). There were too few participants who had a documented progression of disease or death event amongst the participants with a response of CR, CRi, PR or cytoreduction to conduct the time-to-event analysis, thus the relapse-free survival was not analyzed. | Zero participants analyzed as no data collected on participants for relapse free survival due to no sufficient follow up on participants with response for time to event. | Posted | Baseline to progression of disease or death up to 6 months |
|
|
| Secondary | Area Under the Curve of LY2181308 Over the Dosing Interval | Area under the curve of LY2181308 over the dosing interval | All participants who received study drug and had pharmacokinetic (PK) data to calculate AUC. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Day 3: 0,12,24,36,48,60,72,84,96,108,120,132 hours |
|
|
|
| Secondary | Pharmacodynamics: Number of Participants With Survivin Protein Expression | Pharmacodynamics: Number of participants with Survivin Protein Expression. | All participants who received at least one dose of study drug. Per protocol amendment, Survivin Protein Expression change was assessed for LY2181308 arm only. | Posted | Count of Participants | Participants | No | 6 Months |
|
|
|
| Secondary | Change From Baseline in Survivin Index at Day 2 | Data presented are the ratio of Day 2 survivin index to the baseline survivin index. Survivin is a protein expressed in tumor cells, including acute myeloid leukemia (AML), which regulates mitosis and prevents tumor cell death. Survivin index was calculated as ([blast survivin mean equivalent fluorochrome (MEFL) - blast isotypic control MEFL]/blast isotypic control MEFL). | All participants who received at least one dose of study drug and had both baseline and Day 2 survivin index measurements. Per protocol amendment, only participants in LY2181308 arm were analyzed for Survivin Index. | Posted | Least Squares Mean | 90% Confidence Interval | ratio | Baseline, Day 2 |
|
|
|
| Other Pre-specified | Number of Participants Who Died Due to Progressive Disease or Unknown Cause During the 21 Days Post Study Treatment Follow-Up | Deaths due to progressive disease (PD) and unknown cause are not considered adverse events. Deaths due to PD and unknown cause occurring during the 21-day follow-up period after treatment discontinuation are reported here and for those occurring while participants were on treatment are reported in the Participant Flow. Deaths due to serious adverse events occurred during the study including the 21-day follow-up period are reported in the Reported Adverse Events section. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Study treatment discontinuation up to 21 days post study treatment discontinuation |
|
|
|
| 6 |
| 8 |
| 8 |
| 8 |
| EG001 | LY2181308 + Idarubicin + Cytarabine | LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond. Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond. Cycle length: 28 days. | 13 | 16 | 16 | 16 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA 13.0 | Systematic Assessment | Event resulted in 1 death in the LY2181308+Cytarabine+Idarubicin arm during the post-therapy follow-up period. |
|
| Clostridial infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment | Event resulted in 1 death in the LY2181308 arm during the treatment period. |
|
| Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment | Event resulted in 3 deaths in the LY2181308 arm during the post-therapy follow-up period. |
|
| Septic shock | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment | Event resulted in 2 deaths in the LY2181308+Cytarabine+Idarubicin arm; 1 death during the treatment period and 1 death during the post-therapy follow-up period. |
|
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal rebound tenderness | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gingival disorder | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rectal fissure | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tongue coated | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Crepitations | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Epiglottitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Infusion site infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Glomerular filtration rate | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |