Trial Outcomes & Findings for LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy (NCT NCT01856478)
NCT ID: NCT01856478
Last Updated: 2026-01-12
Results Overview
Progression-free survival (PFS) was defined as the time from the date of randomization to the date of disease progression (PD) evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (v1.1). or to the date of death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier curves generated for each group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
340 participants
Primary outcome timeframe
From randomization until disease progression, death, or primary completion date, whichever occurs first. Up to 35 months.
Results posted on
2026-01-12
Participant Flow
Randomized, multicenter, open-label, active-control study with two parallel groups to investigate the efficacy and safety of afatinib versus methotrexate in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Eligible patients were stratified by their Eastern Cooperative Oncology Group (ECOG) performance score and prior use of EGFR-targeted antibody therapy in the R/M. Patients were randomized to either afatinib or methotrexate in a 2:1 ratio.
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.
Participant milestones
| Measure |
Afatinib 40 mg
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
112
|
|
Overall Study
Treated
|
228
|
104
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
228
|
112
|
Reasons for withdrawal
| Measure |
Afatinib 40 mg
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Overall Study
Not treated
|
0
|
8
|
|
Overall Study
Progressive disease per RECIST
|
146
|
49
|
|
Overall Study
Worsening of underlying cancer
|
6
|
2
|
|
Overall Study
Adverse events
|
57
|
30
|
|
Overall Study
Non-compliant with protocol
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Refused to continue trial medication
|
13
|
11
|
|
Overall Study
Other reason than listed
|
4
|
10
|
Baseline Characteristics
LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy
Baseline characteristics by cohort
| Measure |
Afatinib 40 mg
n=228 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=112 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 Years
STANDARD_DEVIATION 9.79 • n=9 Participants
|
56.4 Years
STANDARD_DEVIATION 9.36 • n=6 Participants
|
55.2 Years
STANDARD_DEVIATION 9.67 • n=9 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
48 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=9 Participants
|
99 Participants
n=6 Participants
|
292 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
215 Participants
n=9 Participants
|
107 Participants
n=6 Participants
|
322 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From randomization until disease progression, death, or primary completion date, whichever occurs first. Up to 35 months.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment.
Progression-free survival (PFS) was defined as the time from the date of randomization to the date of disease progression (PD) evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (v1.1). or to the date of death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier curves generated for each group.
Outcome measures
| Measure |
Afatinib 40 mg
n=228 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=112 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Progression Free Survival (PFS)
|
2.86 Months
Interval 2.79 to 3.71
|
2.56 Months
Interval 1.51 to 2.79
|
SECONDARY outcome
Timeframe: From randomization until earliest of disease progression, death, or interim cut-off date (11-Apr-2019). Up to 35 months.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment.
Objective response (OR) defined as the number of patients with best overall response of complete response (CR) or partial response (PR), according to RECIST 1.1. Complete response (CR) is defined as the disappearance of all target lesions and partial response (PR) is defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. Patients who did not show CR or PR were considered non-responders, irrespective of protocol violations or missing data.
Outcome measures
| Measure |
Afatinib 40 mg
n=228 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=112 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Objective Response (OR)
|
64 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From randomization until death. Up to 6 years.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment.
Overall survival (OS) defined as the time from the date of randomization to the date of death, regardless of its cause. OS parameters were calculated based on Kaplan-Meier curves generated for each group.
Outcome measures
| Measure |
Afatinib 40 mg
n=228 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=112 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Overall Survival (OS)
|
6.93 Months
Interval 6.31 to 8.41
|
6.41 Months
Interval 5.16 to 8.38
|
SECONDARY outcome
Timeframe: From randomization until the earliest of deterioration, death, discontinuation with death within 4 weeks, or primary analysis date. Up to 30 months.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Patients without global heath/quality of life scale values were excluded from the analysis.
Time to deterioration in global health status was defined as the time from randomization to the first decrease of 10 points on the global health/quality of life (QoL) scale. Patients with no deterioration (including those with disease progression) were censored at the last available health-related quality of life (HRQoL) assessment. The global health status (global health/QoL scale) was evaluated using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), a 30-item instrument designed to measure quality of life in cancer patients. It is composed of the overall health rating and the quality of life rating. The scale ranges from 0 to 100, where a higher score represents better global health status and quality of life.
Outcome measures
| Measure |
Afatinib 40 mg
n=217 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=104 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Time to Deterioration in Global Health Status
|
4.17 Months
Interval 3.65 to 4.4
|
2.83 Months
Interval 2.63 to 7.75
|
SECONDARY outcome
Timeframe: From randomization until the earliest of deterioration, death, discontinuation with death within 4 weeks, or primary analysis date. Up to 19 months.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Patients without pain scale values were excluded from the analysis.
Time to deterioration in pain symptoms was defined as the time from randomization to the first decrease of 10 points on the pain scale. Patients with no deterioration (including those with disease progression) were censored at their last available health-related quality of life (HRQoL) assessment. The pain scale was evaluated using the pain module of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ-H\&N35), which is designed to measure quality of life in head and neck cancer patients. It is composed of 4 questions, inquiring about pain in the mouth, pain in the jaw, soreness in the mouth, and a painful throat. The scale ranges from 0 to 100, where a higher score represents a higher symptom burden.
Outcome measures
| Measure |
Afatinib 40 mg
n=217 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=104 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Time to Deterioration in Pain Symptoms
|
3.65 Months
Interval 3.02 to 4.4
|
2.96 Months
Interval 2.63 to 8.25
|
SECONDARY outcome
Timeframe: From randomization until the earliest of deterioration, death, discontinuation with death within 4 weeks, or primary analysis date. Up to 19 months.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Patients without swallowing scale values were excluded from the analysis.
Time to deterioration in swallowing was defined as the time from randomization to the first decrease of 10 points on the swallowing scale. Patients with no deterioration (including those with disease progression) were censored at their last available health-related quality of life (HRQoL) assessment. The swallowing scale was evaluated using the swallowing module of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ-H\&N35), which is designed to measure swallowing difficulties in head and neck cancer patients. It is composed of 4 questions, inquiring about problems swallowing liquids, pureed food, solid food, and choking when swallowing. The scale ranges from 0 to 100, where a higher score represents greater difficulty in swallowing.
Outcome measures
| Measure |
Afatinib 40 mg
n=216 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=104 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Time to Deterioration in Swallowing
|
4.11 Months
Interval 2.86 to 4.27
|
3.29 Months
Interval 2.56 to 7.39
|
SECONDARY outcome
Timeframe: Mean change over time is reported up to 12 weeks. Detailed time frame in the endpoint description.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Patients without post-baseline global heath/quality of life scale values were excluded from the analysis.
Change in global health status over time was defined as the mean global health/QoL scale score up to the median follow-up time, describing the average global health status derived from the cumulative change over time, measured by the EORTC QLQ-C30. The EORTC QLQ-C30 is a 30-item questionnaire measuring quality of life in cancer patients (0 to 100, higher scores indicate better health/QoL). A mixed-effects growth curve model with a piecewise linear profile adjusted for baseline ECOG performance score and prior EGFR-targeted antibody use in R/M HNSCC was used. The change over time was calculated by dividing the area under the estimated growth curve (AUC) up to the median follow-up time by the median follow-up time. Timeframe: The model included measures at baseline and at the following timepoints, if available: Week 6, 12, 18, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, individual end of treatment (EOT; up to 36 months), and individual follow-up visit (EOT + 4 weeks, up to 37 months).
Outcome measures
| Measure |
Afatinib 40 mg
n=217 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=105 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Change in Global Health Status Over Time
|
22.9 Units on a scale
Standard Error 3.53
|
15.0 Units on a scale
Standard Error 3.79
|
SECONDARY outcome
Timeframe: Mean change over time is reported up to 12 weeks. Detailed time frame in the endpoint description.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Patients without post-baseline pain scale values were excluded from the analysis.
Change in pain scale score over time was defined as the mean pain scale score up to the median follow-up time, describing the average pain score derived from the cumulative change over time, measured by the EORTC QLQ-H\&N35 pain module. The EORTC QLQ-H\&N35 pain module is a 4-question tool measuring pain in the mouth, jaw, throat, and soreness in the mouth (0 to 100, higher score = greater pain). A longitudinal mixed-effects growth curve model with a piecewise linear profile adjusted for baseline ECOG performance score and prior EGFR-targeted antibody use in R/M HNSCC was used. The change over time was calculated by dividing the area under the estimated growth curve (AUC) up to median follow-up time by the median follow-up time. Timeframe: The model included measures at baseline and at, if available: Week 6, 12, 18, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, individual end of treatment (EOT; up to 36 months), and individual follow-up visit (EOT + 4 weeks, up to 37 months).
Outcome measures
| Measure |
Afatinib 40 mg
n=217 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=105 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Change in Pain Scale Score Over Time
|
7.6 Units on a scale
Standard Error 2.96
|
11.3 Units on a scale
Standard Error 3.39
|
SECONDARY outcome
Timeframe: Mean change over time is reported up to 12 weeks. Detailed time frame in the endpoint description.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Patients without post-baseline swallowing scale values were excluded from the analysis.
