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| ID | Type | Description | Link |
|---|---|---|---|
| CP12-0712 | Other Identifier | ImClone Systems | |
| I4T-IE-JVBK | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine if Ramucirumab (IMC-1121B) causes prolongation of the QT/QTc interval in participants with advanced cancer.
The primary purpose of this study is to determine if treatment with ramucirumab causes prolongation of the QTc/QT interval in participants with advanced cancer, to assess the safety and tolerability of ramucirumab therapy, and to evaluate the pharmacokinetic (PK) characteristics of ramucirumab
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-1121B | Experimental | Active-control participants (first 16 participants) will receive one dose of moxifloxacin orally 7 days before the first treatment with ramucirumab. All participants will undergo triplicate electrocardiogram (ECG) tests (consisting of three individual ECGs performed consecutively within a period of 4 minutes) and vital signs at various times over the trial period. For Cycle 1, all participants will also receive 2 infusions of diphenhydramine before ramucirumab therapy (the first infusion is 1 day before therapy and the second infusion is 15 minutes before therapy). For Cycles 2, 3, and 4, all participants will receive diphenhydramine 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, diphenhydramine infusions before ramucirumab therapy are at the investigator's discretion. Ramucirumab [10 milligrams per kilogram (mg/kg)] intravenously over 60 minutes, once every 3 weeks for minimum of 9 weeks without a break in between. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-1121B | Biological | IMC-1121B (Ramucirumab) 10 mg/kg intravenously (IV) over 60 minutes, once every 3 weeks for minimum of 9 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Cycle 3 in QT/Corrected QT (QTc) Interval Prolongation in Participants | All electrocardiogram (ECG) tests were performed in triplicate prior to ramucirumab treatment. QT is the interval between the Q and T waves and QTc is the QT corrected for heart rate using Fridericia's formula: QTc = QT/RR^0.33 where RR is the interval between 2 R waves. Each participant's mean QT/QTc value was calculated for each ECG test during Cycle 3 and compared to his/her mean pretreatment QT/QTc value. The greatest change from baseline during Cycle 3 was reported. QTc prolongation is defined as a QTc exceeding 10 milliseconds (msec) with a lower 90% confidence interval (CI) exceeding 5 msec at any postdose time points per the International Conference on Harmonization (ICH) E14 guidelines for non-thorough QT studies (ICH 2005; ICH 2008). Least squares (LS) mean was calculated using a linear mixed model for repeated measures (MMRM) and adjusted for serum concentration. | Baseline, Cycle 3 (1 cycle=21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug-Related Adverse Events (AEs) | Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section. |
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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 |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Atlanta | Georgia | 30322 | United States | ||
| ImClone Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26984445 | Derived | Olszanski AJ, Smith DC, Camacho LH, Thompson J, Ramalingam SS, Harvey RD, Campos L, Ferry D, Tang S, Gao L, Safran H. Electrocardiographic Characterization of Ramucirumab on the Corrected QT Interval in a Phase II Study of Patients With Advanced Solid Tumors. Oncologist. 2016 Apr;21(4):402-3. doi: 10.1634/theoncologist.2015-0467. Epub 2016 Mar 16. |
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68 participants signed the informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | IMC-1121B (Ramucirumab) | Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity. Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points. Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population: Participants who received any quantity of ramucirumab, regardless of their eligibility for the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | IMC-1121B (Ramucirumab) | Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity. Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points. Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Cycle 3 in QT/Corrected QT (QTc) Interval Prolongation in Participants | All electrocardiogram (ECG) tests were performed in triplicate prior to ramucirumab treatment. QT is the interval between the Q and T waves and QTc is the QT corrected for heart rate using Fridericia's formula: QTc = QT/RR^0.33 where RR is the interval between 2 R waves. Each participant's mean QT/QTc value was calculated for each ECG test during Cycle 3 and compared to his/her mean pretreatment QT/QTc value. The greatest change from baseline during Cycle 3 was reported. QTc prolongation is defined as a QTc exceeding 10 milliseconds (msec) with a lower 90% confidence interval (CI) exceeding 5 msec at any postdose time points per the International Conference on Harmonization (ICH) E14 guidelines for non-thorough QT studies (ICH 2005; ICH 2008). Least squares (LS) mean was calculated using a linear mixed model for repeated measures (MMRM) and adjusted for serum concentration. | Participants who received a full study dose of ramucirumab in Cycle 3 and had at least 1 pretreatment ECG and postinfusion ECG at scheduled times as specified in the protocol. | Posted | Least Squares Mean | 90% Confidence Interval | milliseconds (msec) | Baseline, Cycle 3 (1 cycle=21 days) |
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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 | IMC-1121B (Ramucirumab) | Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity. Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points. Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D000077266 | Moxifloxacin |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Moxifloxacin | Drug | Administered orally |
|
| Diphenhydramine | Drug | Administered IV |
|
| Baseline up to data cut off (approximately 105.6 weeks) |
| Maximum Concentration (Cmax) During Cycle 1 | Maximum observed concentration of IMC-1121B (ramucirumab) in serum during Cycle 1 (1 cycle=21 days). | Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose] |
| Maximum Concentration (Cmax) During Cycle 1, Day 4 | Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1. | Approximately Week 1 (Cycle 1, Day 4) |
