Trial Outcomes & Findings for G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer (NCT NCT03455829)

Last Updated: 2023-05-06

Results Overview

The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including: * Grade 4 neutropenia * ≥ Grade 3 neutropenic infection/febrile neutropenia * Grade 4 thrombocytopenia * ≥ Grade 3 thrombocytopenia with bleeding * ≥ Grade 3 nonhematologic toxicity (additional criteria for nausea, vomiting, diarrhea, or fatigue: lasting \> 5 days with maximal medical management) * Liver function test abnormalities meeting Hy's Law criteria (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] ≥ 3 × upper limit of normal \[ULN\] and total bilirubin ≥ 2 × ULN).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Cycle 1 Day -16 to Cycle 1 Day 28

Results posted on

2023-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Overall Study STARTED	7	6	4	7	6
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	7	6	4	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Overall Study Death	2	3	2	4	2
Overall Study Study terminated and patients did not have progressive disease or died	5	3	2	2	3
Overall Study Disease progression	0	0	0	1	1

Baseline Characteristics

G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD n=7 Participants Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD n=6 Participants Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID n=7 Participants Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID n=6 Participants Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Total n=30 Participants Total of all reporting groups
Age, Continuous	62.71 years STANDARD_DEVIATION 11.265 • n=99 Participants	62.67 years STANDARD_DEVIATION 8.779 • n=107 Participants	62.75 years STANDARD_DEVIATION 7.805 • n=206 Participants	61.43 years STANDARD_DEVIATION 15.757 • n=7 Participants	66.17 years STANDARD_DEVIATION 3.764 • n=31 Participants	63.10 years STANDARD_DEVIATION 10.118 • n=30 Participants
Sex: Female, Male Female	6 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants	4 Participants n=31 Participants	21 Participants n=30 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	3 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	2 Participants n=31 Participants	9 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	4 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	6 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants	6 Participants n=31 Participants	23 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	3 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants	4 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants	1 Participants n=31 Participants	3 Participants n=30 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	5 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants	4 Participants n=31 Participants	15 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	0 Participants n=31 Participants	8 Participants n=30 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day -16 to Cycle 1 Day 28

Population: Safety analysis set: including all enrolled patients who were administered at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD n=7 Participants Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD n=6 Participants Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID n=7 Participants Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID n=6 Participants Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Dose Limiting Toxicity	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 36 months

Population: Full Analysis Set: All enrolled patients who were administered at least one dose of continuous daily G1T38.

Median time (months) and 95% CI from date of first dose of study drug/randomization until date of documented disease progression or death due to any cause. Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines for tumor assessments were used to determine progression. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD n=7 Participants Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD n=6 Participants Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID n=6 Participants Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID n=6 Participants Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Progression Free Survival (PFS)	19.3 months Interval 2.0 to The upper confidence limit for the median was not estimable, as the upper confidence limits for the survivor function lies above 0.5.	6.0 months Interval 1.8 to The upper confidence limit for the median was not estimable, as the upper confidence limits for the survivor function lies above 0.5.	1.4 months Interval 0.7 to The upper confidence limit for the median was not estimable, as the upper confidence limits for the survivor function lies above 0.5.	7.2 months Interval 1.6 to The upper confidence limit for the median was not estimable, as the upper confidence limits for the survivor function lies above 0.5.	12.9 months Interval 3.6 to The upper confidence limit for the median was not estimable, as the upper confidence limits for the survivor function lies above 0.5.

SECONDARY outcome

Timeframe: 21 months

Population: The response evaluable analysis set includes all patients who received study drug, had a measurable lesion (target lesions) at the baseline tumor assessment, and either (i) had at least 1 post-baseline tumor assessment, or (ii) did not have a post-baseline tumor assessment but had clinical progression as noted by the investigator, or died due to disease progression before their first post-baseline tumor scan.

The percentage of patients who fall into each category of Best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. When no imaging/measurement is done, the patient is not evaluable (NE); and if only a subset of lesion measurements are made, usually the case is also considered NE.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD n=6 Participants Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD n=6 Participants Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID n=7 Participants Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID n=5 Participants Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Best Overall Tumor Response Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Tumor Response Partial Response (PR)	2 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Best Overall Tumor Response Stable Disease (SD)	2 Participants	4 Participants	1 Participants	3 Participants	0 Participants
Best Overall Tumor Response Progressive Disease (PD)	1 Participants	1 Participants	3 Participants	2 Participants	1 Participants
Best Overall Tumor Response Not Evaluable (NE)	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Part 1, Cycle 1 Day -16 to Day -2.

