Trial Outcomes & Findings for Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC (NCT NCT00806819)
NCT ID: NCT00806819
Last Updated: 2017-02-02
Results Overview
Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
718 participants
Primary outcome timeframe
From randomisation until cut-off date 9 July 2012
Results posted on
2017-02-02
Participant Flow
5 patients at one investigator site were excluded from the enrollment count because of site non-compliance.
Participant milestones
| Measure |
Nintedanib Plus Pemetrexed
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Overall Study
STARTED
|
353
|
360
|
|
Overall Study
COMPLETED
|
7
|
2
|
|
Overall Study
NOT COMPLETED
|
346
|
358
|
Reasons for withdrawal
| Measure |
Nintedanib Plus Pemetrexed
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Overall Study
progressive disease (modified RECIST )
|
217
|
216
|
|
Overall Study
Worsening or AE of underlying disease
|
18
|
25
|
|
Overall Study
Other AE
|
38
|
40
|
|
Overall Study
Protocol Violation
|
9
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
32
|
29
|
|
Overall Study
Not treated
|
6
|
3
|
|
Overall Study
Reasons other than stated above
|
25
|
41
|
Baseline Characteristics
Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC
Baseline characteristics by cohort
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Total
n=713 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Gender
Female
|
158 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Gender
Male
|
195 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
403 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomisation until cut-off date 9 July 2012Population: RS
Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Progression Free Survival (PFS) as Assessed by Central Independent Review
|
4.4 months
Interval 2.3 to 9.5
|
3.6 months
Interval 1.4 to 7.5
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: RS
Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Overall Survival (Key Secondary Endpoint)
|
12.0 months
Interval 7.0 to 24.2
|
12.7 months
Interval 5.4 to 24.0
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: RS
Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review
|
4.4 Months
Interval 2.3 to 9.5
|
3.4 Months
Interval 1.4 to 7.5
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: RS
Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator
|
5.3 Months
Interval 2.6 to 9.4
|
4.3 Months
Interval 1.9 to 8.3
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: Randomised Set
Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Objective Tumor Response
Central independent reviewer
|
9.1 % of participants
|
8.3 % of participants
|
|
Objective Tumor Response
Investigator assessment
|
15.0 % of participants
|
13.3 % of participants
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: RS
The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Duration of Confirmed Objective Tumour Response
central independent reviewer (N=32, 30)
|
6.9 Months
Interval 5.1 to 11.3
|
4.4 Months
Interval 3.3 to 8.9
|
|
Duration of Confirmed Objective Tumour Response
Investigator assessment (N=53, 48)
|
6.5 Months
Interval 4.4 to 12.7
|
7.2 Months
Interval 4.2 to 16.2
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: RS
Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Time to Confirmed Objective Tumour Response
Central independent review (N=32, 30)
|
2.6 Months
Interval 1.4 to 4.0
|
2.7 Months
Interval 1.4 to 4.2
|
|
Time to Confirmed Objective Tumour Response
Investigator assessment (N=53, 48)
|
2.6 Months
Interval 1.4 to 3.0
|
2.8 Months
Interval 1.4 to 3.1
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: RS
Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Disease Control
Central independent review (N=215, 192)
|
60.9 % of participants
|
53.3 % of participants
|
|
Disease Control
Investigator assessment (N=233, 217)
|
66.0 % of participants
|
60.3 % of participants
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: RS
The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Duration of Disease Control
Central independent review (N=215, 192)
|
7.4 Months
Interval 4.3 to 11.2
|
6.8 Months
Interval 4.2 to 12.5
|
|
Duration of Disease Control
Investigator assessment (N=233, 217)
|
6.9 Months
Interval 4.4 to 12.5
|
6.8 Months
Interval 4.4 to 11.1
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: RS
Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Change From Baseline in Tumour Size
Central independent review (N=298, 305)
|
-10.10 percentage of change in tumor size in mm
Interval -12.63 to -7.58
|
-7.53 percentage of change in tumor size in mm
Interval -10.03 to -5.04
|
|
Change From Baseline in Tumour Size
Investigator assessment (N=322, 325)
|
-15.60 percentage of change in tumor size in mm
Interval -18.75 to -12.46
|
-11.28 percentage of change in tumor size in mm
Interval -14.42 to -8.15
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: RS
Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Clinical Improvement.