Change in swallowing scale score over time was defined as the mean swallowing scale score up to the median follow-up time, describing the average swallowing score derived from the cumulative change over time. It was assessed by EORTC QLQ-H\&N35 swallowing module, a 4-question tool measuring problems swallowing liquids, pureed food, solid food, and choking when swallowing (0 to 100, higher score = greater difficulty swallowing). A longitudinal mixed-effects growth curve model with a piecewise linear profile adjusted for baseline ECOG and prior EGFR-targeted antibody use in R/M HNSCC was used. The change over time was calculated by dividing the area under the estimated growth curve (AUC) up to median follow-up time by the median follow-up time. Timeframe: the model included measures at baseline and at, if available: Week 6, 12, 18, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, individual end of treatment (EOT; up to 36 months), and individual follow-up visit (EOT + 4 weeks, up to 37 months)
Outcome measures
| Measure |
Afatinib 40 mg
n=216 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=105 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Change in Swallowing Scale Scores Over Time
|
10.1 Units on a scale
Standard Error 3.44
|
14.1 Units on a scale
Standard Error 3.85
|
SECONDARY outcome
Timeframe: Up to 37 months.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Only patients with one baseline and one post-baseline results were included in the analysis.
The number of participants with an improvement in pain scale scores is reported. Improvement was defined as a score that increases by at least 10 points (on a 0-100 point scale) from baseline at any time during the study. If a patient did not show improvement, worsening was defined as a 10-point decrease at any time during the study. Patients who neither improve nor worsen were considered stable. The pain scale was assessed using the pain module of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer (EORTC QLQ-H\&N 35). This questionnaire is designed to measure the quality of life in patients with head and neck cancer. It consists of four questions that inquire about pain in the mouth, pain in the jaw, soreness in the mouth, and a painful throat. The scale ranges from 0 to 100, where a higher score indicates a greater symptom burden.
Outcome measures
| Measure |
Afatinib 40 mg
n=191 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=71 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Number of Participants With Improvement in Pain Scale Score
Stable
|
59 Participants
|
28 Participants
|
|
Number of Participants With Improvement in Pain Scale Score
Worsened
|
68 Participants
|
25 Participants
|
|
Number of Participants With Improvement in Pain Scale Score
Improved
|
64 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to 37 months.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Only patients with one baseline and one post-baseline results were included in the analysis.
The number of participants with an improvement in swallowing scale scores is reported. Improvement was defined as a score that increases by at least 10 points (on a 0-100 point scale) from baseline at any time during the study. If a patient did not show improvement, worsening was defined as a 10-point decrease at any time during the study. Patients who neither improve nor worsen were considered stable. The swallowing scale was assessed using the swallowing module of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer (EORTC QLQ-H\&N 35). This questionnaire is designed to measure swallowing difficulties in patients with head and neck cancer. It consists of four questions that inquire about problems swallowing liquids, pureed food, solid food, and choking when swallowing. The scale ranges from 0 to 100, where a higher score indicates greater difficulty in swallowing.
Outcome measures
| Measure |
Afatinib 40 mg
n=190 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=71 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Number of Participants With Improvement in Swallowing Scale Score
Improved
|
65 Participants
|
13 Participants
|
|
Number of Participants With Improvement in Swallowing Scale Score
Stable
|
55 Participants
|
32 Participants
|
|
Number of Participants With Improvement in Swallowing Scale Score
Worsened
|
70 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Up to 37 months.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Only patients with one baseline and one pos-baseline results were included in the analysis.
The number of participants with an improvement in the overall health rate of global health status is reported. Improvement was defined as a score that increases by at least 10 points (on a 0-100 point scale) from baseline at any time during the study. If a patient did not show improvement, worsening was defined as a 10-point decrease at any time during the study. Patients who neither improve nor worsen were considered stable. The global health status (global health/QoL scale) was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), a 30-item instrument designed to measure quality of life in all cancer patients. It consists of the overall health rating and the quality of life rating. The scale ranges from 0 to 100, where a higher score indicates better global health status and quality of life.
Outcome measures
| Measure |
Afatinib 40 mg
n=191 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=71 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Number of Participants With Improvement in Overall Health Rate of the Global Health Status
Stable
|
33 Participants
|
19 Participants
|
|
Number of Participants With Improvement in Overall Health Rate of the Global Health Status
Worsened
|
66 Participants
|
31 Participants
|
|
Number of Participants With Improvement in Overall Health Rate of the Global Health Status
Improved
|
92 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to 37 months.Population: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Only patients with one baseline and one post-baseline results were included in the analysis.
The number of participants with an improvement in the quality of life rating of global health status is reported. Improvement was defined as a score that increases by at least 10 points (on a 0-100 point scale) from baseline at any time during the study. If a patient did not show improvement, worsening was defined as a 10-point decrease at any time during the study. Patients who neither improve nor worsen were considered stable. The global health status (global health/QoL scale) was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), a 30-item instrument designed to measure quality of life in all cancer patients. It consists of the overall health rating and the quality of life rating. The scale ranges from 0 to 100, where a higher score indicates better global health status and quality of life.
