Trial Outcomes & Findings for Study for Participants With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo (NCT NCT00538681)

Last Updated: 2020-11-05

Results Overview

Presented are data that evaluates safety based on toxicity using Common Terminology Criteria for Adverse Events (CTCAE v3.0), SAEs, and discontinuations due to SAEs or other non-serious adverse events (AE's) of study participants. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up

Results posted on

2020-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1- Cohort 1 Cycle 1: 500 milligrams (mg) enzastaurin orally (po) as loading dose on Day 1 and 125 mg orally twice daily (BID) on Days 2 to 28 of 28-day cycle then 500 milligrams per square meter (mg/m²) pemetrexed intravenous (IV) followed by 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 125 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 1- Cohort 2 Cycle 1: 1125 mg enzastaurin po as loading dose on Day 1 of a 28-day cycle and 250 mg po BID on Days 2 to 28 of 28-day cycle, then 500 mg/m2 pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 250 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 2- Enzastaurin Cycle 1: 375 mg enzastaurin po 3 times on Day 1 as a loading dose and 250 mg po BID on Day 2 to 28 of a 28-day cycle, then 500 mg/m² IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycle 2 to 6: 250 mg enzastaurin po BID on Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 2- Placebo Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle. Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle.
Overall Study STARTED	9	4	11	11
Overall Study Received ≥1 Dose of Any Study Drug	9	4	11	11
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	9	4	11	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1- Cohort 1 Cycle 1: 500 milligrams (mg) enzastaurin orally (po) as loading dose on Day 1 and 125 mg orally twice daily (BID) on Days 2 to 28 of 28-day cycle then 500 milligrams per square meter (mg/m²) pemetrexed intravenous (IV) followed by 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 125 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 1- Cohort 2 Cycle 1: 1125 mg enzastaurin po as loading dose on Day 1 of a 28-day cycle and 250 mg po BID on Days 2 to 28 of 28-day cycle, then 500 mg/m2 pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 250 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 2- Enzastaurin Cycle 1: 375 mg enzastaurin po 3 times on Day 1 as a loading dose and 250 mg po BID on Day 2 to 28 of a 28-day cycle, then 500 mg/m² IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycle 2 to 6: 250 mg enzastaurin po BID on Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 2- Placebo Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle. Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle.
Overall Study Progressive Disease	7	0	1	0
Overall Study Sponsor Decision	1	3	8	9
Overall Study Adverse Event	1	1	1	0
Overall Study Death	0	0	1	1
Overall Study Investigator Decision	0	0	0	1

Baseline Characteristics

Study for Participants With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1- Cohort 1 n=9 Participants Cycle 1: 500 mg enzastaurin orally (po) as loading dose on Day 1 and 125 mg orally twice daily (BID) on Days 2 to 28 of 28-day cycle then 500 milligrams per square meter (mg/m²) pemetrexed intravenous (IV) followed by 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 125 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 1- Cohort 2 n=4 Participants Cycle 1: 1125 mg enzastaurin po as loading dose on Day 1 of a 28-day cycle and 250 mg po BID on Days 2 to 28 of 28-day cycle, then 500 mg/m2 pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 250 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 2- Enzastaurin n=11 Participants Cycle 1: 375 mg enzastaurin po 3 times on Day 1 as a loading dose and 250 mg po BID on Day 2 to 28 of a 28-day cycle, then 500 mg/m² IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycle 2 to 6: 250 mg enzastaurin po BID on Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 2- Placebo n=10 Participants Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle. Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle.	Other n=1 Participants 500 mg/m² pemetrexed and 75 mg/m² cisplatin administered intravenously	Total n=35 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 9.32 • n=93 Participants	61.2 years STANDARD_DEVIATION 6.85 • n=4 Participants	58.6 years STANDARD_DEVIATION 9.62 • n=27 Participants	59.5 years STANDARD_DEVIATION 9.39 • n=483 Participants	49.1 years STANDARD_DEVIATION NA • n=36 Participants	58.8 years STANDARD_DEVIATION 8.88 • n=10 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants	6 Participants n=483 Participants	1 Participants n=36 Participants	16 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants	4 Participants n=483 Participants	0 Participants n=36 Participants	19 Participants n=10 Participants
Race/Ethnicity, Customized Caucasian	9 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants	10 Participants n=483 Participants	1 Participants n=36 Participants	35 Participants n=10 Participants
Region of Enrollment Belgium	4 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants	0 Participants n=36 Participants	10 Participants n=10 Participants
Region of Enrollment Poland	0 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants	4 Participants n=483 Participants	1 Participants n=36 Participants	9 Participants n=10 Participants
Region of Enrollment Germany	5 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants	2 Participants n=483 Participants	0 Participants n=36 Participants	16 Participants n=10 Participants
Type of Carcinoma Adenocarcinoma: Lung	7 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants	0 Participants n=36 Participants	15 Participants n=10 Participants
Type of Carcinoma Carcinoma Large Cell: Lung	1 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	2 Participants n=483 Participants	0 Participants n=36 Participants	6 Participants n=10 Participants
Type of Carcinoma Squamous Cell Carcinoma: Lung	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	2 Participants n=10 Participants
Type of Carcinoma Carcinoma Non-Small Cell: Lung	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	3 Participants n=10 Participants
Type of Carcinoma Adenocarcinoma, Bronchioalveolar	0 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants	3 Participants n=483 Participants	1 Participants n=36 Participants	9 Participants n=10 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-Fully Active	1 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants	3 Participants n=483 Participants	0 Participants n=36 Participants	9 Participants n=10 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1-Ambulatory, work of a light or sedentary nature	8 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants	7 Participants n=483 Participants	1 Participants n=36 Participants	26 Participants n=10 Participants

PRIMARY outcome

Timeframe: Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up

Population: All randomized participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Part 1- Cohort 1 n=9 Participants Cycle 1: 500 mg enzastaurin orally (po) as loading dose on Day 1 and 125 mg orally twice daily (BID) on Days 2 to 28 of 28-day cycle then 500 milligrams per square meter (mg/m²) pemetrexed intravenous (IV) followed by 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 125 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 1- Cohort 2 n=4 Participants Cycle 1: 1125 mg enzastaurin po as loading dose on Day 1 of a 28-day cycle and 250 mg po BID on Days 2 to 28 of 28-day cycle, then 500 mg/m2 pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 250 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.
Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation] Discontinued due to AE	1 Participants	1 Participants
Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation] SAEs	5 Participants	0 Participants
Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation] AEs	9 Participants	4 Participants

PRIMARY outcome

Timeframe: Baseline to measured PD up to 5 months

Population: No participant completed a full cycle of therapy and data were not collected for this Outcome Measure.

PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have objective progressive disease (PD), PFS was censored at the date of the last objective progression-free assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression or death, PFS was censored at the date of last objective progression-free assessment prior to the initiation of post discontinuation anticancer therapy. PFS was calculated and analyzed based on an alternative definition of censoring; for each participant who is not known to have died or who have had objective disease progression as of the data cut-off date, PFS was censored at the date of last prior contact. Zero participants were analyzed in this outcome as study was terminated early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up

Population: All randomized participants who received at least 1 dose enzastaurin or placebo.

The safety and toxicity profile for Part 2 was defined as serious adverse events (SAEs) and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module.

Outcome measures

Outcome measures
Measure	Part 1- Cohort 1 n=11 Participants Cycle 1: 500 mg enzastaurin orally (po) as loading dose on Day 1 and 125 mg orally twice daily (BID) on Days 2 to 28 of 28-day cycle then 500 milligrams per square meter (mg/m²) pemetrexed intravenous (IV) followed by 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 125 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 1- Cohort 2 n=10 Participants Cycle 1: 1125 mg enzastaurin po as loading dose on Day 1 of a 28-day cycle and 250 mg po BID on Days 2 to 28 of 28-day cycle, then 500 mg/m2 pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 250 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.
Part 2: To Evaluate the Safety and Toxicity Profile of Study Treatments SAEs	2 Participants	4 Participants
Part 2: To Evaluate the Safety and Toxicity Profile of Study Treatments AEs	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline to measured progressive disease (PD) up to 5 months

Population: No participant completed a full cycle of therapy and data were not collected for this Outcome Measure.

Response rate was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions. Best response was confirmed by a second assessment in ≥28 days. Response rate was defined as the number of participants with best response of CR or PR divided by the total number of treated participants. Zero participants were analyzed in this outcome as study was terminated early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to date of death from any cause up to 5 months

Population: No participant completed a full cycle of therapy and data were not collected for this Outcome Measure.

OS time was defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post discontinuation was equal to the last known alive date in mortality status). Zero participants were analyzed in this outcome as study was terminated early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to measured PD up to 5 months

Population: No participant completed a full cycle of therapy and data were not collected for this Outcome Measure.