|
7.2 Months
Interval 2.8 to 21.9
|
7.5 Months
Interval 1.8 to 24.2
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 monthsPopulation: RS
QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=353 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=360 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Quality of Life (QoL)
Time to deterioration of cough
|
6.0 Months
Interval 2.2 to 23.6
|
4.3 Months
Interval 1.4 to
As only 43.9% of patients had a deterioration of cough by the cut-off date, the 75th percentile was not estimable.
|
|
Quality of Life (QoL)
Time to deterioration of dyspnoea
|
2.4 Months
Interval 0.9 to 6.4
|
2.0 Months
Interval 0.8 to 5.7
|
|
Quality of Life (QoL)
Time to deterioration of pain
|
2.8 Months
Interval 1.2 to 7.0
|
2.7 Months
Interval 1.1 to 8.0
|
SECONDARY outcome
Timeframe: Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3Population: Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available
Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=188 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=40 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide
Nintedanib BIBF 1120 (N=188, 39)
|
0.0883 ng/mL/mg
Geometric Coefficient of Variation 66.4
|
0.103 ng/mL/mg
Geometric Coefficient of Variation 72.9
|
|
Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide
Nintedanib BIBF 1202 (N=188, 40)
|
0.131 ng/mL/mg
Geometric Coefficient of Variation 123
|
0.151 ng/mL/mg
Geometric Coefficient of Variation 125
|
|
Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide
Nintedanib BIBF 1202 glucuronide (N=184, 39)
|
1.40 ng/mL/mg
Geometric Coefficient of Variation 169
|
1.72 ng/mL/mg
Geometric Coefficient of Variation 185
|
SECONDARY outcome
Timeframe: From the first drug administration until 28 days after the last drug administration, up to 36 monthsPopulation: Treated set uncut - all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received.
Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used. Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint.
Outcome measures
| Measure |
Nintedanib Plus Pemetrexed
n=347 Participants
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=357 Participants
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Incidence and Intensity of Adverse Events
CTCAE grade 1
|
4.9 % of participants
|
9.2 % of participants
|
|
Incidence and Intensity of Adverse Events
CTCAE grade 3
|
46.1 % of participants
|
34.5 % of participants
|
|
Incidence and Intensity of Adverse Events
CTCAE grade 4
|
12.4 % of participants
|
7.8 % of participants
|
|
Incidence and Intensity of Adverse Events
CTCAE grade 5
|
9.8 % of participants
|
12.0 % of participants
|
|
Incidence and Intensity of Adverse Events
CTCAE grade 2
|
22.2 % of participants
|
30.5 % of participants
|
Adverse Events
Nintedanib Plus Pemetrexed
Serious events: 104 serious events
Other events: 320 other events
Deaths: 0 deaths
Placebo Plus Pemetrexed
Serious events: 117 serious events
Other events: 312 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nintedanib Plus Pemetrexed
n=347 participants at risk
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=357 participants at risk
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Respiratory tract infection
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Sepsis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Septic shock
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
5/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
2.2%
8/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
7/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.86%
3/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.86%
3/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Angina unstable
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Atrial fibrillation
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Cardiac arrest
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Cardiac tamponade
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Myocardial infarction
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Pericardial effusion
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Cardiac disorders
Sinus tachycardia
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Ear and labyrinth disorders
Vertigo
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Eye disorders
Glaucoma
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Eye disorders
Retinal detachment
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.86%
3/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Gastritis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Nausea
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Vomiting
|
0.86%
3/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
1.7%
6/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Asthenia
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Chest pain
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Death
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Disease progression
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Fatigue
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
General physical health deterioration
|
1.2%
4/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Mass
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Multi-organ failure
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Oedema
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Oedema peripheral
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Pain
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Performance status decreased
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Pyrexia
|
0.86%
3/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
1.1%
4/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Spinal pain
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Sudden death
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Amoebiasis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Appendicitis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Cellulitis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Infection
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Infectious peritonitis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Liver abscess
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Lobar pneumonia
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Lung abscess
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Lung infection
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Lymphangitis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Oesophageal candidiasis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Pneumonia
|
3.2%
11/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
4.5%
16/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Urinary tract infection
|
0.86%
3/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Injury, poisoning and procedural complications
Chemical injury
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Haemoglobin decreased
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Hepatic enzyme increased
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Liver function test abnormal
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Neutrophil count decreased
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Platelet count decreased
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
White blood cell count decreased
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
6/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
1.1%
4/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
1.1%
4/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
1.1%
4/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Ataxia
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Central nervous system necrosis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Convulsion
