Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002814-37 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBW 2992 | Experimental | To study BIBW 2992 in association with letrozole in hormonoresistant metastatic breast cancer |
|
| Letrozole | Other | Hormonotherapy for metastatic breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBW 2992 | Drug | BIBW 2992 at high and medium dosages |
| |
| BIBW 2992 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Progression Free Participants After 16 Weeks of Treatment | Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Confirmed Objective Response (OR) | OR was defined as complete response (CR) or partial response (PR) and was assessed according to RECIST criteria regardless of treatment status. | Baseline till progression |
| Number of Participants With Clinical Benefit (CB) |
Not provided
Inclusion criteria:
Diagnosis of disease progression inferior or equal to 6 weeks prior to trial entrydefined as:
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 |
|---|---|---|---|---|---|---|
| 1200.5.3306A Boehringer Ingelheim Investigational Site | Caen | France | ||||
| 1200.5.3304A Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26835225 | Derived | Gunzer K, Joly F, Ferrero JM, Gligorov J, de Mont-Serrat H, Uttenreuther-Fischer M, Pelling K, Wind S, Bousquet G, Misset JL. A phase II study of afatinib, an irreversible ErbB family blocker, added to letrozole in patients with estrogen receptor-positive hormone-refractory metastatic breast cancer progressing on letrozole. Springerplus. 2016 Jan 19;5:45. doi: 10.1186/s40064-015-1601-7. eCollection 2016. |
Not provided
Not provided
According to the protocol the starting dose of Afatinib was 50mg/day. This dose was reduced according to the protocol to first 40mg/day and then to 30mg/day due to skin toxicity.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Afatinib 50 mg With Letrozole | Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. |
| FG001 | Afatinib 40 mg With Letrozole | Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. |
| FG002 | Afatinib 30 mg With Letrozole | Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Afatinib 50 mg With Letrozole | Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. |
| BG001 | Afatinib 40 mg With Letrozole |
| 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 | Percentage of Progression Free Participants After 16 Weeks of Treatment | Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD. | Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. | Posted | Number | 95% Confidence Interval | Percentage of participants | 16 weeks |
|
First administration of trial medication until 28 days after last administration of trial medication
Not provided
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 | Afatinib 50 mg With Letrozole | Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077716 | Afatinib |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
BIBW 2992 at high and medium dosages |
|
| Letrozole | Drug | Letrozole at standard dosage |
|
| Letrozole | Drug | Letrozole at standard dosage |
|
CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status. |
| 16 weeks and 24 weeks |
| Time to RECIST Tumour Reponse | The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria. | Baseline till progression |
| Duration of Confirmed OR | Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival). | First occurence or OR till progression or death |
| Progression-free Survival (PFS) | PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. Progression was assessed according to RECIST criteria. | Baseline till progression, death or data cut-off (04 Jan 2010) |
| Overall Survival (OS) | OS was defined as the time from first treatment to death. | Baseline till progression, death or data cut-off |
| Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss) | AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau at steady state. | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
| Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss) | Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state. | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
| Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57) | Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57. | Day 57 |
| Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85) | Cpre,ss,85 represents the pre-dose concentration of afatinib in plasma at steady state on day 85. | Day 85 |
| Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
| Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss) | AUC0-tau,ss represents the area under the concentration curve of letrozole in plasma over a uniform dosing interval tau at steady state. | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
| Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss) | Cmax,ss represents the maximum measured concentration of letrozole in plasma at steady state. | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
| Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to the maximum concentration of letrozole in plasma at steady state. | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
| Change From Baseline in Ca15.3 | Change from baseline in Ca15.3 tumor marker levels | baseline and day 29 |
| Best Change From Baseline in ECOG Performance Status | Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). Improvement is a decrease in ECOG score from baseline of at least 1. Deterioration is an increase in ECOG score from baseline of at least 1 | baseline till end of treatment |
| Nice |
| France |
| 1200.5.3301A Boehringer Ingelheim Investigational Site | Paris | France |
| 1200.5.3305A Boehringer Ingelheim Investigational Site | Paris | France |
| 1200.5.3302A Boehringer Ingelheim Investigational Site | Saint-Cloud | France |
| Progressive Disease |
|
Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
| BG002 | Afatinib 30 mg With Letrozole | Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