DDC and response defined as time from complete response (CR), partial response (PR) or stable disease (SD) to first date of objectively determined progressive disease (PD) or death from any cause using RECIST (v1.0) criteria. CR defined as disappearance of all target lesions. PR defined as having ≥30% decrease in sum of longest diameter (LD) of target lesions. PD defined as having ≥20% increase in the sum of the LD of target lesions. SD defined as small changes not meeting above criteria. Participants not known to have died as of data cut-off date, had no objective PD or were lost to follow-up, DCC was censored at date of last objective progression-free assessment (OPFA). Participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objective PD or death were censored at date of last OPFA prior to initiation of post discontinuation anticancer therapy. Zero participants were analyzed in this outcome as study was terminated early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up

Population: No participant completed a full cycle of therapy and data were not collected for this Outcome Measure.

TWS was measured from the date of study enrollment to the first date of a worsening in any of the 6 Lung Cancer Symptom Scale (LCSS) symptoms (appetite, cough, fatigue, shortness of breath, hemoptysis and pain). Participants marked each symptom on a visual analog scale (VAS) that ranged from 0 millimeter (mm) (as good as it can be/none) to 100 mm (as bad/much as it could be). TWS was also measured individually for each of the 6 symptoms independently and were also measured from the date of enrollment to the first date of worsening in pain. For both measurements, worsening was defined as a 15-mm increase from baseline in the participant-reported score for any symptom. Participants who are not known to have had a worsening TWS were censored at the date of the participant's last LCSS assessment. Zero participants were analyzed in this outcome as study was terminated early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and end of study up to 5 months

Population: No participant completed a full cycle of therapy and data were not collected for this Outcome Measure.

Presented are data that evaluates of biomarkers relevant to the study drug and the disease state of the participant's clinical outcome. Zero participants were analyzed in this outcome as study was terminated early.

Outcome measures

Outcome data not reported

Adverse Events

Part 1- Cohort 1

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 1- Cohort 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2- Enzastaurin

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2- Placebo

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2- Pemetrexed + Cisplatin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1- Cohort 1 n=9 participants at risk Cycle 1: 500 mg Enzastaurin orally as loading dose on Day 1 of a 28-day cycle and 125 mg orally twice daily, plus 500 mg/m2 pemetrexed intravenous (IV) and 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2-6: 125 mg Enzastaurin orally twice daily, with 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 1 of each 21-day cycle.	Part 1- Cohort 2 n=4 participants at risk Cycle 1: 1125 mg Enzastaurin orally as loading dose on Day 1 of a 28-day cycle and 250 mg orally twice daily starting on Day 2, plus 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2-6: 250 mg Enzastaurin orally twice daily, with 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 1 of each 21-day cycle.	Part 2- Enzastaurin n=11 participants at risk Cycle 1: 375 mg Enzastaurin orally 3 times on Day 1 of a 28-day cycle and 250 mg orally twice daily starting on Day 2, plus 500 mg/m² pemetrexed intravenously (IV) and 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycle 2-6: 250 mg Enzastaurin orally twice daily on Days 1 to 21 (21-day cycles) with 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on day 1 of each 21-day cycle.	Part 2- Placebo n=10 participants at risk Cycle 1: Placebo was administered orally 3 times on Day 1 and 2 times a day on Days 2-28 (28-day cycle) plus 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on Day 8 of cycle (28-day cycle). Cycle 2-6: Placebo was administered orally 2 time a day on Days 1 to 21 (21-day cycles) plus 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 2- Pemetrexed + Cisplatin n=1 participants at risk Participant was not randomized to Arm A or Arm B but received 500 mg/m² pemetrexed and 75 mg/m² cisplatin administered intravenously but not randomized
Cardiac disorders Pericardial effusion	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Cardiac disorders Tachyarrhythmia	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Ileus paralytic	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Infections and infestations Appendicitis	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Infections and infestations Candidiasis	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Infections and infestations Lung infection	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations Blood amylase increased	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Renal and urinary disorders Haematuria	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Vascular disorders Venous thrombosis limb	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.

