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This study is open to Japanese adults with different types of advanced cancer that are positive for NRAS/KRAS mutations. This is a study in people for whom previous treatment was not successful or no standard treatment exists.
The purpose of this study is to find the highest dose of BI 3011441 that Japanese people with advanced cancer can tolerate. BI 3011441 is a medicine that may turn off a signal by NRAS/KRAS that makes tumours grow.
Participants take BI 3011441 as capsules once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors collect information on any health problems of the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg BI 3011441 | Experimental | The patients were administered 4 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
|
| 6 mg BI 3011441 | Experimental | The patients were administered 6 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
|
| 8 mg BI 3011441 | Experimental | The patients were administered 8 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3011441 | Drug | BI 3011441 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With DLTs in the MTD Evaluation Period | Number of participants with Dose limiting toxicities (DLT) occurring during the first treatment cycle (first 4 weeks). DLT was defined as any of the following adverse events related to the treatment:
| First treatment cycle, the first 28 days following the start of trial medication. |
| Maximum Tolerated Dose (MTD) of BI 3011441 Monotherapy | Maximum tolerated dose (MTD) of BI 3011441 monotherapy. The MTD was defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being equal or above 0.33 (EWOC criterion) during the MTD evaluation period. The analysis of the MTD was based on a Bayesian 2-parameter logistic regression model (BLRM) with overdose control. | First treatment cycle, the first 28 days following the start of trial medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With DLTs During the Entire On-treatment Period | Number of participants with Dose limiting toxicities (DLT) occurring during the first treatment cycle (first 4 weeks). DLT was defined as any of the following adverse events related to the treatment:
|
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Inclusion Criteria:
Further inclusion criteria apply.
Exclusion Criteria:
Previous anticancer chemotherapy within 3 weeks of the first administration of trial drug. Previous anticancer hormonal treatment or anticancer immunotherapy within 2 weeks of the first administration of trial drugs.
Radiotherapy within 4 weeks prior to first administration of BI 3011441 except as follows
Major surgery within 4 weeks prior to start of treatment or scheduled during the projected course of the trial
Previous treatment with a Rat sarcoma (RAS), Mitogen-activated protein kinase (MAPK) targeting agent
Previous treatment with any investigational agent(s) or targeted treatment within 4 weeks (28 days) prior to start of trial drug or concurrent participation in another clinical trial with an investigational device or drug.
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the study medications
Patients who have a history or current evidence/risk of retinal vein occlusion (RVO) or retinal pigment epithelial detachment or central serous retinopathy; for example, predisposing factors of RVO or central serous retinopathy include uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes.
Patients who have visible retinal pathology that is considered a risk factor for RVO or central serous retinopathy as assessed by ophthalmic examination, such as:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital East | Chiba, Kashiwa | 277-8577 | Japan | |||
| National Cancer Center Hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This study was a phase 1, open-label trial of BI 3011441 monotherapy dose escalation of Maximum tolerated dose (MTD) determination in Japanese patients with Neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS)/Kirsten rat sarcoma viral oncogene homologue (KRAS) mutation positive advanced for whom previous treatment was not successful or no standard treatment exists, unresectable or metastatic refractory solid tumours.
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 mg BI 3011441 | The patients were administered 4 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| FG001 | 6 mg BI 3011441 | The patients were administered 6 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| FG002 | 8 mg BI 3011441 | The patients were administered 8 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 3011441) and were documented to have taken at least 1 dose of open-label trial medication (BI 3011441).
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 mg BI 3011441 | The patients were administered 4 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| 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 Patients With DLTs in the MTD Evaluation Period | Number of participants with Dose limiting toxicities (DLT) occurring during the first treatment cycle (first 4 weeks). DLT was defined as any of the following adverse events related to the treatment:
| Maximum tolerated dose (MTD) evaluation set: Included all patients from the treated set who were not replaced and were evaluable for the MTD evaluation. Only patients with evaluable DLTs are reported. | Posted | Count of Participants | Participants | First treatment cycle, the first 28 days following the start of trial medication. |
|
From first BI 3011441 intake until last BI 3011441 intake + 30 days of Residual effect period (REP), up to 373 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 3011441) and were documented to have taken at least 1 dose of open-label trial medication (BI 3011441).