Outcome measures
| Measure |
Afatinib 40 mg
n=191 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=71 Participants
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Number of Participants With Improvement in Quality of Life Rate of the Global Health Status
Worsened
|
76 Participants
|
32 Participants
|
|
Number of Participants With Improvement in Quality of Life Rate of the Global Health Status
Improved
|
85 Participants
|
23 Participants
|
|
Number of Participants With Improvement in Quality of Life Rate of the Global Health Status
Stable
|
30 Participants
|
16 Participants
|
Adverse Events
Afatinib 40 mg
Serious events: 90 serious events
Other events: 217 other events
Deaths: 205 deaths
Methotrexate 40 mg
Serious events: 36 serious events
Other events: 89 other events
Deaths: 94 deaths
Serious adverse events
| Measure |
Afatinib 40 mg
n=228 participants at risk
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=104 participants at risk
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
5/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
2.9%
3/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Bone marrow toxicity
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
1.9%
2/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
1.9%
2/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Eye disorders
Eye swelling
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
3.9%
9/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
1.9%
2/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
4/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Asthenia
|
1.3%
3/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
1.9%
2/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Death
|
1.8%
4/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
1.9%
2/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Fatigue
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
General physical health deterioration
|
1.8%
4/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Localised oedema
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
3.8%
4/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Sudden death
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Abscess neck
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
1.3%
3/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Empyema
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Herpes virus infection
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Infection
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Lung infection
|
1.3%
3/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
2.9%
3/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Oral infection
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
3.1%
7/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
5.8%
6/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
1.3%
3/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Skin infection
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Haemoglobin decreased
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Weight decreased
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.8%
4/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
3/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
5/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
5.3%
12/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to neck
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
2.2%
5/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
1.9%
2/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour inflammation
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Coma
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Hemiparesis
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Loss of consciousness
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Seizure
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Status epilepticus
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Psychiatric disorders
Completed suicide
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
8/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
2.9%
3/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
1.9%
2/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.1%
7/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Surgical and medical procedures
Haemorrhage prophylaxis
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Vascular disorders
Circulatory collapse
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Vascular disorders
Shock
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
Other adverse events
| Measure |
Afatinib 40 mg
n=228 participants at risk
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
|
Methotrexate 40 mg
n=104 participants at risk
Patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m\^2) dose which could be escalated to 50 mg/m\^2 and/or reduced to 40 mg/m\^2, 30 mg/m\^2, or 20 mg/m\^2, according to the absence of presence of drug-related adverse events (AEs).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.2%
30/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
18.3%
19/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.44%
1/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
15.4%
16/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
10.6%
11/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
5.8%
6/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
11/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
10.6%
11/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
74.1%
169/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
9.6%
10/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Mouth ulceration
|
12.3%
28/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
5.8%
6/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
9.2%
21/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
9.6%
10/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
19.3%
44/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
10.6%
11/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
26/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
4.8%
5/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Asthenia
|
13.2%
30/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
12.5%
13/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Fatigue
|
8.8%
20/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
14.4%
15/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Mucosal inflammation
|
11.0%
25/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
13.5%
14/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
General disorders
Pyrexia
|
5.7%
13/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
17.3%
18/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Infections and infestations
Paronychia
|
18.4%
42/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
7/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
13.5%
14/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
6/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
10.6%
11/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Blood creatinine increased
|
6.6%
15/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
1.9%
2/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Haemoglobin decreased
|
2.2%
5/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
7.7%
8/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
10.6%
11/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Platelet count decreased
|
0.88%
2/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
6.7%
7/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
Weight decreased
|
19.3%
44/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
15.4%
16/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Investigations
White blood cell count decreased
|
3.1%
7/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
11.5%
12/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.0%
32/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
11.5%
12/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.5%
17/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
3.8%
4/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.6%
15/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
3.8%
4/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
18/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
7.7%
8/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
12.3%
28/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.6%
15/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.96%
1/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
7.5%
17/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
13/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
3.8%
4/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
43.9%
100/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
7.7%
8/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.3%
12/228 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
0.00%
0/104 • All cause- mortality: From randomization until individual end of study. Up to 6 years. Adverse events reporting: From first drug administration until last drug administration, plus residual effect period. Up to approximately 6 years.
All cause-mortality: Randomized Set (RS): all patients who are randomized, regardless of taking investigational treatment. Adverse event reporting: treated set: all randomised patients who were documented to have taken at least one dose of study medication.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER