Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005395-28 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously. The eligible patient population will be patients with advanced solid tumours. At any time during the trial, it will not be permitted to escalate to a dose which does not fulfil the escalation with overdose control (EWOC) criterion
Not provided
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40 mg BI 836880 | Experimental | BI 836880 |
|
| 120 mg BI 836880 | Experimental | BI 836880 |
|
| 360 mg BI 836880 | Experimental | BI 836880 |
|
| 720 mg BI 836880 | Experimental | BI 836880 |
|
| 1000 mg BI 836880 | Experimental | BI 836880 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 836880 | Drug | BI 836880 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being above 0.33 during the MTD evaluation period, defined as 3 weeks after first administration of trial medication (i.e. cycle 1). Patients who did not complete the MTD evaluation period for reasons other than DLT were excluded from the analysis of the primary endpoint. | Up to 3 weeks after the first administration of trial medication. |
| Number of Patients With Dose-limiting Toxicities (DLT) in the Maximum Tolerated Dose (MTD) Period | DTLs are defined as followed:
| Up to 3 weeks after the first administration of trial medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Drug-related Adverse Events Leading to Dose Reduction or Discontinuation During Treatment Period | Number of patients with drug-related adverse events leading to dose reduction or discontinuation during treatment period. | From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INS Curie | Paris | 75248 | France | |||
| Universitätsklinikum Augsburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39402675 | Derived | Keller S, Kunz U, Schmid U, Beusmans J, Buchert M, He M, Jayadeva G, Le Tourneau C, Luedtke D, Niessen HG, Oum'hamed Z, Pleiner S, Wang X, Graeser R. Comprehensive biomarker and modeling approach to support dose finding for BI 836880, a VEGF/Ang-2 inhibitor. J Transl Med. 2024 Oct 14;22(1):934. doi: 10.1186/s12967-024-05612-x. | |
| 36108560 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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.
A non-randomized, open-label, multi-center dose escalation trial to determine the maximum tolerated dose and recommended Phase 2 dose of BI 836880 in patients with advanced or metastatic/refractory solid tumours.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 40 mg BI 836880 | 40 milligrams (mg) BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| FG001 | 120 mg BI 836880 | 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| FG002 | 360 mg BI 836880 | 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| FG003 | 720 mg BI 836880 | 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| FG004 | 1000 mg BI 836880 | 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of trial medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 40 mg BI 836880 | 40 milligrams (mg) BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| 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 | Maximum Tolerated Dose (MTD) | Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being above 0.33 during the MTD evaluation period, defined as 3 weeks after first administration of trial medication (i.e. cycle 1). Patients who did not complete the MTD evaluation period for reasons other than DLT were excluded from the analysis of the primary endpoint. | Dose-finding cohort treated set: All patients enrolled in dose finding and confirmation of MTD cohort of the trial who were documented to have taken at least 1 dose of study medication and were evaluable for the MTD determination. | Posted | Number | Milligram | Up to 3 weeks after the first administration of trial medication. |
|
From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days.
Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 40 mg BI 836880 | 40 milligrams (mg) BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2019 | Sep 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2017 | Sep 11, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Area Under the Serum Concentration-time Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-tz) After the First Dose | Area under the serum concentration-time curve over the time interval from 0 extrapolated to infinity (AUC0-tz) after the first dose. | 5 minutes before start of BI 836880 infusion and immediately after end of infusion (i.e. 1.5 hours (h) after start of infusion) and 2h, 3h, 5h, 8h, 24h, 72h, 168h, 336h and 504h after start of BI 826880 infusion in cycle 1. |
| Terminal Half-life (t_1/2) of BI 836880 | Terminal half-life (t_1/2) of BI 836880. | 5 minutes before start of BI 836880 infusion and immediately after end of infusion (i.e. 1.5 hours (h) after start of infusion) and 2h, 3h, 5h, 8h, 24h, 72h, 168h, 336h and 504h after start of BI 826880 infusion in cycle 1. |
| Augsburg |
| 86156 |
| Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Le Tourneau C, Becker H, Claus R, Elez E, Ricci F, Fritsch R, Silber Y, Hennequin A, Tabernero J, Jayadeva G, Luedtke D, He M, Isambert N. Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors. ESMO Open. 2022 Oct;7(5):100576. doi: 10.1016/j.esmoop.2022.100576. Epub 2022 Sep 13. |
| Other adverse event or clinical progression |
|
| Dose-limiting toxicity |
|
| Progressive Disease |
|
| Adverse Event |
|
| BG001 | 120 mg BI 836880 | 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| BG002 | 360 mg BI 836880 | 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| BG003 | 720 mg BI 836880 | 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| BG004 | 1000 mg BI 836880 | 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of trial medication. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Number of Patients With Dose-limiting Toxicities (DLT) in the Maximum Tolerated Dose (MTD) Period | DTLs are defined as followed:
| Dose-finding cohort treated set: All patients enrolled in dose finding and confirmation of MTD cohort of the trial who were documented to have taken at least 1 dose of study medication and were evaluable for the MTD determination. | Posted | Count of Participants | Participants | Up to 3 weeks after the first administration of trial medication. |
|
|
|
| Secondary | Number of Patients With Drug-related Adverse Events Leading to Dose Reduction or Discontinuation During Treatment Period | Number of patients with drug-related adverse events leading to dose reduction or discontinuation during treatment period. | Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of trial medication. | Posted | Count of Participants | Participants | From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. |
|
|
|
| Secondary | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-tz) After the First Dose | Area under the serum concentration-time curve over the time interval from 0 extrapolated to infinity (AUC0-tz) after the first dose. | Pharmacokinetic (PK) analysis set: All patients who were treated and provided at least 1 observation for at least 1 PK endpoint without an important protocol deviation relevant to PK evaluations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram * hours/ milliliter | 5 minutes before start of BI 836880 infusion and immediately after end of infusion (i.e. 1.5 hours (h) after start of infusion) and 2h, 3h, 5h, 8h, 24h, 72h, 168h, 336h and 504h after start of BI 826880 infusion in cycle 1. |
|
|
|
| Secondary | Terminal Half-life (t_1/2) of BI 836880 | Terminal half-life (t_1/2) of BI 836880. | Pharmacokinetic (PK) analysis set: All patients who were treated and provided at least 1 observation for at least 1 PK endpoint without an important protocol deviation relevant to PK evaluations. Only participants with available data were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | 5 minutes before start of BI 836880 infusion and immediately after end of infusion (i.e. 1.5 hours (h) after start of infusion) and 2h, 3h, 5h, 8h, 24h, 72h, 168h, 336h and 504h after start of BI 826880 infusion in cycle 1. |
|
|
|
| 2 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | 120 mg BI 836880 | 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. | 1 | 2 | 2 | 2 | 2 | 2 |
| EG002 | 360 mg BI 836880 | 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG003 | 720 mg BI 836880 | 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. | 4 | 17 | 6 | 17 | 17 | 17 |
| EG004 | 1000 mg BI 836880 | 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. | 2 | 5 | 5 | 5 | 5 | 5 |
| EG005 | Total BI 836880 | 40/120/360/720 or 1000 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880. | 9 | 29 | 15 | 29 | 29 | 29 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Eyelid haematoma | 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 |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oesophageal 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 pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hernia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Allergy to immunoglobulin therapy | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Oral fungal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Stoma site inflammation | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Stoma site rash | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Electrocardiogram T wave inversion | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hyperkalaemia | 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 |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Trismus | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Dysaesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Mixed anxiety and depressive disorder | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Urinary tract obstruction | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Lymphoedema | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Raynaud's phenomenon | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.