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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 | 4 mg BI 3011441 | The patients were administered 4 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.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 | Nov 19, 2020 | Sep 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 23, 2022 | Sep 29, 2023 | SAP_001.pdf |
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| From first BI 3011441 intake until last BI 3011441 intake + 30 days of Residual effect period (REP), up to 373 days. |
| Number of Patients With Grade ≥3 Treatment-related Adverse Events | Number of participants with Grade ≥3 treatment-related adverse events is reported. The severity of AEs were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The CTCAE grades are Grade 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE). | From first BI 3011441 intake until last BI 3011441 intake + 30 days of Residual effect period (REP), up to 373 days. |
| Number of Patients With Treatment Related Adverse Events | Number of participants with drug-related adverse events (AEs) analysed as investigator defined drug-related AEs is presented. Medical judgment was used to determine the relationship between the AEs and the study medication, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history. | From first BI 3011441 intake until last BI 3011441 intake + 30 days of Residual effect period (REP), up to 373 days. |
| Area Under the Concentration-time Curve of BI 3011441 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 3011441 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. | Cycle 1: Day 1: Within 5 minutes (min) before and 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h and optionally 12h. and Day 2 : Within 5 minutes (min) before dosing on Day 2. |
| Area Under the Concentration-time Curve of BI 3011441 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point at Steady State (AUC0-tz,ss) | Area under the concentration-time curve of BI 3011441 in plasma over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss) is reported. | Cycle 1: Day 15: Within 5 minutes (min) before drug administration on Day 15, and 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h and optionally 12h. and Day 16 : Within 5 minutes (min) before dosing on Day 16. |
| Maximum Measured Concentration of BI 3011441 in Plasma After First Dose (Cmax) | Maximum measured concentration of BI 3011441 in plasma (Cmax) is reported. | Cycle 1: Day 1: Within 5 minutes (min) before and 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h and optionally 12h. and Day 2 : Within 5 minutes (min) before dosing on Day 2. |
| Maximum Measured Concentration of BI 3011441 in Plasma at Steady State (Cmax,ss) | Maximum measured concentration of BI 3011441 in plasma at steady state (Cmax,ss) is reported. PK samples were collected at the following timepoints. | Cycle 1: Day 15: Within 5 minutes (min) before drug administration on Day 15, and 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h and optionally 12h. and Day 16 : Within 5 minutes (min) before dosing on Day 16. |
| Tokyo, Chuo-ku |
| 104-0045 |
| Japan |
| Japanese Foundation for Cancer Research | Tokyo, Koto-ku | 135-8550 | Japan |
| Clinical disease progression |
|
| Objective disease progression |
|
| BG001 | 6 mg BI 3011441 | The patients were administered 6 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| BG002 | 8 mg BI 3011441 | The patients were administered 8 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| BG003 | 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 |
|
The patients were administered 4 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| OG001 | 6 mg BI 3011441Edit | The patients were administered 6 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| OG002 | 8 mg BI 3011441 | The patients were administered 8 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
|
|
|
| Primary | Maximum Tolerated Dose (MTD) of BI 3011441 Monotherapy | Maximum tolerated dose (MTD) of BI 3011441 monotherapy. The MTD was defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being equal or above 0.33 (EWOC criterion) during the MTD evaluation period. The analysis of the MTD was based on a Bayesian 2-parameter logistic regression model (BLRM) with overdose control. | Maximum tolerated dose (MTD) evaluation set: Included all patients from the treated set who were not replaced and were evaluable for the MTD evaluation. Only evaluable for DLTs patients were considered in the analysis. | Posted | Number | milligram (mg) | First treatment cycle, the first 28 days following the start of trial medication. |
|
|
|
| Secondary | Number of Patients With DLTs During the Entire On-treatment Period | Number of participants with Dose limiting toxicities (DLT) occurring during the first treatment cycle (first 4 weeks). DLT was defined as any of the following adverse events related to the treatment:
| Treated Set (TS): This set included all patients who were dispensed trial medication (BI 3011441) and were documented to have taken at least 1 dose of open-label trial medication (BI 3011441). | Posted | Count of Participants | Participants | From first BI 3011441 intake until last BI 3011441 intake + 30 days of Residual effect period (REP), up to 373 days. |
|
|
|
| Secondary | Number of Patients With Grade ≥3 Treatment-related Adverse Events | Number of participants with Grade ≥3 treatment-related adverse events is reported. The severity of AEs were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The CTCAE grades are Grade 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE). | Treated Set (TS): This set included all patients who were dispensed trial medication (BI 3011441) and were documented to have taken at least 1 dose of open-label trial medication (BI 3011441). | Posted | Count of Participants | Participants | From first BI 3011441 intake until last BI 3011441 intake + 30 days of Residual effect period (REP), up to 373 days. |
|
|
|
| Secondary | Number of Patients With Treatment Related Adverse Events | Number of participants with drug-related adverse events (AEs) analysed as investigator defined drug-related AEs is presented. Medical judgment was used to determine the relationship between the AEs and the study medication, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history. | Treated Set (TS): This set included all patients who were dispensed trial medication (BI 3011441) and were documented to have taken at least 1 dose of open-label trial medication (BI 3011441). | Posted | Count of Participants | Participants | From first BI 3011441 intake until last BI 3011441 intake + 30 days of Residual effect period (REP), up to 373 days. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 3011441 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 3011441 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. | Pharmacokinetic parameter analysis set (PKS): Includes all subjects in the treated set who provided at least one evaluable observation for at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour * nanomol/ milliliter (h*nmol/mL) | Cycle 1: Day 1: Within 5 minutes (min) before and 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h and optionally 12h. and Day 2 : Within 5 minutes (min) before dosing on Day 2. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 3011441 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point at Steady State (AUC0-tz,ss) | Area under the concentration-time curve of BI 3011441 in plasma over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss) is reported. | Pharmacokinetic parameter analysis set (PKS): Includes all subjects in the treated set who provided at least one evaluable observation for at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour * nanomol/ milliliter (h*nmol/mL) | Cycle 1: Day 15: Within 5 minutes (min) before drug administration on Day 15, and 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h and optionally 12h. and Day 16 : Within 5 minutes (min) before dosing on Day 16. |
|
|
|
| Secondary | Maximum Measured Concentration of BI 3011441 in Plasma After First Dose (Cmax) | Maximum measured concentration of BI 3011441 in plasma (Cmax) is reported. | Pharmacokinetic parameter analysis set (PKS): Includes all subjects in the treated set who provided at least one evaluable observation for at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol/ liter (nmol/L) | Cycle 1: Day 1: Within 5 minutes (min) before and 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h and optionally 12h. and Day 2 : Within 5 minutes (min) before dosing on Day 2. |
|
|
|
| Secondary | Maximum Measured Concentration of BI 3011441 in Plasma at Steady State (Cmax,ss) | Maximum measured concentration of BI 3011441 in plasma at steady state (Cmax,ss) is reported. PK samples were collected at the following timepoints. | Pharmacokinetic parameter analysis set (PKS): Includes all subjects in the treated set who provided at least one evaluable observation for at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol/ liter (nmol/L) | Cycle 1: Day 15: Within 5 minutes (min) before drug administration on Day 15, and 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h and optionally 12h. and Day 16 : Within 5 minutes (min) before dosing on Day 16. |
|
|
|
| 1 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | 6 mg BI 3011441 | The patients were administered 6 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. | 0 | 4 | 4 | 4 | 4 | 4 |
| EG002 | 8 mg BI 3011441 | The patients were administered 8 milligram (mg) BI 3011441 soft capsule once daily during 4 weeks with water limited to a maximum of 100 milliliters (mL) per capsules, taken without food, at least 1 hour before a meal or 1 hour after a meal. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. | 0 | 8 | 6 | 8 | 8 | 8 |
| Serous retinal detachment | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Haemoperitoneum | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Retinopathy | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
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| Grade 5 |
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