Other adverse events

Other adverse events
Measure	Part 1- Cohort 1 n=9 participants at risk Cycle 1: 500 mg Enzastaurin orally as loading dose on Day 1 of a 28-day cycle and 125 mg orally twice daily, plus 500 mg/m2 pemetrexed intravenous (IV) and 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2-6: 125 mg Enzastaurin orally twice daily, with 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 1 of each 21-day cycle.	Part 1- Cohort 2 n=4 participants at risk Cycle 1: 1125 mg Enzastaurin orally as loading dose on Day 1 of a 28-day cycle and 250 mg orally twice daily starting on Day 2, plus 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2-6: 250 mg Enzastaurin orally twice daily, with 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 1 of each 21-day cycle.	Part 2- Enzastaurin n=11 participants at risk Cycle 1: 375 mg Enzastaurin orally 3 times on Day 1 of a 28-day cycle and 250 mg orally twice daily starting on Day 2, plus 500 mg/m² pemetrexed intravenously (IV) and 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycle 2-6: 250 mg Enzastaurin orally twice daily on Days 1 to 21 (21-day cycles) with 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on day 1 of each 21-day cycle.	Part 2- Placebo n=10 participants at risk Cycle 1: Placebo was administered orally 3 times on Day 1 and 2 times a day on Days 2-28 (28-day cycle) plus 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on Day 8 of cycle (28-day cycle). Cycle 2-6: Placebo was administered orally 2 time a day on Days 1 to 21 (21-day cycles) plus 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle.	Part 2- Pemetrexed + Cisplatin n=1 participants at risk Participant was not randomized to Arm A or Arm B but received 500 mg/m² pemetrexed and 75 mg/m² cisplatin administered intravenously but not randomized
General disorders Chest pain	55.6% 5/9 • Number of events 5 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
General disorders Face oedema	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Blood and lymphatic system disorders Anaemia	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	18.2% 2/11 • Number of events 3 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	100.0% 1/1 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	100.0% 1/1 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Cardiac disorders Cardiac failure	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Ear and labyrinth disorders Deafness	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Ear and labyrinth disorders Tinnitus	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Eye disorders Abnormal sensation in eye	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Eye disorders Dry eye	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Eye disorders Eyelid oedema	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Eye disorders Lacrimation increased	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Eye disorders Photopsia	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Eye disorders Visual disturbance	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	50.0% 2/4 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	20.0% 2/10 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Constipation	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	75.0% 3/4 • Number of events 5 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	27.3% 3/11 • Number of events 3 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Diarrhoea	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Dyspepsia	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Faeces discoloured	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	50.0% 2/4 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Gastritis	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Large intestinal haemorrhage	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Nausea	55.6% 5/9 • Number of events 8 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	75.0% 3/4 • Number of events 11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	27.3% 3/11 • Number of events 5 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	50.0% 5/10 • Number of events 7 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Stomatitis	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	18.2% 2/11 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Gastrointestinal disorders Vomiting	44.4% 4/9 • Number of events 7 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	50.0% 2/4 • Number of events 4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	27.3% 3/11 • Number of events 4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	20.0% 2/10 • Number of events 3 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
General disorders Asthenia	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
General disorders Fatigue	77.8% 7/9 • Number of events 7 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	75.0% 3/4 • Number of events 3 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	27.3% 3/11 • Number of events 3 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
General disorders General physical health deterioration	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
General disorders Local swelling	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
General disorders Mucosal inflammation	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
General disorders Oedema peripheral	66.7% 6/9 • Number of events 7 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
General disorders Pain	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
General disorders Pyrexia	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Infections and infestations Bronchitis	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Infections and infestations Candidiasis	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Infections and infestations Nasopharyngitis	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Infections and infestations Rash pustular	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Infections and infestations Respiratory tract infection	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations Blood creatinine increased	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations Blood glucose increased	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations Blood sodium decreased	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations Haemoglobin	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations Neutrophil count	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations Oxygen saturation decreased	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations Platelet count decreased	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 3 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations Urine colour abnormal	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	50.0% 2/4 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations Weight decreased	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Investigations White blood cell count decreased	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Metabolism and nutrition disorders Anorexia	33.3% 3/9 • Number of events 4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	20.0% 2/10 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Musculoskeletal and connective tissue disorders Arthralgia	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Musculoskeletal and connective tissue disorders Back pain	33.3% 3/9 • Number of events 4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Musculoskeletal and connective tissue disorders Myalgia	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Nervous system disorders Dizziness	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	18.2% 2/11 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Nervous system disorders Hemiparesis	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Nervous system disorders Neuropathy peripheral	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Nervous system disorders Paraesthesia	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Nervous system disorders Polyneuropathy	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	50.0% 2/4 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Psychiatric disorders Anxiety	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Psychiatric disorders Confusional state	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Skin and subcutaneous tissue disorders Alopecia	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	20.0% 2/10 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	100.0% 1/1 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Skin and subcutaneous tissue disorders Dermatitis	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Skin and subcutaneous tissue disorders Night sweats	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	10.0% 1/10 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Vascular disorders Arterial occlusive disease	0.00% 0/9 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	25.0% 1/4 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Vascular disorders Hypertension	11.1% 1/9 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	9.1% 1/11 • Number of events 1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Vascular disorders Phlebitis	22.2% 2/9 • Number of events 2 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/4 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/11 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/10 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.	0.00% 0/1 Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60