| OG001 | Afatinib 40 mg With Letrozole | Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. |
| OG002 | Afatinib 30 mg With Letrozole | Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. |
|
|
| Secondary | Number of Participants With Confirmed Objective Response (OR) | OR was defined as complete response (CR) or partial response (PR) and was assessed according to RECIST criteria regardless of treatment status. | TS | Posted | Number | Participants | Baseline till progression |
|
|
|
| Secondary | Number of Participants With Clinical Benefit (CB) | CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status. | TS | Posted | Number | Participants | 16 weeks and 24 weeks |
|
|
|
| Secondary | Time to RECIST Tumour Reponse | The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria. | TS. Median time to RECIST tumour response was not calculable as there was no OR observed. | Posted | Median | 95% Confidence Interval | days | Baseline till progression |
|
|
|
| Secondary | Duration of Confirmed OR | Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival). | TS. Median duration of RECIST tumour response was not calculable as there was no OR observed. | Posted | Median | 95% Confidence Interval | days | First occurence or OR till progression or death |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. Progression was assessed according to RECIST criteria. | TS | Posted | Median | 95% Confidence Interval | days | Baseline till progression, death or data cut-off (04 Jan 2010) |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from first treatment to death. | TS. Estimation of median time to death was not feasible, due to the small number of patients who died during the trial. | Posted | Median | 95% Confidence Interval | days | Baseline till progression, death or data cut-off |
|
|
|
| Secondary | Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss) | AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau at steady state. | Data were particularly sparse for the 50 mg starting dose group and were not summarised. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
|
|
|
| Secondary | Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss) | Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state. | Data were particularly sparse for the 50 mg starting dose group and were not summarised. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
|
|
|
| Secondary | Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57) | Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57. | Data were particularly sparse for the 50 mg starting dose group and were not summarised. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 57 |
|
|
|
| Secondary | Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85) | Cpre,ss,85 represents the pre-dose concentration of afatinib in plasma at steady state on day 85. | Data were particularly sparse for the 50 mg starting dose group and were not summarised. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 85 |
|
|
|
| Secondary | Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state | Data were particularly sparse for the 50 mg starting dose group and were not summarised. | Posted | Median | Full Range | hours | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
|
|
|
| Secondary | Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss) | AUC0-tau,ss represents the area under the concentration curve of letrozole in plasma over a uniform dosing interval tau at steady state. | Analysis of all treatment arms combined, as Letrozole dose was the same in all arms. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
|
|
|
| Secondary | Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss) | Cmax,ss represents the maximum measured concentration of letrozole in plasma at steady state. | Analysis of all treatment arms combined, as Letrozole dose was the same in all arms. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
|
|
|
| Secondary | Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to the maximum concentration of letrozole in plasma at steady state. | Analysis of all treatment arms combined, as Letrozole dose was the same in all arms. | Posted | Median | Full Range | hours | 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing |
|
|
|
| Secondary | Change From Baseline in Ca15.3 | Change from baseline in Ca15.3 tumor marker levels | Analysis of all treatment arms combined for tumor marker analysis. | Posted | Median | Full Range | percentage of baseline level | baseline and day 29 |
|
|
|
| Secondary | Best Change From Baseline in ECOG Performance Status | Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). Improvement is a decrease in ECOG score from baseline of at least 1. Deterioration is an increase in ECOG score from baseline of at least 1 | Posted | Number | participants | baseline till end of treatment |
|
|
|
| 1 |
| 7 |
| 7 |
| 7 |
| EG001 | Afatinib 40 mg With Letrozole | Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. | 3 | 13 | 13 | 13 |
| EG002 | Afatinib 30 mg With Letrozole | Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. | 5 | 8 | 8 | 8 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Obstruction | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Post precedural sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (12.1) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eyelid disorder | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eyelid irritation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Catheter site inflammation | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cyst | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Epiduritis | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
|
| Genital burning sensation | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D017437 |
| Skin and Connective Tissue Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
|
| Title | Measurements |
|---|---|
|
| Not done |
|