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Dizziness
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Grand mal convulsion
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Headache
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Spinal cord compression
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Vocal cord paralysis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Psychiatric disorders
Anxiety
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Psychiatric disorders
Confusional state
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Psychiatric disorders
Mental status changes
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Renal and urinary disorders
Renal failure acute
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Renal and urinary disorders
Renal injury
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.58%
2/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
9/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
3.1%
11/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
4/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
5/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.86%
3/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.86%
3/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
1.1%
4/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
5/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
1.7%
6/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.28%
1/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.56%
2/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Vascular disorders
Hypotension
|
0.00%
0/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.84%
3/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Vascular disorders
Raynaud's phenomenon
|
0.29%
1/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
0.00%
0/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
Other adverse events
| Measure |
Nintedanib Plus Pemetrexed
n=347 participants at risk
Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
Placebo Plus Pemetrexed
n=357 participants at risk
Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.5%
26/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
6.4%
23/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.8%
27/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
5.3%
19/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Eye disorders
Lacrimation increased
|
4.3%
15/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
5.9%
21/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
41/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
7.6%
27/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.6%
16/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
6.2%
22/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Constipation
|
14.4%
50/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
18.2%
65/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Diarrhoea
|
34.0%
118/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
15.1%
54/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Nausea
|
36.3%
126/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
33.1%
118/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Stomatitis
|
7.8%
27/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
5.9%
21/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Gastrointestinal disorders
Vomiting
|
24.2%
84/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
19.0%
68/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Asthenia
|
7.2%
25/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
8.7%
31/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Chest pain
|
8.9%
31/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
8.1%
29/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Fatigue
|
33.4%
116/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
35.6%
127/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Oedema peripheral
|
7.5%
26/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
8.4%
30/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Pain
|
4.9%
17/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
5.9%
21/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
General disorders
Pyrexia
|
10.4%
36/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
11.8%
42/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
21/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
5.6%
20/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
149/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
24.4%
87/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Aspartate aminotransferase increased
|
37.2%
129/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
19.0%
68/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Blood alkaline phosphatase increased
|
9.5%
33/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
3.6%
13/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Haemoglobin decreased
|
11.8%
41/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
12.3%
44/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Neutrophil count decreased
|
21.3%
74/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
13.2%
47/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Platelet count decreased
|
6.6%
23/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
3.6%
13/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
Weight decreased
|
6.6%
23/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
4.2%
15/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Investigations
White blood cell count decreased
|
16.4%
57/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
10.6%
38/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.0%
97/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
24.9%
89/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.9%
24/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
7.8%
28/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
20/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
2.2%
8/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.6%
23/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
3.9%
14/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
37/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
10.1%
36/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.6%
16/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
5.6%
20/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.5%
12/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
7.6%
27/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
18/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
4.5%
16/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Dizziness
|
8.6%
30/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
10.9%
39/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Nervous system disorders
Headache
|
12.7%
44/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
13.2%
47/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Psychiatric disorders
Insomnia
|
8.4%
29/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
10.4%
37/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.9%
55/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
16.8%
60/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.0%
45/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
19.6%
70/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.9%
24/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
3.4%
12/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
8.4%
29/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
8.1%
29/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
26/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
9.2%
33/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.3%
22/347 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
7.8%
28/357 • From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
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