Population: The analysis population included only those patients that received G1T38 on a once daily schedule, that is Cohorts 1-3. Pharmacokinetic data for Cohorts 4 and 5 were not collected due to the twice daily dosing schedule implemented, per recommendation of the Safety Monitoring Committee, for these 2 cohorts.

The observed peak plasma concentration determined from the plasma concentration versus time data.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD n=7 Participants Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Pharmacokinetics of G1T38 and Metabolite G1T30: Maximum Plasma Concentration (Cmax) G1T38 Cycle 1 Day -16	27.229 ng/mL Standard Deviation 8.936	33.375 ng/mL Standard Deviation 12.212	43.850 ng/mL Standard Deviation 21.942	—	—
Pharmacokinetics of G1T38 and Metabolite G1T30: Maximum Plasma Concentration (Cmax) G1T38 Cycle 1 Day -2	17.257 ng/mL Standard Deviation 1.471	26.400 ng/mL Standard Deviation 2.689	42.700 ng/mL Standard Deviation 25.107	—	—
Pharmacokinetics of G1T38 and Metabolite G1T30: Maximum Plasma Concentration (Cmax) Metabolite G1T30 Cycle 1 Day -16	3.080 ng/mL Standard Deviation 1.301	3.568 ng/mL Standard Deviation 0.633	4.220 ng/mL Standard Deviation 1.717	—	—
Pharmacokinetics of G1T38 and Metabolite G1T30: Maximum Plasma Concentration (Cmax) Metabolite G1T30 Cycle 1 Day -2	2.736 ng/mL Standard Deviation 0.764	3.853 ng/mL Standard Deviation 1.146	5.970 ng/mL Standard Deviation 4.369	—	—

SECONDARY outcome

Timeframe: Part 1, Cycle 1 Day -16 to Day -2.

Area under the concentration-time curve from time zero extrapolated to infinity using the linear-up log-down trapezoidal rule.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD n=7 Participants Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Pharmacokinetics of G1T38 and Metabolite G1T30: Area Under Curve - Plasma Concentration (AUC) Infinity G1T38 Cycle 1 Day -16	319.6 h*ng/mL Standard Deviation 107	391.0 h*ng/mL Standard Deviation 85.6	715.6 h*ng/mL Standard Deviation 359	—	—
Pharmacokinetics of G1T38 and Metabolite G1T30: Area Under Curve - Plasma Concentration (AUC) Infinity G1T38 Cycle 1 Day -2	277.4 h*ng/mL Standard Deviation 63.2	390.0 h*ng/mL Standard Deviation 91.0	802.3 h*ng/mL Standard Deviation 519	—	—
Pharmacokinetics of G1T38 and Metabolite G1T30: Area Under Curve - Plasma Concentration (AUC) Infinity Metabolite G1T30 Cycle 1 Day -16	28.443 h*ng/mL Standard Deviation 17.175	30.853 h*ng/mL Standard Deviation 10.577	53.971 h*ng/mL Standard Deviation 23.638	—	—
Pharmacokinetics of G1T38 and Metabolite G1T30: Area Under Curve - Plasma Concentration (AUC) Infinity Metabolite G1T30 Cycle 1 Day -2	30.110 h*ng/mL Standard Deviation 11.255	44.745 h*ng/mL Standard Deviation 13.929	80.145 h*ng/mL Standard Deviation 66.239	—	—

SECONDARY outcome

Timeframe: Part 1, Cycle 1 Day -16 to Day -2.

Terminal half-life, defined as 0.693 divided by the terminal phase rate constant by λz , determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD n=7 Participants Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Pharmacokinetics of G1T38 and Metabolite G1T30: Plasma: Terminal Half Life (T1/2) G1T38 Cycle 1 Day -16	13.83 hour Standard Deviation 1.95	16.30 hour Standard Deviation 4.36	15.59 hour Standard Deviation 2.12	—	—
Pharmacokinetics of G1T38 and Metabolite G1T30: Plasma: Terminal Half Life (T1/2) G1T38 Cycle 1 Day -2	13.59 hour Standard Deviation 2.88	12.61 hour Standard Deviation 1.71	13.93 hour Standard Deviation 2.14	—	—
Pharmacokinetics of G1T38 and Metabolite G1T30: Plasma: Terminal Half Life (T1/2) Metabolite G1T30 Cycle 1 Day -16	11.771 hour Standard Deviation 7.248	12.238 hour Standard Deviation 8.072	22.614 hour Standard Deviation 3.297	—	—
Pharmacokinetics of G1T38 and Metabolite G1T30: Plasma: Terminal Half Life (T1/2) Metabolite G1T30 Cycle 1 Day -2	13.722 hour Standard Deviation 8.025	18.220 hour Standard Deviation 2.027	18.582 hour Standard Deviation 2.977	—	—