| Maximum Concentration (Cmax) During Cycle 1, Day 8 | Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1. | Approximately Week 2 (Cycle 1, Day 8) |
| Maximum Concentration (Cmax) During Cycle 1, Day 15 | Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1. | Approximately Week 3 (Cycle 1, Day 15) |
| Maximum Concentration (Cmax) During Cycle 2 | Cmax was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1. | Cycle 2 (predose and 1.25 hours postdose) |
| Maximum Concentration (Cmax) During Cycle 3 | The maximum observed serum concentration of IMC-1121B (ramucirumab) at steady state (Cmax,ss) during Cycle 3 (1 cycle=21 days). | Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose] |
| Area Under Concentration (AUC) During Cycle 1 | The area under the concentration versus time curve from time 0 to infinity [AUC(0-inf)] is reported during Cycle 1 (1 cycle=21 days). | Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose] |
| Area Under Concentration (AUC) During Cycle 1, Day 4 | AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15). | Approximately Week 1 (Cycle 1, Day 4) |
| Area Under Concentration (AUC) During Cycle 1, Day 8 | AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15). | Approximately Week 2 (Cycle 1, Day 8) |
| Area Under Concentration (AUC) During Cycle 1, Day 15 | AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15). | Approximately Week 3 (Cycle 1, Day 15) |
| Area Under Concentration (AUC) During Cycle 2, Day 1 | AUC was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1. | Approximately Week 1 (Cycle 2, Day 1) |
| Area Under Concentration (AUC) During Cycle 3 | The area under the concentration versus time curve over the dosing interval at steady state [AUC(tau,ss)] is reported during Cycle 3 (1 cycle=21 days). | Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose] |
| Metairie |
| Louisiana |
| 70006 |
| United States |
| ImClone Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| ImClone Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| ImClone Investigational Site | Providence | Rhode Island | 02903 | United States |
| ImClone Investigational Site | Houston | Texas | 77024 | United States |
| ImClone Investigational Site | Seattle | Washington | 98109 | United States |
| Adverse Event |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Ethnicity | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | IMC-1121B (Ramucirumab) | Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity. Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points. Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab. |
|
|
|
| Secondary | Number of Participants With Drug-Related Adverse Events (AEs) | Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section. | Safety population: participants who received any quantity of ramucirumab, regardless of their eligibility for the study. | Posted | Number | participants | Baseline up to data cut off (approximately 105.6 weeks) |
|
|
|
| Secondary | Maximum Concentration (Cmax) During Cycle 1 | Maximum observed concentration of IMC-1121B (ramucirumab) in serum during Cycle 1 (1 cycle=21 days). | Participants who received a full dose of ramucirumab and have evaluable Cmax data during Cycle 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose] |
|
|
|
| Secondary | Maximum Concentration (Cmax) During Cycle 1, Day 4 | Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1. | No participants were analyzed. | Posted | Approximately Week 1 (Cycle 1, Day 4) |
|
|
| Secondary | Maximum Concentration (Cmax) During Cycle 1, Day 8 | Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1. | No participants were analyzed. | Posted | Approximately Week 2 (Cycle 1, Day 8) |
|
|
| Secondary | Maximum Concentration (Cmax) During Cycle 1, Day 15 | Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1. | No participants were analyzed. | Posted | Approximately Week 3 (Cycle 1, Day 15) |
|
|
| Secondary | Maximum Concentration (Cmax) During Cycle 2 | Cmax was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1. | No participants were analyzed. | Posted | Cycle 2 (predose and 1.25 hours postdose) |
|
|
| Secondary | Maximum Concentration (Cmax) During Cycle 3 | The maximum observed serum concentration of IMC-1121B (ramucirumab) at steady state (Cmax,ss) during Cycle 3 (1 cycle=21 days). | Participants who received a full dose of ramucirumab and have evaluable Cmax data during Cycle 3. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose] |
|
|
|
| Secondary | Area Under Concentration (AUC) During Cycle 1 | The area under the concentration versus time curve from time 0 to infinity [AUC(0-inf)] is reported during Cycle 1 (1 cycle=21 days). | Participants who received a full dose of ramucirumab and have evaluable AUC data during Cycle 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*micrograms/milliliter (h*mcg/mL) | Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose] |
|
|
|
| Secondary | Area Under Concentration (AUC) During Cycle 1, Day 4 | AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15). | No participants were analyzed. | Posted | Approximately Week 1 (Cycle 1, Day 4) |
|
|
| Secondary | Area Under Concentration (AUC) During Cycle 1, Day 8 | AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15). | No participants were analyzed. | Posted | Approximately Week 2 (Cycle 1, Day 8) |
|
|
| Secondary | Area Under Concentration (AUC) During Cycle 1, Day 15 | AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15). | No participants analyzed. | Posted | Approximately Week 3 (Cycle 1, Day 15) |
|
|
| Secondary | Area Under Concentration (AUC) During Cycle 2, Day 1 | AUC was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1. | No participants were analyzed. | Posted | Approximately Week 1 (Cycle 2, Day 1) |
|
|
| Secondary | Area Under Concentration (AUC) During Cycle 3 | The area under the concentration versus time curve over the dosing interval at steady state [AUC(tau,ss)] is reported during Cycle 3 (1 cycle=21 days). | Participants who received a full dose of ramucirumab and have evaluable AUC data during Cycle 3. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*micrograms/milliliter (h*mcg/mL) | Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose] |
|
|
|
| 32 |
| 66 |
| 61 |
| 66 |
| Anaemia megaloblastic | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Title | Measurements |
|---|---|
|
| Related AE leading to discontinuation |
|