Trial Outcomes & Findings for A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors (NCT NCT01115803)

Last Updated: 2019-02-05

Results Overview

The recommended dose for the Phase 2 (Dose Confirmation Phase) study was determined by safety assessment. Doses were escalated following the assessment for toxicity based on Common Terminology Criteria for Adverse Events (CTCAE v4.0). Any adverse events (AE) that were possibly related to LY2584702 were considered toxicities. The Phase 2 dose of LY2584702 was not determined due to unacceptable toxicities of LY2584702 in combination with erlotinib or everolimus in Phase 1 of the study.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

29 participants

Primary outcome timeframe

Baseline up to 6 cycles of 28 days

Results posted on

2019-02-05

Participant Flow

A 2 phase study, a dose escalation phase and a dose confirmation phase. The dose confirmation phase was not initiated. Participant flow reports those participants who discontinued from study drug. Participants who completed 1 cycle of treatment, had the required assessment or an adverse event (AE) were considered to have completed the study.

Participant milestones

Participant milestones
Measure	Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD 50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD 50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD 50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD 100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Overall Study STARTED	4	5	3	5	3	3	6
Overall Study Received at Least 1 Dose of Study Drug	4	5	3	5	3	3	6
Overall Study COMPLETED	4	5	2	5	3	3	4
Overall Study NOT COMPLETED	0	0	1	0	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	1	0
Overall Study Progressive Disease during Cycle1	0	1

Baseline Characteristics

A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD n=4 Participants 50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD n=5 Participants 50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD n=3 Participants 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD n=5 Participants 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD n=6 Participants 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.	Total n=29 Participants Total of all reporting groups
Age, Continuous	52.8 years STANDARD_DEVIATION 7.97 • n=5 Participants	61.4 years STANDARD_DEVIATION 7.86 • n=7 Participants	52.3 years STANDARD_DEVIATION 11.02 • n=5 Participants	63.0 years STANDARD_DEVIATION 3.39 • n=4 Participants	49.0 years STANDARD_DEVIATION 7.55 • n=21 Participants	47.7 years STANDARD_DEVIATION 16.01 • n=8 Participants	47.5 years STANDARD_DEVIATION 16.17 • n=8 Participants	54.0 years STANDARD_DEVIATION 11.65 • n=24 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	15 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	14 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	26 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants	24 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants
Region of Enrollment United States	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants
Region of Enrollment France	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants	25 Participants n=24 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 cycles of 28 days

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

Outcome measures

Outcome measures
Measure	LY2584702 + Erlotinib n=17 Participants Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.	LY2584702+Everolimus n=12 Participants Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD 50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD 100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Recommended Dose for Phase 2 Studies	NA milligrams (mg) The Phase 2 dose of LY2584702 in combination with erlotinib was not determined.	NA milligrams (mg) The Phase 2 dose of LY2584702 in combination with everolimus was not determined.	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 7 months

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

Clinically significant events were defined as serious adverse events (SAEs) and other non-SAEs regardless of causality. A summary of serious and other non SAEs regardless of causality is located in the Reported Adverse Event module.

Outcome measures

Outcome measures
Measure	LY2584702 + Erlotinib n=4 Participants Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.	LY2584702+Everolimus n=5 Participants Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD n=3 Participants 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD n=5 Participants 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD n=6 Participants 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Clinically Significant Effects (Number of Participants With Adverse Events) SAEs	1 Participants	2 Participants	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants
Clinically Significant Effects (Number of Participants With Adverse Events) Non-SAEs	4 Participants	5 Participants	3 Participants	5 Participants	3 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline to disease progression or death or up to 166 days postbaseline

Population: Zero participants were analyzed as no data collected.

PFS was defined as the time from the date of enrollment to the date of objectively determined progressive disease (PD) or death whichever comes first. Censoring of PFS was defined as participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective assessment; for participants who received subsequent systematic anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, PFS was censored at the date of the last objective progression-free disease assessment prior to post discontinuation of therapy. PFS was not analyzed due to different tumor types and different doses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to disease progression or death or up to 6 cycles of 28 days

Population: All participants who received at least 1 dose of study drug and assessed for RR.

Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	LY2584702 + Erlotinib n=4 Participants Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.	LY2584702+Everolimus n=5 Participants Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD n=2 Participants 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD n=3 Participants 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD n=3 Participants 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Response Rate (RR)]	0 percentage of participants No participants achieved PR or CR; confidence interval could not be determined.	0 percentage of participants No participants achieved PR or CR; confidence interval could not be determined.	0 percentage of participants No participants achieved PR or CR; confidence interval could not be determined.	0 percentage of participants No participants achieved PR or CR; confidence interval could not be determined.	0 percentage of participants No participants achieved PR or CR; confidence interval could not be determined.	0 percentage of participants No participants achieved PR or CR; confidence interval could not be determined.	0 percentage of participants No participants achieved PR or CR; confidence interval could not be determined.

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (C1 D1): predose, 0.5, 1, 2, 3, 5, 8 hours postdose and Cycle 1 Day 8 (C1 D8): predose, 0.5, 1, 2, 3, 5, and 8 hours postdose of 28-day cycle

Population: All participants who received at least 1 dose of study drug and had Cmax values.

Outcome measures

Outcome measures
Measure	LY2584702 + Erlotinib n=4 Participants Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.	LY2584702+Everolimus n=4 Participants Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD n=3 Participants 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD n=5 Participants 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD n=6 Participants 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Pharmacokinetics, Maximum Observed Plasma Concentration (Cmax) of LY2584702 C1 D1, single dose	918.24 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 42.9	999.54 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 68.3	2421.64 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 35.1	1768.59 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 50.3	1192.46 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 31.5	2286.22 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 7.3	1569.24 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 28.6
Pharmacokinetics, Maximum Observed Plasma Concentration (Cmax) of LY2584702 C1 D8, steady state	1125.46 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 64.6	1636.71 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 52.6	2709.61 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 50.7	1967.04 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 24.8	1169.95 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 25.2	2260.71 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 34.8	2109.62 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 44.1

SECONDARY outcome

Timeframe: Cycle 1 Days 1 (C1 D1) and Cycle 1 Day 8 (C1 D8) of 28-day cycle

Population: All participants who received at least 1 dose of study drug and had AUC values.

AUC from time 0 to 8 hours (AUC0-8) and AUC from time 0 to infinity (AUC0-∞).

Outcome measures

Outcome measures
Measure	LY2584702 + Erlotinib n=4 Participants Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.	LY2584702+Everolimus n=4 Participants Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD n=3 Participants 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD n=5 Participants 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD n=6 Participants 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Pharmacokinetics, Area Under the Concentration Time Curve (AUC) AUC0-8, D1, single dose	4436.60 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 50.6	4308.98 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 79.8	8610.54 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 49.4	8091.93 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 47.8	5699.856 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 31.9	11410.18 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 3.9	6097.44 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 15.9
Pharmacokinetics, Area Under the Concentration Time Curve (AUC) AUC0-8, D8, steady state	5395.96 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 70.7	7948.43 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 50.4	15225.08 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 43.0	13959.74 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 45.6	5460.80 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 23.3	11327.33 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 34.7	10527.68 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 44.1
Pharmacokinetics, Area Under the Concentration Time Curve (AUC) AUC0-∞, D1, single dose	8699.54 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 38.0	7627.50 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 37.9	20813.83 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 25.0	16254.07 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 20.3	11386.03 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 34.8	22343.07 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation NA Only 2 participants analyzed	8764.13 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 14.1

SECONDARY outcome

Timeframe: Baseline up to 112 Days

Population: All participants who received at least 1 dose of study drug and assessed for BOR.

BOR was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of LD of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.

Outcome measures

Outcome measures
Measure	LY2584702 + Erlotinib n=4 Participants Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.	LY2584702+Everolimus n=5 Participants Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD n=2 Participants 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD n=3 Participants 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD n=3 Participants 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Best Overall Response (BOR) (CR+PR+SD)]	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of study drug discontinuation

Population: Participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	LY2584702 + Erlotinib n=4 Participants Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.	LY2584702+Everolimus n=5 Participants Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD n=3 Participants 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD n=5 Participants 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD n=6 Participants 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Number of Participants Who Died Due to Progressive Disease Within 30 Days of Study Drug Discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

Adverse Events

Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD n=4 participants at risk 50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for 2 28-day cycles.	Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD n=5 participants at risk 50 mg LY2584702 administered orally twice daily BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD n=3 participants at risk 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD n=5 participants at risk 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD n=3 participants at risk 50 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD n=3 participants at risk 100 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD n=6 participants at risk 50 mg LY2584702 administered orally BID plus 150 mg everolimus administered orally QD for 2 28-day cycles.
Cardiac disorders Pericardial effusion	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Gastritis	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Ileus	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Nausea	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Vomiting	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
General disorders Asthenia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
General disorders Pyrexia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Infections and infestations Peritonitis bacterial	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Investigations International normalised ratio increased	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Nervous system disorders Loss of consciousness	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Renal and urinary disorders Urinary tract obstruction	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.

Other adverse events

Other adverse events
Measure	Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD n=4 participants at risk 50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for 2 28-day cycles.	Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD n=5 participants at risk 50 mg LY2584702 administered orally twice daily BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD n=3 participants at risk 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD n=5 participants at risk 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD n=3 participants at risk 50 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD n=3 participants at risk 100 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD n=6 participants at risk 50 mg LY2584702 administered orally BID plus 150 mg everolimus administered orally QD for 2 28-day cycles.
Gastrointestinal disorders Dysphagia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Flatulence	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Gastritis	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Eye disorders Dry eye	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Eye disorders Eye pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Eye disorders Periorbital oedema	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Eye disorders Visual acuity reduced	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Constipation	50.0% 2/4 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	40.0% 2/5 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Diarrhoea	50.0% 2/4 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	60.0% 3/5 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	80.0% 4/5 • Number of events 6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	50.0% 3/6 • Number of events 4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Gingival pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Nausea	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	60.0% 3/5 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	80.0% 4/5 • Number of events 4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Stomatitis	25.0% 1/4 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	50.0% 3/6 • Number of events 4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	60.0% 3/5 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
General disorders Asthenia	75.0% 3/4 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	60.0% 3/5 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	80.0% 4/5 • Number of events 4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 4/6 • Number of events 4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
General disorders Chills	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
General disorders Fatigue	25.0% 1/4 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
General disorders Hyperthermia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
General disorders Non-cardiac chest pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
General disorders Oedema peripheral	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
General disorders Pyrexia	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Hepatobiliary disorders Cytolytic hepatitis	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Hepatobiliary disorders Gallbladder pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Infections and infestations Folliculitis	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Infections and infestations Herpes zoster	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Infections and infestations Rash pustular	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Infections and infestations Rhinitis	50.0% 2/4 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Infections and infestations Tooth abscess	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Infections and infestations Urinary tract infection	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	100.0% 1/1 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Infections and infestations Vulvovaginitis	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Investigations Blood bilirubin increased	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Investigations Coagulation factor v level decreased	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Investigations Electrocardiogram repolarisation abnormality	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Investigations International normalised ratio increased	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Investigations Weight decreased	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Decreased appetite	50.0% 2/4 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	100.0% 5/5 • Number of events 5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	60.0% 3/5 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	83.3% 5/6 • Number of events 6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Gout	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Nervous system disorders Dysgeusia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Psychiatric disorders Anxiety	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Psychiatric disorders Insomnia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Renal and urinary disorders Cystitis noninfective	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Renal and urinary disorders Dysuria	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Renal and urinary disorders Haematuria	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Renal and urinary disorders Micturition disorder	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Renal and urinary disorders Proteinuria	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Renal and urinary disorders Renal failure	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	60.0% 3/5 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	60.0% 3/5 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Dry skin	50.0% 2/4 • Number of events 3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	40.0% 2/5 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Erythema	50.0% 2/4 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Night sweats	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	20.0% 1/5 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
Skin and subcutaneous tissue disorders Skin exfoliation	25.0% 1/4 • Number of events 1 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/5 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/3 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.	0.00% 0/6 Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	LY2584702 + Erlotinib n=4 Participants Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.	LY2584702+Everolimus n=4 Participants Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.	Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD n=3 Participants 100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD n=5 Participants 75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD n=3 Participants 100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.	Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD n=6 Participants 50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Pharmacokinetics, Area Under the Concentration Time Curve (AUC) AUC0-8, D1, single dose	4436.60 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 50.6	4308.98 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 79.8	8610.54 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 49.4	8091.93 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 47.8	5699.856 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 31.9	11410.18 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 3.9	6097.44 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 15.9
Pharmacokinetics, Area Under the Concentration Time Curve (AUC) AUC0-8, D8, steady state	5395.96 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 70.7	7948.43 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 50.4	15225.08 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 43.0	13959.74 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 45.6	5460.80 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 23.3	11327.33 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 34.7	10527.68 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 44.1
Pharmacokinetics, Area Under the Concentration Time Curve (AUC) AUC0-∞, D1, single dose	8699.54 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 38.0	7627.50 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 37.9	20813.83 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 25.0	16254.07 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 20.3	11386.03 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 34.8	22343.07 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation NA Only 2 participants analyzed	8764.13 nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 14.1