SECONDARY outcome

Timeframe: Part 1, Cycle 1 Day -16 to Day -2.

Volume of distribution in the terminal elimination phase, calculated as: Vz/F = (CL/F)/λz

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD n=7 Participants Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD n=4 Participants Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Pharmacokinetics of G1T38: Plasma - Volume of Distribution G1T38 Cycle 1 Day -16	14000 Liter Standard Deviation 6540	18700 Liter Standard Deviation 6910	15900 Liter Standard Deviation 9210	—	—
Pharmacokinetics of G1T38: Plasma - Volume of Distribution G1T38 Cycle 1 Day -2	14900 Liter Standard Deviation 4660	14800 Liter Standard Deviation 5060	12900 Liter Standard Deviation 6490	—	—

Adverse Events

Part 1: Cohort 1 Lerociclib at 200 mg QD

Serious events: 2 serious events

Other events: 7 other events

Deaths: 2 deaths

Part 1: Cohort 2 Lerociclib at 300 mg QD

Serious events: 1 serious events

Other events: 6 other events

Deaths: 3 deaths

Part 1: Cohort 3 Lerociclib at 400 mg QD

Serious events: 1 serious events

Other events: 4 other events

Deaths: 2 deaths

Part 1: Cohort 4 Lerociclib at 150 mg BID

Serious events: 0 serious events

Other events: 7 other events

Deaths: 4 deaths

Part 1: Cohort 5 Lerociclib at 200 mg BID

Serious events: 2 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD n=7 participants at risk Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD n=6 participants at risk Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD n=4 participants at risk Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID n=7 participants at risk Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID n=6 participants at risk Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Infections and infestations COVID-19 pneumonia	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Sepsis	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Nervous system disorders Ischaemic stroke	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.

