Trial Outcomes & Findings for A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood (NCT NCT06504862)
NCT ID: NCT06504862
Last Updated: 2026-01-09
Results Overview
Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Within 3 hours (h) before dabigatran-etexilate administration (R only), within 3 h prior to zongertinib administration (T only), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48 h after dabigatran-etexilate administration (R and T).
Results posted on
2026-01-09
Participant Flow
This was a non-randomised, open-label, 2-period fixed-sequence crossover trial in healthy male participants to compare the test treatments (T: zongertinib and dabigatran-etexilate in part 1; zongertinib, rosuvastatin, metformin, furosemide in part 2) to the reference treatments (R: dabigatran-etexilate in part 1; rosuvastatin, metformin, furosemide in part 2).
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not included in the trial if any of the entry criteria were violated.
Participant milestones
| Measure |
Part 1: Dabigatran-etexilate (R), Then Zongertinib and Dabigatran-etexilate (T)
Participants were administered a 150 milligram (mg) dabigatran-etexilate hard capsule orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R). After a wash-out period, participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
Part 2: Drug Cocktail (R), Then Zongertinib and Drug Cocktail (T)
Participants were administered a cocktail consisting of a 10 mg rosuvastatin film-coated tablet, a 10 mg metformin oral solution, and a 1 mg furosemide oral solution with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R). In period 2, from Day -9 to Day 3, participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally every day. On Day 1, participants were also administered a cocktail consisting of a 10 mg rosuvastatin film-coated tablet, a 10 mg metformin oral solution, and a 1 mg furosemide oral solution (Test treatment, T). Every medication was administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Period 1, reference treatment (R)
STARTED
|
16
|
16
|
|
Period 1, reference treatment (R)
COMPLETED
|
16
|
16
|
|
Period 1, reference treatment (R)
NOT COMPLETED
|
0
|
0
|
|
Transition period
STARTED
|
16
|
16
|
|
Transition period
COMPLETED
|
15
|
16
|
|
Transition period
NOT COMPLETED
|
1
|
0
|
|
Period 2, test treatment (T)
STARTED
|
15
|
16
|
|
Period 2, test treatment (T)
COMPLETED
|
15
|
16
|
|
Period 2, test treatment (T)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Dabigatran-etexilate (R), Then Zongertinib and Dabigatran-etexilate (T)
Participants were administered a 150 milligram (mg) dabigatran-etexilate hard capsule orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R). After a wash-out period, participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
Part 2: Drug Cocktail (R), Then Zongertinib and Drug Cocktail (T)
Participants were administered a cocktail consisting of a 10 mg rosuvastatin film-coated tablet, a 10 mg metformin oral solution, and a 1 mg furosemide oral solution with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R). In period 2, from Day -9 to Day 3, participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally every day. On Day 1, participants were also administered a cocktail consisting of a 10 mg rosuvastatin film-coated tablet, a 10 mg metformin oral solution, and a 1 mg furosemide oral solution (Test treatment, T). Every medication was administered with 240 mL of water after an overnight fast of at least 10 hours.
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|---|---|---|
|
Transition period
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood
Baseline characteristics by cohort
| Measure |
Part 1: Dabigatran-etexilate (R), Then Zongertinib and Dabigatran-etexilate (T)
n=16 Participants
Participants were administered a 150 milligram (mg) dabigatran-etexilate hard capsule orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R). After a wash-out period, participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
Part 2: Drug Cocktail (R), Then Zongertinib and Drug Cocktail (T)
n=16 Participants
Participants were administered a cocktail consisting of a 10 mg rosuvastatin film-coated tablet, a 10 mg metformin oral solution, and a 1 mg furosemide oral solution with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R). In period 2, from Day -9 to Day 3, participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally every day. On Day 1, participants were also administered a cocktail consisting of a 10 mg rosuvastatin film-coated tablet, a 10 mg metformin oral solution, and a 1 mg furosemide oral solution (Test treatment, T). Every medication was administered with 240 mL of water after an overnight fast of at least 10 hours.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 Years
STANDARD_DEVIATION 9.4 • n=8 Participants
|
37.8 Years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
36.9 Years
STANDARD_DEVIATION 10.2 • n=15 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=8 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=8 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=8 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before dabigatran-etexilate administration (R only), within 3 h prior to zongertinib administration (T only), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48 h after dabigatran-etexilate administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 1: all part 1 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=15 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve of Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
725.25 hour*nanogram/milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.12
|
971.67 hour*nanogram/milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.12
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before dabigatran-etexilate administration (R only), within 3 h prior to zongertinib administration (T only), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48 h after dabigatran-etexilate administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 1: all part 1 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Maximum measured concentration of dabigatran in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=15 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 1: Maximum Measured Concentration of Dabigatran in Plasma (Cmax)
|
89.01 nanogram/milliliter (ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.13
|
110.53 nanogram/milliliter (ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.13
|
PRIMARY outcome
Timeframe: Within 3 h prior to drug cocktail administration (R), within 15 minutes prior to drug cocktail and zongertinib administration (T), and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h after drug cocktail administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 2: all part 2 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=16 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
102.98 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.10
|
237.15 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.10
|
PRIMARY outcome
Timeframe: Within 3 h prior to drug cocktail administration (R), within 15 minutes prior to drug cocktail and zongertinib administration (T), and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h after drug cocktail administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 2: all part 2 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Maximum measured concentration of rosuvastatin in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=16 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 2: Maximum Measured Concentration of Rosuvastatin in Plasma (Cmax)
|
8.87 nanomole/liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.12
|
26.75 nanomole/liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.12
|
PRIMARY outcome
Timeframe: Within 3 h prior to drug cocktail administration (R), within 15 minutes prior to drug cocktail and zongertinib administration (T), and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h after drug cocktail administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 2: all part 2 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=16 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
