Trial Outcomes & Findings for A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood (NCT NCT06028464)

NCT ID: NCT06028464

Last Updated: 2025-11-05

Results Overview

Area under the concentration-time curve of Zongertinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). 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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration.
• Results posted on: 2025-11-05

Participant Flow

The trial was an open-label, two-treatment, two-period, fixed-sequence crossover trial in healthy male Participants comparing the test treatment (T) with the reference treatment (R). Treatment R consisted of one single oral dose of 60 mg zongertinib as a film-coated tablet alone. Treatment T consisted of one single oral dose of 60 mg zongertinib as a film-coated tablet with multiple oral doses of carbamazepine, titrated from 200 mg once daily (q.d.) to 400 mg q.d., then to 600 mg q.d.

A total of 16 participants entered the trial after being screened for eligibility, ensuring they met all inclusion and none of the exclusion criteria. They were allocated to the same treatment sequence to receive 2 treatments in a fixed order (R-T). All 16 received the first treatment (R), and 15 received the second (T). One participant did not start the second treatment due to a positive drug test result but completed the follow-up visit and was not considered to have prematurely discontinued.

Participant milestones

Measure	Zongertinib Alone (Reference)/ Zongertinib+Carbamazepine (Test) Zongertinib Alone: In the reference treatment period, participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours. Zongertinib + Carbamazepine: In the test treatment period (Period 2), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form after an overnight fast of at least 10 hours, with 240 milliliters (mL) of water. This followed 18 days of pretreatment with increasing doses of Carbamazepine, starting at 200 mg, then 400 mg, and finally 600 mg, administered once daily as extended-release tablets with 240 mL of water. Additionally, subjects continued to receive 600 mg of Carbamazepine once daily for 6 days following Zongertinib administration.
Period 1: Reference Treatment Period (R) STARTED	16
Period 1: Reference Treatment Period (R) COMPLETED	16
Period 1: Reference Treatment Period (R) NOT COMPLETED	0
Washout STARTED	16
Washout COMPLETED	15
Washout NOT COMPLETED	1
Period 2: Test Treatment Period (T) STARTED	15
Period 2: Test Treatment Period (T) COMPLETED	15
Period 2: Test Treatment Period (T) NOT COMPLETED	0

Reasons for withdrawal

Measure

Zongertinib Alone (Reference)/ Zongertinib+Carbamazepine (Test) Zongertinib Alone: In the reference treatment period, participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours. Zongertinib + Carbamazepine: In the test treatment period (Period 2), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form after an overnight fast of at least 10 hours, with 240 milliliters (mL) of water. This followed 18 days of pretreatment with increasing doses of Carbamazepine, starting at 200 mg, then 400 mg, and finally 600 mg, administered once daily as extended-release tablets with 240 mL of water. Additionally, subjects continued to receive 600 mg of Carbamazepine once daily for 6 days following Zongertinib administration.

Washout Positive drug test.

1

Baseline Characteristics

A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood

Baseline characteristics by cohort

Measure	Zongertinib Alone (Reference)/ Zongertinib+Carbamazepine (Test) n=16 Participants Zongertinib Alone: In the reference treatment period, participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours. Zongertinib + Carbamazepine: In the test treatment period (Period 2), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form after an overnight fast of at least 10 hours, with 240 milliliters (mL) of water. This followed 18 days of pretreatment with increasing doses of Carbamazepine, starting at 200 mg, then 400 mg, and finally 600 mg, administered once daily as extended-release tablets with 240 mL of water. Additionally, subjects continued to receive 600 mg of Carbamazepine once daily for 6 days following Zongertinib administration.
Age, Continuous	41.5 Years STANDARD_DEVIATION 11.0 • n=15 Participants
Sex: Female, Male Female	0 Participants n=15 Participants
Sex: Female, Male Male	16 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	0 Participants n=15 Participants
Race (NIH/OMB) White	16 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants

PRIMARY outcome

Timeframe: One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration.

Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (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.

Area under the concentration-time curve of Zongertinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

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.