Other adverse events

Other adverse events
Measure	Part 1: Cohort 1 Lerociclib at 200 mg QD n=7 participants at risk Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 2 Lerociclib at 300 mg QD n=6 participants at risk Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 3 Lerociclib at 400 mg QD n=4 participants at risk Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 4 Lerociclib at 150 mg BID n=7 participants at risk Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally	Part 1: Cohort 5 Lerociclib at 200 mg BID n=6 participants at risk Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Blood and lymphatic system disorders Anaemia	71.4% 5/7 • Number of events 34 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	33.3% 2/6 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 2/4 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 5 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Blood and lymphatic system disorders Leukopenia	57.1% 4/7 • Number of events 35 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	33.3% 2/6 • Number of events 7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Blood and lymphatic system disorders Neutropenia	57.1% 4/7 • Number of events 22 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 3/6 • Number of events 7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	28.6% 2/7 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Blood and lymphatic system disorders Lymphopenia	42.9% 3/7 • Number of events 13 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Blood and lymphatic system disorders Thrombocytopenia	42.9% 3/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 3/6 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Diarrhoea	71.4% 5/7 • Number of events 18 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	100.0% 6/6 • Number of events 13 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	100.0% 4/4 • Number of events 10 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	85.7% 6/7 • Number of events 6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	100.0% 6/6 • Number of events 11 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Nausea	71.4% 5/7 • Number of events 10 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	83.3% 5/6 • Number of events 7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	75.0% 3/4 • Number of events 6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 3/6 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Vomiting	71.4% 5/7 • Number of events 7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	66.7% 4/6 • Number of events 5 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 2/4 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	33.3% 2/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Abdominal pain	42.9% 3/7 • Number of events 7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Constipation	28.6% 2/7 • Number of events 5 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Stomatitis	28.6% 2/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Dry mouth	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Toothache	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Abdominal discomfort	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Abdominal distension	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Abdominal pain upper	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Anal incontinence	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Gastritis	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Glossodynia	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Proctalgia	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Retching	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Gastrointestinal disorders Tongue coated	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Neutrophil count decreased	71.4% 5/7 • Number of events 15 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 5 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 2/4 • Number of events 16 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	28.6% 2/7 • Number of events 7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Lymphocyte count decreased	42.9% 3/7 • Number of events 8 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Transaminases increased	57.1% 4/7 • Number of events 8 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Blood alkaline phosphatase increased	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	28.6% 2/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Platelet count decreased	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	33.3% 2/6 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations White blood cell count decreased	14.3% 1/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Blood lactate dehydrogenase increased	28.6% 2/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Weight decreased	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Blood creatinine increased	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Investigations Electrocardiogram QT prolonged	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Hyperglycaemia	57.1% 4/7 • Number of events 23 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Decreased appetite	42.9% 3/7 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	33.3% 2/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 2/4 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Hyponatraemia	42.9% 3/7 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	28.6% 2/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Hypocalcaemia	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Hyperkalaemia	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Hyperphosphataemia	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Hypophosphataemia	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Metabolism and nutrition disorders Malnutrition	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 2/7 • Number of events 5 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 2/4 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	33.3% 2/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	42.9% 3/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 2/4 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 3/6 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 2/4 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Nasal dryness	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Urinary tract infection	28.6% 2/7 • Number of events 6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 2/4 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Upper respiratory tract infection	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	33.3% 2/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Conjunctivitis	42.9% 3/7 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Skin infection	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Pharyngitis	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Gastroenteritis viral	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Oral candidiasis	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Paronychia	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Pneumonia	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Pyuria	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Rhinitis	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Infections and infestations Viral infection	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
General disorders Fatigue	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	50.0% 3/6 • Number of events 5 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	42.9% 3/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	33.3% 2/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
General disorders Chills	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
General disorders Non-cardiac chest pain	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
General disorders Secretion discharge	14.3% 1/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
General disorders Chest pain	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
General disorders Early satiety	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
General disorders Mucosal inflammation	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
General disorders Oedema peripheral	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
General disorders Influenza like illness	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
General disorders Malaise	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Nervous system disorders Headache	71.4% 5/7 • Number of events 6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Nervous system disorders Dizziness	28.6% 2/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	33.3% 2/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Nervous system disorders Dysgeusia	42.9% 3/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	33.3% 2/6 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Nervous system disorders Altered state of consciousness	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Nervous system disorders Muscle spasticity	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Nervous system disorders Neuropathy peripheral	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Nervous system disorders Presyncope	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	42.9% 3/7 • Number of events 5 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Musculoskeletal and connective tissue disorders Back pain	28.6% 2/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Musculoskeletal and connective tissue disorders Myalgia	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Musculoskeletal and connective tissue disorders Neck pain	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	28.6% 2/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Rash	42.9% 3/7 • Number of events 5 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Dry skin	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Night sweats	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Dermatitis	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Scab	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Skin and subcutaneous tissue disorders Xeroderma	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Renal and urinary disorders Proteinuria	28.6% 2/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Renal and urinary disorders Dysuria	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Renal and urinary disorders Glycosuria	14.3% 1/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Renal and urinary disorders Haematuria	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Renal and urinary disorders Micturition urgency	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Renal and urinary disorders Pollakiuria	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Renal and urinary disorders Renal failure	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Eye disorders Vision blurred	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Eye disorders Conjunctival haemorrhage	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Eye disorders Visual impairment	28.6% 2/7 • Number of events 2 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Eye disorders Dry eye	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Eye disorders Eye pain	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Eye disorders Lacrimation increased	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Eye disorders Vitreous detachment	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Vascular disorders Hypertension	28.6% 2/7 • Number of events 4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Vascular disorders Deep vein thrombosis	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Injury, poisoning and procedural complications Fall	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	16.7% 1/6 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Psychiatric disorders Insomnia	42.9% 3/7 • Number of events 3 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	25.0% 1/4 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Cardiac disorders Tachycardia	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Ear and labyrinth disorders Ear pain	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
Hepatobiliary disorders Hepatic steatosis	14.3% 1/7 • Number of events 1 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/4 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/7 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.	0.00% 0/6 • The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month). An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.

Additional Information

Clinical Trial Info.

G1 Therapeutics, Inc.

Phone: 919-213-9835

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place