1355.69 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.04
|
1125.52 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.04
|
PRIMARY outcome
Timeframe: Within 3 h prior to drug cocktail administration (R), within 15 minutes prior to drug cocktail and zongertinib administration (T), and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h after drug cocktail administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 2: all part 2 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Maximum measured concentration of metforminin in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=16 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 2: Maximum Measured Concentration of Metforminin in Plasma (Cmax)
|
230.25 nanomole/liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.06
|
174.00 nanomole/liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.06
|
PRIMARY outcome
Timeframe: Within 3 h prior to drug cocktail administration (R), within 15 minutes prior to drug cocktail and zongertinib administration (T), and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h after drug cocktail administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 2: all part 2 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of furosemide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=16 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
172.84 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.07
|
238.43 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.07
|
PRIMARY outcome
Timeframe: Within 3 h prior to drug cocktail administration (R), within 15 minutes prior to drug cocktail and zongertinib administration (T), and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h after drug cocktail administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 2: all part 2 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Maximum measured concentration of furosemide in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=16 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 2: Maximum Measured Concentration of Furosemide in Plasma (Cmax)
|
75.73 nanomole/liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.11
|
113.45 nanomole/liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.11
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before dabigatran-etexilate administration (R only), within 3 h prior to zongertinib administration (T only), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48 h after dabigatran-etexilate administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 1: all part 1 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=15 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve of Dabigatran in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
700.45 hour*nanogram/milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.12
|
942.02 hour*nanogram/milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.13
|
SECONDARY outcome
Timeframe: Within 3 h prior to drug cocktail administration (R), within 15 minutes prior to drug cocktail and zongertinib administration (T), and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h after drug cocktail administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 2: all part 2 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=16 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
93.10 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.10
|
231.53 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.10
|
SECONDARY outcome
Timeframe: Within 3 h prior to drug cocktail administration (R), within 15 minutes prior to drug cocktail and zongertinib administration (T), and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h after drug cocktail administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 2: all part 2 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=16 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
1343.93 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.04
|
1113.21 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.04
|
SECONDARY outcome
Timeframe: Within 3 h prior to drug cocktail administration (R), within 15 minutes prior to drug cocktail and zongertinib administration (T), and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h after drug cocktail administration (R and T).Population: Pharmacokinetic parameter analysis set (PKS) restricted to part 2: all part 2 participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of furosemide in in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Dabigatran-etexilate (R)
n=16 Participants
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Zongertinib and dabigatran-etexilate (T)
n=16 Participants
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of Furosemide in in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
164.01 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.07
|
235.33 hour*nanomole/liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.07
|
Adverse Events
Part 1: Dabigatran-etexilate (R)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Zongertinib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Zongertinib and Dabigatran-etexilate (T)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: Drug Cocktail (R)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: Zongertinib
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2: Zongertinib and Drug Cocktail (T)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Dabigatran-etexilate (R)
n=16 participants at risk
Participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Part 1: Zongertinib
n=15 participants at risk
Participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 2.
|
Part 1: Zongertinib and Dabigatran-etexilate (T)
n=15 participants at risk
On Day 1 of period 2, after zongertinib administration, participants were administered a 150 mg dabigatran-etexilate hard capsule orally with 240 mL of water after an overnight fast of at least 10 hours (Test treatment, T).
|
Part 2: Drug Cocktail (R)
n=16 participants at risk
Participants were administered a cocktail consisting of a 10 mg rosuvastatin film-coated tablet, a 10 mg metformin oral solution, and a 1 mg furosemide oral solution with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R).
|
Part 2: Zongertinib
n=16 participants at risk
In period 2, from Day -9 to Day -1, participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally every day.
|
Part 2: Zongertinib and Drug Cocktail (T)
n=16 participants at risk
Participants were administered a cocktail consisting of a 10 mg rosuvastatin film-coated tablet, a 10 mg metformin oral solution, and a 1 mg furosemide oral solution on Day 1 of period 2. On the same day, and up to Day 3, participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally every day (Test treatment, T).
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
18.8%
3/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.7%
1/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
12.5%
2/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Chills
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.7%
1/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
12.5%
2/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
18.8%
3/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.7%
1/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
12.5%
2/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Vascular disorders
Haematoma
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
6.7%
1/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Vascular disorders
Phlebitis
|
6.2%
1/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/16 • All adverse events occurring after 1st drug administration within treatment-specific time frames after end of administration, OR until next treatment administration, were assigned to treatment. The time frames for each treatment are: 3 days (dabigatran-etexilate), 6 days (cocktail), 14 days (zongertinib, zongertinib and dabigatran-etexilate, zongertinib and cocktail). All-cause mortality time frame: from drug administration until end of study, up to 30 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER