Trial Outcomes & Findings for Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients (NCT NCT01897714)

NCT ID: NCT01897714

Last Updated: 2020-10-23

Results Overview

The best overall disease response on treatment including stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), stable disease (SD) or progressive disease (PD) were evaluated. Starting on completion of Cycle 2, response was assessed according to International Myeloma Working Group (IMWG) criteria based on Investigator's assessment for all patients at every cycle during treatment period. PD was defined as increase of ≥25% from lowest response value in any 1 of the following: serum M-component (absolute increase must be ≥0.5 gram/deciliter) and/or urine M-component (absolute increase must be ≥200 mg/24 hr); development of new bone lesions or soft tissue plasmacytomas or increase in size of existing bone lesions or soft tissue plasmacytomas or development of hypercalcemia that could be attributed solely to plasma cell proliferative disorder. SD was defined as not meeting criteria for CR, VGPR, PR or PD.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 75 participants
• Primary outcome timeframe: Baseline (Cycle 1 Day 1) and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.
• Results posted on: 2020-10-23

Participant Flow

This was an open-label, Phase I/IIa study conducted at 7 study centers in 5 countries in patients with relapsed and/or relapsed-refractory Multiple Myeloma (MM). Overall, 75 patients (23 during Phase I and 52 additional patients during Phase II) were enrolled. The study results are presented until the end of trial (EOT) date of 29 October 2019.

The study was conducted in 2 parts: Phase I (dose escalation) and Phase II (maximum tolerated dose [MTD]). During Phase I, the standard 3 + 3 design was followed with 3 to 6 patients tested at each dose level, depending on the dose limiting toxicity (DLT) observed. During Phase II, patients were treated at the MTD determined in Phase I.

Participant milestones

Measure	Phase I: Melflufen 15 mg + Dexamethasone Patients were treated with 15 milligram (mg) melflufen as intravenous (IV) infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Phase I (Dose Escalation) STARTED	4	7	6	6	0	0
Phase I (Dose Escalation) COMPLETED	1	0	1	0	0	0
Phase I (Dose Escalation) NOT COMPLETED	3	7	5	6	0	0
Phase II (MTD) STARTED	0	0	0	0	45	13
Phase II (MTD) COMPLETED	0	0	0	0	15	2
Phase II (MTD) NOT COMPLETED	0	0	0	0	30	11

Reasons for withdrawal

Measure	Phase I: Melflufen 15 mg + Dexamethasone Patients were treated with 15 milligram (mg) melflufen as intravenous (IV) infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Phase I (Dose Escalation) Disease progression	3	5	1	3	0	0
Phase I (Dose Escalation) Adverse Event	0	1	4	3	0	0
Phase I (Dose Escalation) Other	0	1	0	0	0	0
Phase II (MTD) Withdrawal by Subject	0	0	0	0	0	1
Phase II (MTD) Lost to Follow-up	0	0	0	0	1	0
Phase II (MTD) Death	0	0	0	0	25	10
Phase II (MTD) Study terminated with patient alive	0	0	0	0	1	0
Phase II (MTD) Other	0	0	0	0	3	0

Baseline Characteristics

6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).

Baseline characteristics by cohort

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=4 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=7 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone n=6 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone n=6 Participants Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone n=45 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) n=13 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Total n=81 Participants Total of all reporting groups
Age, Categorical Phase I · <=18 years	0 Participants n=4 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=7 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	—	—	0 Participants n=23 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Age, Categorical Phase I · Between 18 and 65 years	1 Participants n=4 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	3 Participants n=7 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	3 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	2 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	—	—	9 Participants n=23 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Age, Categorical Phase I · >=65 years	3 Participants n=4 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	4 Participants n=7 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	3 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	4 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	—	—	14 Participants n=23 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Age, Categorical Phase II · <=18 years	—	—	—	—	0 Participants n=45 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=13 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=58 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Age, Categorical Phase II · Between 18 and 65 years	—	—	—	—	20 Participants n=45 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	8 Participants n=13 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	28 Participants n=58 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Age, Categorical Phase II · >=65 years	—	—	—	—	25 Participants n=45 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	5 Participants n=13 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	30 Participants n=58 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Sex: Female, Male Phase I · Female	2 Participants n=4 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	4 Participants n=7 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	2 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	3 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	—	—	11 Participants n=23 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Sex: Female, Male Phase I · Male	2 Participants n=4 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	3 Participants n=7 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	4 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	3 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	—	—	12 Participants n=23 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Sex: Female, Male Phase II · Female	—	—	—	—	15 Participants n=45 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	5 Participants n=13 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	20 Participants n=58 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Sex: Female, Male Phase II · Male	—	—	—	—	30 Participants n=45 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	8 Participants n=13 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	38 Participants n=58 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Race/Ethnicity, Customized Phase I · Black or African American	1 Participants n=4 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	1 Participants n=7 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	—	—	2 Participants n=23 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Race/Ethnicity, Customized Phase I · Caucasian	3 Participants n=4 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	6 Participants n=7 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	6 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	6 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	—	—	21 Participants n=23 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Race/Ethnicity, Customized Phase I · Not collected as per local laws	0 Participants n=4 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=7 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	1 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	1 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	—	—	2 Participants n=23 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Race/Ethnicity, Customized Phase II · Black or African American	—	—	—	—	3 Participants n=45 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	3 Participants n=13 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	6 Participants n=58 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Race/Ethnicity, Customized Phase II · Caucasian	—	—	—	—	41 Participants n=45 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	10 Participants n=13 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	51 Participants n=58 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Race/Ethnicity, Customized Phase II · Not collected as per local laws	—	—	—	—	7 Participants n=45 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	1 Participants n=13 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	8 Participants n=58 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Race/Ethnicity, Customized Phase I · Hispanic or Latino	0 Participants n=4 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	1 Participants n=7 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	—	—	1 Participants n=23 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Race/Ethnicity, Customized Phase I · Not Hispanic or Latino	4 Participants n=4 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	6 Participants n=7 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	5 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	5 Participants n=6 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	—	—	20 Participants n=23 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Race/Ethnicity, Customized Phase II · Hispanic or Latino	—	—	—	—	1 Participants n=45 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	0 Participants n=13 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	1 Participants n=58 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
Race/Ethnicity, Customized Phase II · Not Hispanic or Latino	—	—	—	—	37 Participants n=45 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	12 Participants n=13 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).	49 Participants n=58 Participants • 6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).

