Trial Outcomes & Findings for BI 2536 Second Line Monotherapy in SCLC (NCT NCT00412880)

Last Updated: 2022-06-22

Results Overview

Objective tumor response by investigator was assessed for patients who completed at least two courses of BI 2536 treatment. Tumor images from CT (computed tomography) scan and MRI (magnetic resonance imaging) were evaluated using Response evaluation criteria in solid tumors (RECIST) criteria to determine best tumor response. Objective response (OR) was defined as either: complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.

Results posted on

2022-06-22

Participant Flow

This is an open-label Phase II trial to investigate the efficacy, safety, and pharmacokinetics of a single dose of 200 mg i.v. BI 2536 administered every 21 days in patients with sensitive relapse small cell lung cancer using an uncontrolled, Gehan two-stage trial design with an early stopping rule based on patient response.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	BI 2536 200 mg Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Overall Study STARTED	23
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 2536 200 mg Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Overall Study Withdrew, overdose of study treatment	1
Overall Study Consent withdrawn	1
Overall Study Adverse Event	1
Overall Study Progressive disease	20

Baseline Characteristics

BI 2536 Second Line Monotherapy in SCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 2536 200 mg n=23 Participants Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Age, Continuous	60.0 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.

Population: Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536. Four patients were excluded from this endpoint due to not having completed two treatment cycles (21 days each).

Outcome measures

Outcome measures
Measure	BI 2536 200 mg n=19 Participants Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Number of Participants With Objective Tumor Response Complete response	0 Participants
Number of Participants With Objective Tumor Response Partial response	0 Participants

SECONDARY outcome

Timeframe: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.

Population: Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.

Progression free survival (PFS) was defined as the duration of time from start of treatment to time of progression (or death any cause). Patients who did not experience progression or death during the trial were censored at the date of last tumor assessment visit at which the patient was evaluated and did not experience progressive disease. Patients who dropped out before any evaluation of response, radiological, clinical, or pathological, were censored at the start of treatment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	BI 2536 200 mg n=23 Participants Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Progression Free Survival (PFS)	43 days Interval 40.0 to 50.0

SECONDARY outcome

Timeframe: From the start of treatment till death or discontinuation, up to 36 weeks.

Population: Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536..

Overall survival (OS) was reported as number of participants with event. Overall survival is the time from first treatment to death. In case there was no occurrence of death or progression during follow-up, the time was censored. Median survival time was not calculated due to the low number of deaths in the trial.

Outcome measures

Outcome measures
Measure	BI 2536 200 mg n=23 Participants Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Overall Survival	5 Participants

SECONDARY outcome

Timeframe: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.

Population: Analysis of duration of overall response was not conducted, as there were no responders

The duration of overall objective response (OR) was measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death any cause. OR is defined as either: CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of treatment till the last infusion + 21 days, up to 36 weeks.

Population: Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.

Occurrence and intensity of adverse events graded according to common terminology criteria of adverse event (CTCAE) version 3.0.

Outcome measures

Outcome measures
Measure	BI 2536 200 mg n=23 Participants Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Occurrence and Intensity of Adverse Events Graded According to CTCAE CTCAE grade 1	1 Participants
Occurrence and Intensity of Adverse Events Graded According to CTCAE CTCAE grade 2	4 Participants
Occurrence and Intensity of Adverse Events Graded According to CTCAE CTCAE grade 3	8 Participants
Occurrence and Intensity of Adverse Events Graded According to CTCAE CTCAE grade 4	6 Participants
Occurrence and Intensity of Adverse Events Graded According to CTCAE CTCAE grade 5	2 Participants

SECONDARY outcome

Timeframe: From the start of treatment till the last treatment + 21 days, up to 36 weeks.

Population: Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.

Number of Participants with Dose Limiting Toxicity. Dose limiting toxicity was defined as: * drug related CTCAE Grade 3 or greater non-hematological toxicity (excluding untreated nausea, vomiting or diarrhea) * drug related CTCAE Grade 4 neutropenia for 7 or more days or complicated by infection * CTCAE Grade 4 thrombocytopenia.

Outcome measures

Outcome measures
Measure	BI 2536 200 mg n=23 Participants Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Number of Participants With Dose Limiting Toxicity	4 Participants

SECONDARY outcome

Timeframe: From the start of treatment till the last treatment + 21 days, up to 36 weeks.

Population: Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.

Number of participants with an increase in common terminology criteria (CTC) Grade classification for hematological and clinical chemistry laboratory measures. Changes from Baseline in laboratory measures were classified according to CTC Grades 1-4. Results summarizes the number of patients who had a change in laboratory value that represented an increase in CTC Grade classification during the study (based on maximum Grade).

Outcome measures

Outcome measures
Measure	BI 2536 200 mg n=23 Participants Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Lymphocytes · CTC Grade 1	3 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Lymphocytes · CTC Grade 2	4 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Lymphocytes · CTC Grade 3	6 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Lymphocytes · CTC Grade 4	1 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Lymphocytes · no increase in CTC grade	9 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Neutrophil · CTC Grade 1	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Neutrophil · CTC Grade 2	4 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Neutrophil · CTC Grade 3	6 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Neutrophil · CTC Grade 4	11 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Neutrophil · no increase in CTC grade	2 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Aspartate aminotransferase · CTC Grade 1	4 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Aspartate aminotransferase · CTC Grade 2	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Aspartate aminotransferase · CTC Grade 3	2 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Aspartate aminotransferase · CTC Grade 4	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Aspartate aminotransferase · no increase in CTC grade	17 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Alanine aminotransferase · CTC Grade 1	4 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Alanine aminotransferase · CTC Grade 2	1 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Alanine aminotransferase · CTC Grade 3	1 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Alanine aminotransferase · CTC Grade 4	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Alanine aminotransferase · no increase in CTC grade	17 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Haemoglobin · CTC Grade 1	5 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Haemoglobin · CTC Grade 2	9 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Haemoglobin · CTC Grade 3	1 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Haemoglobin · CTC Grade 4	1 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Haemoglobin · no increase in CTC grade	7 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Platelets · CTC Grade 1	10 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Platelets · CTC Grade 2	1 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Platelets · CTC Grade 3	3 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Platelets · CTC Grade 4	1 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Platelets · no increase in CTC grade	8 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures White blood cell count · CTC Grade 1	1 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures White blood cell count · CTC Grade 2	8 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures White blood cell count · CTC Grade 3	11 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures White blood cell count · CTC Grade 4	3 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures White blood cell count · no increase in CTC grade	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Creatinine · CTC Grade 1	1 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Creatinine · CTC Grade 2	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Creatinine · CTC Grade 3	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Creatinine · CTC Grade 4	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Creatinine · no increase in CTC grade	22 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Bilirubin, total · CTC Grade 1	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Bilirubin, total · CTC Grade 2	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Bilirubin, total · CTC Grade 3	2 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Bilirubin, total · CTC Grade 4	0 Participants
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures Bilirubin, total · no increase in CTC grade	21 Participants

Adverse Events

BI 2536 200 mg

Serious events: 5 serious events

Other events: 21 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	BI 2536 200 mg n=23 participants at risk Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Blood and lymphatic system disorders Febrile neutropenia	4.3% 1/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Endocrine disorders Inappropriate antidiuretic hormone secretion	4.3% 1/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Gastrointestinal disorders Pancreatitis	4.3% 1/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
General disorders Disease progression	4.3% 1/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Infections and infestations Sepsis	4.3% 1/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Injury, poisoning and procedural complications Overdose	4.3% 1/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Musculoskeletal and connective tissue disorders Back pain	4.3% 1/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	4.3% 1/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	4.3% 1/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.

Other adverse events

Other adverse events
Measure	BI 2536 200 mg n=23 participants at risk Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Blood and lymphatic system disorders Anaemia	26.1% 6/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Blood and lymphatic system disorders Leukopenia	17.4% 4/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Blood and lymphatic system disorders Neutropenia	47.8% 11/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Blood and lymphatic system disorders Thrombocytopenia	21.7% 5/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Gastrointestinal disorders Constipation	26.1% 6/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Gastrointestinal disorders Diarrhoea	13.0% 3/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Gastrointestinal disorders Nausea	30.4% 7/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Gastrointestinal disorders Stomatitis	13.0% 3/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Gastrointestinal disorders Vomiting	26.1% 6/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
General disorders Fatigue	39.1% 9/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
General disorders Pain	13.0% 3/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
General disorders Pyrexia	8.7% 2/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Infections and infestations Upper respiratory tract infection	8.7% 2/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Investigations White blood cell count decreased	8.7% 2/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Musculoskeletal and connective tissue disorders Arthralgia	17.4% 4/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Musculoskeletal and connective tissue disorders Back pain	17.4% 4/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Nervous system disorders Dizziness	13.0% 3/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Nervous system disorders Headache	8.7% 2/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Psychiatric disorders Hallucination	8.7% 2/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Psychiatric disorders Insomnia	8.7% 2/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Vascular disorders Hypotension	8.7% 2/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
Metabolism and nutrition disorders Anorexia	8.7% 2/23 • Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks. Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.

Additional Information

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