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| Name | Class |
|---|---|
| US Biotest, Inc. | INDUSTRY |
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This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle paclitaxel will be injected directly into tumors in the lungs of people with small cell or non-small cell lung cancer. All subjects in this study will receive NanoPac and will be evaluated to see if NanoPac is safe and has an effect on the tumor within the lung.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoPac | Experimental | Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension | Drug | NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles within a well-characterized particle-size distribution. Following PCA, NanoPac is filled into a clear 60mL Type 1, USP, clear-glass vial (306 mg/vial) as a powder fill of nanoparticulate paclitaxel, closed with a bromobutyl rubber stopper and aluminum crimp seal, and sterilized by gamma irradiation. Prior to administration at the hospital/clinic, NanoPac will be reconstituted with 1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP, to form a suspension. The suspension will be further diluted with 0.9% Sodium Chloride for Injection, USP to achieve the final clinical formulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. | Day 1 to Week 24 (6 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Paclitaxel in the Systemic Circulation Post-injection | To characterize the pharmacokinetics of intratumoral NanoPac, plasma samples were taken on days of NanoPac injection prior to injection and at 1, 2, and 4 hours after NanoPac injection, as well as at all other study visits up through Week 24. Plasma paclitaxel concentrations are reported in pg/mL. | Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24 |
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Inclusion Criteria:
Signed informed consent;
Age ≥18 years and able to tolerate the EBUS-TBNI procedure;
Histologically/cytologically confirmed lung cancer. Eligible subjects may include, for example: primary or recurrent non-resectable disease, locally advanced stages II and III with nodal disease, stage IV advanced disease;
At least one lesion documented via imaging (within 4 weeks of Screening) which can be accessed using EBUS-TBNI;
Subject is not a candidate for surgery;
Has received or plans to receive SOC chemotherapy; adequate hematologic recovery must be confirmed according to the institution's SOC;
Performance Status (ECOG) 0-2 at study entry;
Life expectancy of at least 6 months;
Adequate marrow, liver, and renal function at study entry;
Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.*
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shelagh Verco, PhD | US Biotest, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Health | Gainesville | Florida | 32610 | United States | ||
| Parkview Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | NanoPac 15 mg/mL | Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NanoPac 15 mg/mL | Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. |
| 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 Treatment Emergent Adverse Events | AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. | All subjects enrolled provided data for this outcome measure. Of the 18 subjects enrolled, one subject in the "NanoPac 15 mg/ml - One Injection" arm was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments but was included in the outcome measure of number of participants with treatment emergent adverse events. | Posted | Count of Participants | Participants | Day 1 to Week 24 (6 Months) |
|
All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
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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 | NanoPac 15 mg/mL - One Injection | Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received only one of the optional three NanoPac injections. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Mitchell | NanOlogy, LLC | 8179004074 | mark.mitchell@dfb.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2021 | Nov 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2023 | Nov 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D011208 | Powders |
| D013535 | Suspensions |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
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|
|
| Progression Free Survival (PFS) | Progression free survival (PFS) as assessed using RECIST v1.1 | Weeks 24, 38, and 52 |
| Overall Survival | Overall survival (OS) as determined by survival time following first NanoPac injection | Weeks 24, 38, and 52 |
| Change in Tumor Dimensions (Longest Diameter) | Change in longest dimension (cm) as determined by CT imaging compared to baseline (Screening) | Weeks 12, 24, 38, and 52 |
| Fort Wayne |
| Indiana |
| 46845 |
| United States |
| Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599-1350 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type of Lung Cancer | Count of Participants | Participants |
|
|
|
| Secondary | Concentration of Paclitaxel in the Systemic Circulation Post-injection | To characterize the pharmacokinetics of intratumoral NanoPac, plasma samples were taken on days of NanoPac injection prior to injection and at 1, 2, and 4 hours after NanoPac injection, as well as at all other study visits up through Week 24. Plasma paclitaxel concentrations are reported in pg/mL. | Of the 18 subjects enrolled, one subject in the "NanoPac 15 mg/ml - One Injection" arm was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments but was included in the outcome measure of concentration of paclitaxel in the systemic circulation post-injection. The remaining two subjects in the "NanoPac 15 mg/ml - One Injection" arm discontinued from the study prior to Week 12. | Posted | Mean | Standard Deviation | pg/mL | Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24 |
|
|
|
| Secondary | Progression Free Survival (PFS) | Progression free survival (PFS) as assessed using RECIST v1.1 | Of the 18 subjects enrolled, one subject was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments i.e. PFS. | Posted | Count of Participants | Participants | Weeks 24, 38, and 52 |
|
|
|
| Secondary | Overall Survival | Overall survival (OS) as determined by survival time following first NanoPac injection | Of the 18 subjects enrolled, one subject was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments i.e. overall survival. | Posted | Count of Participants | Participants | Weeks 24, 38, and 52 |
|
|
|
| Secondary | Change in Tumor Dimensions (Longest Diameter) | Change in longest dimension (cm) as determined by CT imaging compared to baseline (Screening) | Of the 18 subjects enrolled, one subject in the "NanoPac 15 mg/ml - One Injection" arm was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments, i.e. change in tumor dimensions (longest diameter). The remaining two subjects in the "NanoPac 15 mg/ml - One Injection" arm discontinued from the study prior to Week 12. | Posted | Mean | Standard Deviation | cm | Weeks 12, 24, 38, and 52 |
|
|
|
| 1 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | NanoPac 15 mg/mL - Two Injections | Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received two of the optional three NanoPac injections. | 3 | 5 | 3 | 5 | 5 | 5 |
| EG002 | NanoPac 15 mg/mL - Three Injections | Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received all three of the optional NanoPac injections. | 6 | 10 | 7 | 10 | 10 | 10 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Acute interstitial pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pulseless electrical activity | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Fluid overload | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
|
| Adrenal mass | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatic lesion | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia pseudomonal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Systemic candida | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Clubbing | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Mental status changed | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
Not provided
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D043823 |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| Day 1 - 1 Hr Post-Injection |
|
|
| Day 1 - 2 Hr Post-Injection |
|
|
| Day 1 - 4 Hr Post-Injection |
|
|
| Week 1 |
|
|
| Week 2 |
|
|
| Week 4 - Pre-Injection |
|
|
| Week 5 |
|
|
| Week 6 |
|
|
| Week 8 - Pre-Injection |
|
|
| Week 9 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
| Week 18 |
|
|
| Week 24 |
|
|
| Censored |
|
| Week 38 |
|
| Week 52 |
|
| Censored |
|
| Week 38 |
|
| Week 52 |
|
| Week 24 - Change from Baseline |
|
|
| Week 38 - Change from Baseline |
|
|
| Week 52 - Change from Baseline |
|
|