Outcome measures

Measure	Zongertinib+Carbamazepine (Test, T) n=15 Participants In the test treatment period (Period 2), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form after an overnight fast of at least 10 hours, with 240 milliliters (mL) of water. This followed 18 days of pretreatment with increasing doses of Carbamazepine, starting at 200 mg, then 400 mg, and finally 600 mg, administered once daily as extended-release tablets with 240 mL of water. Additionally, subjects continued to receive 600 mg of Carbamazepine once daily for 6 days following Zongertinib administration.	Zongertinib Alone (Reference, R) n=16 Participants In the reference treatment period (Period 1), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form following an overnight fast of at least 10 hours, with 240 milliliters (mL) of water.
Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	4500.05 hour * nanomole / liter (h*nmol/L) Standard Error NA Adjusted geometric standard error = 1.06	12334.87 hour * nanomole / liter (h*nmol/L) Standard Error NA Adjusted geometric standard error = 1.06

PRIMARY outcome

Timeframe: One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration.

Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (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.

Maximum measured concentration of Zongertinib in plasma (Cmax). 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.

Outcome measures

Measure	Zongertinib+Carbamazepine (Test, T) n=15 Participants In the test treatment period (Period 2), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form after an overnight fast of at least 10 hours, with 240 milliliters (mL) of water. This followed 18 days of pretreatment with increasing doses of Carbamazepine, starting at 200 mg, then 400 mg, and finally 600 mg, administered once daily as extended-release tablets with 240 mL of water. Additionally, subjects continued to receive 600 mg of Carbamazepine once daily for 6 days following Zongertinib administration.	Zongertinib Alone (Reference, R) n=16 Participants In the reference treatment period (Period 1), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form following an overnight fast of at least 10 hours, with 240 milliliters (mL) of water.
Maximum Measured Concentration of Zongertinib in Plasma (Cmax)	515.84 nanomole / liter (nmol/L) Standard Error NA Adjusted geometric standard error = 1.10	914.01 nanomole / liter (nmol/L) Standard Error NA Adjusted geometric standard error = 1.10

SECONDARY outcome

Timeframe: One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration.

Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (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.

Area under the concentration-time curve of Zongertinib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

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

Outcome measures

Measure	Zongertinib+Carbamazepine (Test, T) n=15 Participants In the test treatment period (Period 2), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form after an overnight fast of at least 10 hours, with 240 milliliters (mL) of water. This followed 18 days of pretreatment with increasing doses of Carbamazepine, starting at 200 mg, then 400 mg, and finally 600 mg, administered once daily as extended-release tablets with 240 mL of water. Additionally, subjects continued to receive 600 mg of Carbamazepine once daily for 6 days following Zongertinib administration.	Zongertinib Alone (Reference, R) n=16 Participants In the reference treatment period (Period 1), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form following an overnight fast of at least 10 hours, with 240 milliliters (mL) of water.
Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	4430.05 hour * nanomole / liter (h*nmol/L) Standard Error NA Adjusted geometric standard error = 1.06	12138.26 hour * nanomole / liter (h*nmol/L) Standard Error NA Adjusted geometric standard error = 1.06

Adverse Events

Zongertinib

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Zongertinib+Carbamazepine Loading

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Carbamazepine Loading

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Zongertinib+Carbamazepine

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	Zongertinib n=16 participants at risk Participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 of Visit 2 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours.	Zongertinib+Carbamazepine Loading n=15 participants at risk Participants took 200 mg of carbamazepine after dinner for 4 days, followed by 400 mg after dinner for 2 days.	Carbamazepine Loading n=15 participants at risk Participants took 400 mg of carbamazepine after dinner for 5 days, followed by 600 mg after dinner for 7 days.	Zongertinib+Carbamazepine n=15 participants at risk Participants took 600 mg of carbamazepine in the evening after dinner for 6 days. They also took a single dose of a 60 mg Zongertinib film-coated tablet in the morning on Day 1 of Visit 3, after an overnight fast of at least 10 hours.
Gastrointestinal disorders Constipation	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	20.0% 3/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Gastrointestinal disorders Dry mouth	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Gastrointestinal disorders Faeces hard	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Gastrointestinal disorders Flatulence	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Gastrointestinal disorders Gingival bleeding	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Gastrointestinal disorders Toothache	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
General disorders Fatigue	6.2% 1/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	20.0% 3/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	26.7% 4/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	20.0% 3/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 1/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Eye disorders Conjunctival haemorrhage	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Eye disorders Eye pain	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Infections and infestations Nasopharyngitis	6.2% 1/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	13.3% 2/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Investigations Alanine aminotransferase increased	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Investigations Body temperature increased	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Investigations Gamma-glutamyltransferase increased	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Nervous system disorders Headache	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Psychiatric disorders Abnormal dreams	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
Psychiatric disorders Initial insomnia	0.00% 0/16 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	0.00% 0/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.	6.7% 1/15 • AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.

Additional Information

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• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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