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A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b Cohort A | Experimental | Participants will receive MEDI-573 10 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
|
| Phase 1b Cohort B | Experimental | Participants will receive MEDI-573 45 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
|
| Phase 1b Cohort C | Experimental | Participants will receive MEDI-573 30 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
|
| Phase 2 Arm 1 | Experimental | Participants will receive recommended dose of MEDI-573 from Phase 1b IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-573 (1 of 3 doses) | Drug | MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) | The DLT was defined as any Grade 3 or higher hematologic or non-hematologic toxicity considered to be related to MEDI-573 that occurred during the DLT evaluation period (Days 1 to 21 of Cycle 1), with the exceptions of Grade 3 fever (occurred in the absence of neutropenia and resolved to normal or baseline within 24 hours of treatment and was not considered as SAE), Grade 3 rigors/chills that responded to optimal therapy, and Grade < 4 hyperglycemia that resolved in < 24 hours. | Day 1 to Day 21 of Cycle 1 |
| Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months). | From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months) |
| Phase 1b: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573 | Participants with positive ADA to MEDI-573 are reported in the below table. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons. | Predose on Day 1 of every treatment cycle; end of treatment; Days 30, 60 and 90 post treatment; every 3 months post treatrment till end of study (approximately 15 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Perez, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Oxnard | California | 93030 | United States | ||
| Research Site |
Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. No participants were randomized in Phase 1b Cohort C part of the study as no dose limiting toxicity was observed in Phase 1b Cohort B.
The study was conducted in the USA.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b Cohort A | Participants received MEDI-573 10 mg/kg intravenous infusion (IV) on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
| FG001 | Phase 1b Cohort B | Participants received MEDI-573 45 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
| FG002 | Phase 1b Cohort C | Participants were planned to receive MEDI-573 30 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
| FG003 | Phase 2 Arm 1 | Participants were planned to receive recommended dose of MEDI-573 from Phase 1b IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
| FG004 | Phase 2 Arm 2 | Participants were planned to receive sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received any amount of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b Cohort A | Participants received MEDI-573 10 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
| 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 | Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) | The DLT was defined as any Grade 3 or higher hematologic or non-hematologic toxicity considered to be related to MEDI-573 that occurred during the DLT evaluation period (Days 1 to 21 of Cycle 1), with the exceptions of Grade 3 fever (occurred in the absence of neutropenia and resolved to normal or baseline within 24 hours of treatment and was not considered as SAE), Grade 3 rigors/chills that responded to optimal therapy, and Grade < 4 hyperglycemia that resolved in < 24 hours. | Evaluable population included all participants enrolled in the Phase 1b who received at least 1 full dose of MEDI-573, received sorafenib treatment per standard practice during the DLT evaluation period, and completed safety follow-up through the DLT evaluation period or experienced any DLTs during the DLT evaluation period. | Posted | Count of Participants | Participants | Day 1 to Day 21 of Cycle 1 |
|
All AEs were reported during safety follow-up period (from the start of study treatment [Day 1] through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first) (approximately 15 months).
