Trial Outcomes & Findings for Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation (NCT NCT01953913)
NCT ID: NCT01953913
Last Updated: 2019-08-12
Results Overview
Percentage of participants with serious adverse events (SAEs).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
542 participants
Primary outcome timeframe
From first drug administration up to 28 days after last drug administration, up to 1624 days.
Results posted on
2019-08-12
Participant Flow
Participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation(s), who have never been treated with an EGFR-tyrosine kinase inhibitor (TKI) were recruited in the phase IIIb open label, multicentre, single-arm trial.
All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that they (all participants) met all inclusion/exclusion criteria. Participants were not to be entered to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
Afatinib
Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28-day treatment cycle.
|
|---|---|
|
Overall Study
STARTED
|
542
|
|
Overall Study
Treated
|
541
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
542
|
Reasons for withdrawal
| Measure |
Afatinib
Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28-day treatment cycle.
|
|---|---|
|
Overall Study
Disease Progression
|
349
|
|
Overall Study
Worsening of underlying cancer
|
22
|
|
Overall Study
Adverse Event
|
20
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
32
|
|
Overall Study
Other than listed
|
108
|
|
Overall Study
Not Treated
|
1
|
Baseline Characteristics
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
Baseline characteristics by cohort
| Measure |
Afatinib
n=541 Participants
Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28-day treatment cycle.
|
|---|---|
|
Age, Continuous
|
58.3 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
286 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
255 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
537 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
541 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first drug administration up to 28 days after last drug administration, up to 1624 days.Population: Treated set (TS): It included all patients who were dispensed trial medication and documented to take at least one dose of investigational treatment (afatinib).
Percentage of participants with serious adverse events (SAEs).
Outcome measures
| Measure |
Afatinib
n=541 Participants
Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28-day treatment cycle.
|
|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
30.3 Percentage of participants (%)
|
SECONDARY outcome
Timeframe: From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.Population: TS
Time to Symptomatic progression (TTSP) was defined as time from first administration of afatinib to date of first documented clinically significant symptomatic progression that required stopping the anti-cancer treatment according to investigator's assessment. 95% confidence intervals (CIs) for the median was calculated for TTSP using Greenwood' standard error estimate.
Outcome measures
| Measure |
Afatinib
n=541 Participants
Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28-day treatment cycle.
|
|---|---|
|
Time to Symptomatic Progression (TTSP)
|
13.99 Months
Interval 12.91 to 15.93
|
SECONDARY outcome
Timeframe: From first drug administration up to 28 days after last drug administration, up to 1624 days.Population: TS
Percentage of participants with drug-related (afatinib-related) adverse events.
Outcome measures
| Measure |
Afatinib
n=541 Participants
Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28-day treatment cycle.
|
|---|---|
|
Percentage of Participants With Drug-related (Afatinib-related) Adverse Events
|
97.6 Percentage of participants (%)
|
Adverse Events
Afatinib
Serious events: 164 serious events
Other events: 529 other events
Deaths: 46 deaths
Serious adverse events
| Measure |
Afatinib
n=541 participants at risk
Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28- day treatment cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Cardiac disorders
Cardiac arrest
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Cardiac disorders
Cardiac tamponade
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Cardiac disorders
Cardiogenic shock
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Cardiac disorders
Cardiomyopathy
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Cardiac disorders
Myocarditis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Cardiac disorders
Pericardial effusion
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Eye disorders
Cataract
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Ascites
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
10/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Ileus
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Nausea
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Odynophagia
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Proctitis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Stomatitis
|
0.55%
3/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
5/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Chest pain
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Death
|
0.55%
3/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
General physical health deterioration
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Mucosal inflammation
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Non-cardiac chest pain
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Oedema peripheral
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Pain
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Peripheral swelling
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Pyrexia
|
0.55%
3/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Bronchitis
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Cellulitis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Device related infection
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Empyema
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Escherichia sepsis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Gastroenteritis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Lung infection
|
0.55%
3/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Nasopharyngitis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Osteomyelitis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Pneumonia
|
1.3%
7/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Sepsis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Septic shock
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Tuberculosis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Urinary tract infection
|
0.74%
4/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Urosepsis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Viral infection
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Injury, poisoning and procedural complications
Fall
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Investigations
Alanine aminotransferase increased
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Investigations
Aspartate aminotransferase increased
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Investigations
Blood bilirubin increased
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Investigations
Blood creatinine increased
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Investigations
Urine output decreased
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Investigations
Weight decreased
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.55%
3/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.74%
4/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.55%
3/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
3.3%
18/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.5%
8/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.92%
5/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue neoplasm
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Altered state of consciousness
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Cerebral infarction
|
0.92%
5/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Cognitive disorder
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Coma
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Dizziness
|
0.55%
3/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Epilepsy
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Headache
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Hemiparesis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Hydrocephalus
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Lethargy
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Loss of consciousness
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Movement disorder
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Paraplegia
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Seizure
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Speech disorder
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Spinal cord compression
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Syncope
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Psychiatric disorders
Confusional state
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Renal and urinary disorders
Renal impairment
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
15/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.37%
2/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
16/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.92%
5/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
6/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Vascular disorders
Deep vein thrombosis
|
0.55%
3/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Vascular disorders
Hypotension
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Vascular disorders
Hypovolaemic shock
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Vascular disorders
Superior vena cava stenosis
|
0.18%
1/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
Other adverse events
| Measure |
Afatinib
n=541 participants at risk
Participants received Afatinib 40 milligram (mg)/30 mg/20 mg film-coated tablets orally with 250 milliliter (mL) of water, once daily of every 28- day treatment cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.9%
48/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Diarrhoea
|
89.3%
483/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Mouth ulceration
|
26.8%
145/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
43/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
135/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
54/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Asthenia
|
7.0%
38/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Chest pain
|
6.1%
33/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Fatigue
|
5.4%
29/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Mucosal inflammation
|
10.5%
57/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
General disorders
Pyrexia
|
7.9%
43/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Paronychia
|
50.1%
271/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Rhinitis
|
6.8%
37/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
58/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
33/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Investigations
Alanine aminotransferase increased
|
14.2%
77/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Investigations
Aspartate aminotransferase increased
|
12.4%
67/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
36/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Investigations
Weight decreased
|
12.9%
70/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.0%
81/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.0%
38/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.8%
53/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
48/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Dizziness
|
7.0%
38/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Nervous system disorders
Headache
|
6.1%
33/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.4%
132/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.6%
52/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.8%
37/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.9%
32/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
5.9%
32/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.2%
28/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.4%
29/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.7%
47/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
7.6%
41/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.6%
52/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
|
Skin and subcutaneous tissue disorders
Rash
|
70.8%
383/541 • For adverse events: From first drug administration up to 28 days after last drug administration, up to 1624 days. For All-cause Mortality: From first drug administration to database lock date, up to 1771 days.
TS. As per the clinical trial protocol, survival follow-up was not required and was not done routinely.
|
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