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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 | Phase 1b Cohort A | Participants received MEDI-573 10 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
Phase 2 part of the study was not launched by the sponsor due to strategic business reasons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Dar | MedImmune LLC | +301-398-0000 | information.center@astrazeneca.com |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000601324 | dusigitumab |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Phase 2 Arm 2 | Active Comparator | Participants will receive sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
|
| Sorafenib | Drug | Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor |
|
| From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months) |
| Phase 1b: Number of Participants With Vital Signs Abnormalities Reported as TEAEs | An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months). | From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months) |
| Phase 1b: Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs | An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months). | From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months) |
| Phase 2: Time to Progression | Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated. | From Day 1 until documentation of progressive disease (approximately 15 months) |
| Phase 2: Best Overall Tumor Response | Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated. | From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months) |
| Phase 2: Objective Response Rate | Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated. | From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months) |
| Phase 2: Progression-free Survival (PFS) | Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated. | From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months) |
| Phase 2: Change in Tumor Size | Phase 2 part the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated. | From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months) |
| Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1 | The tmax is defined as actual sampling time to reach maximum observed serum concentration of the study drug. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons. | Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose) |
| Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1 | The Cmax is the maximum observed serum concentration of study drug. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons. | Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose) |
| Phase 1b and Phase 2: Area Under Serum Concentration-time Curve From Time Zero to Day 22 (AUC0-Day22) of MEDI-573 for Cycle 1 | Area under the concentration-time curve from time zero to Day 22 is reported. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons. | Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose) |
| Golden Springs |
| Colorado |
| 80401 |
| United States |
| Research Site | Las Vegas | Nevada | 89169 | United States |
| Phase 1b Cohort B |
Participants received MEDI-573 45 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received MEDI-573 10 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
| OG001 | Phase 1b Cohort B | Participants received MEDI-573 45 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. |
|
|
| Primary | Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months). | Safety population included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months) |
|
|
|
| Primary | Phase 1b: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months). | Safety population included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months) |
|
|
|
| Primary | Phase 1b: Number of Participants With Vital Signs Abnormalities Reported as TEAEs | An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months). | Safety population included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months) |
|
|
|
| Primary | Phase 1b: Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs | An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months). | Safety population included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months) |
|
|
|
| Primary | Phase 2: Time to Progression | Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated. | Safety population included all participants who received any amount of study treatment. | Posted | From Day 1 until documentation of progressive disease (approximately 15 months) |
|
|
| Secondary | Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573 | Participants with positive ADA to MEDI-573 are reported in the below table. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons. | Safety population included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | Predose on Day 1 of every treatment cycle; end of treatment; Days 30, 60 and 90 post treatment; every 3 months post treatrment till end of study (approximately 15 months) |
|
|
|
| Secondary | Phase 2: Best Overall Tumor Response | Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated. | Safety population included all participants who received any amount of study treatment. | Posted | From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months) |
|
|
| Secondary | Phase 2: Objective Response Rate | Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated. | Safety population included all participants who received any amount of study treatment. | Posted | From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months) |
|
|
| Secondary | Phase 2: Progression-free Survival (PFS) | Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated. | Safety population included all participants who received any amount of study treatment. | Posted | From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months) |
|
|
| Secondary | Phase 2: Change in Tumor Size | Phase 2 part the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated. | Safety population included all participants who received any amount of study treatment. | Posted | From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months) |
|
|
| Secondary | Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1 | The tmax is defined as actual sampling time to reach maximum observed serum concentration of the study drug. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons. | Safety population included all participants who received any amount of study treatment. | Posted | Median | Full Range | Hours | Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose) |
|
|
|
| Secondary | Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1 | The Cmax is the maximum observed serum concentration of study drug. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons. | Safety population included all participants who received any amount of study treatment. | Posted | Mean | Standard Deviation | mcg/mL | Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose) |
|
|
|
| Secondary | Phase 1b and Phase 2: Area Under Serum Concentration-time Curve From Time Zero to Day 22 (AUC0-Day22) of MEDI-573 for Cycle 1 | Area under the concentration-time curve from time zero to Day 22 is reported. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons. | Safety population included all participants who received any amount of study treatment. | Posted | Mean | Standard Deviation | day*mcg/mL | Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose) |
|
|
|
| 2 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Phase 1b Cohort B | Participants received MEDI-573 45 mg/kg IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. | 2 | 3 | 1 | 3 | 3 | 3 |
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Scleral haemorrhage | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Implant site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diastolic hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Anemia |
|
| Blood bilirubin increased |
|
| Lipase increased |
|
| Hyperbilirubinemia |
|
| Aspartate aminotransferase increased |
|
| Hypophosphataemia |
|
| Hypoalbuminaemia |
|
| Alanine aminotransferase increased |
|
| Amylase increased |
|
| Blood alkaline phosphatase increased |
|
| Blood creatinine increased |
|
| Blood uric acid increased |
|
| Gamma-glutamyltransferase increased |
|
| Hypercholesterolaemia |
|
| Hypocalcaemia |
|
| Hypoglycaemia |
|
| Hypomagnesaemia |
|
| Hematuria |
|
| Proteinuria |
|
| Diastolic hypertension |
|