PRIMARY outcome

Timeframe: Baseline (Cycle 1 Day 1) and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.

Population: For Phase I arms: The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug. For Phase II arms: Modified Intent-to-Treat (mITT) Analysis Set included all patients considered to be valid for Safety Analysis Set and who received at least 1 dose of study drug at the MTD as initial dose.

The best overall disease response on treatment including stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), stable disease (SD) or progressive disease (PD) were evaluated. Starting on completion of Cycle 2, response was assessed according to International Myeloma Working Group (IMWG) criteria based on Investigator's assessment for all patients at every cycle during treatment period. PD was defined as increase of ≥25% from lowest response value in any 1 of the following: serum M-component (absolute increase must be ≥0.5 gram/deciliter) and/or urine M-component (absolute increase must be ≥200 mg/24 hr); development of new bone lesions or soft tissue plasmacytomas or increase in size of existing bone lesions or soft tissue plasmacytomas or development of hypercalcemia that could be attributed solely to plasma cell proliferative disorder. SD was defined as not meeting criteria for CR, VGPR, PR or PD.

Outcome measures

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=4 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=7 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone n=6 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone n=6 Participants Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone n=45 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) n=13 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Percentage of Patients Who Achieved Best Overall Disease Response sCR	0.0 percentage of patients Interval 0.0 to 60.2	0.0 percentage of patients Interval 0.0 to 41.0	0.0 percentage of patients Interval 0.0 to 45.9	0.0 percentage of patients Interval 0.0 to 45.9	0.0 percentage of patients Interval 0.0 to 7.9	0.0 percentage of patients Interval 0.0 to 24.7
Percentage of Patients Who Achieved Best Overall Disease Response CR	0.0 percentage of patients Interval 0.0 to 60.2	0.0 percentage of patients Interval 0.0 to 41.0	0.0 percentage of patients Interval 0.0 to 45.9	0.0 percentage of patients Interval 0.0 to 45.9	0.0 percentage of patients Interval 0.0 to 7.9	0.0 percentage of patients Interval 0.0 to 24.7
Percentage of Patients Who Achieved Best Overall Disease Response VGPR	0.0 percentage of patients Interval 0.0 to 60.2	0.0 percentage of patients Interval 0.0 to 41.0	16.7 percentage of patients Interval 0.4 to 64.1	16.7 percentage of patients Interval 0.4 to 64.1	11.1 percentage of patients Interval 3.7 to 24.1	0.0 percentage of patients Interval 0.0 to 24.7
Percentage of Patients Who Achieved Best Overall Disease Response PR	0.0 percentage of patients Interval 0.0 to 60.2	0.0 percentage of patients Interval 0.0 to 41.0	50.0 percentage of patients Interval 11.8 to 88.2	0.0 percentage of patients Interval 0.0 to 45.9	20.0 percentage of patients Interval 9.6 to 34.6	7.7 percentage of patients Interval 0.2 to 36.0
Percentage of Patients Who Achieved Best Overall Disease Response MR	0.0 percentage of patients Interval 0.0 to 60.2	0.0 percentage of patients Interval 0.0 to 41.0	0.0 percentage of patients Interval 0.0 to 45.9	0.0 percentage of patients Interval 0.0 to 45.9	17.8 percentage of patients Interval 8.0 to 32.1	15.4 percentage of patients Interval 1.9 to 45.4
Percentage of Patients Who Achieved Best Overall Disease Response SD	75.0 percentage of patients Interval 19.4 to 99.4	42.9 percentage of patients Interval 9.9 to 81.6	16.7 percentage of patients Interval 0.4 to 64.1	66.7 percentage of patients Interval 22.3 to 95.7	26.7 percentage of patients Interval 14.6 to 41.9	69.2 percentage of patients Interval 38.6 to 90.9
Percentage of Patients Who Achieved Best Overall Disease Response PD	25.0 percentage of patients Interval 0.6 to 80.6	57.1 percentage of patients Interval 18.4 to 90.1	16.7 percentage of patients Interval 0.4 to 64.1	16.7 percentage of patients Interval 0.4 to 64.1	15.6 percentage of patients Interval 6.5 to 29.5	7.7 percentage of patients Interval 0.2 to 36.0
Percentage of Patients Who Achieved Best Overall Disease Response Missing	0.0 percentage of patients Interval 0.0 to 60.2	0.0 percentage of patients Interval 0.0 to 41.0	0.0 percentage of patients Interval 0.0 to 45.9	0.0 percentage of patients Interval 0.0 to 45.9	8.9 percentage of patients Interval 2.5 to 21.2	0.0 percentage of patients Interval 0.0 to 24.7
Percentage of Patients Who Achieved Best Overall Disease Response sCR + CR	0.0 percentage of patients Interval 0.0 to 60.2	0.0 percentage of patients Interval 0.0 to 41.0	0.0 percentage of patients Interval 0.0 to 45.9	0.0 percentage of patients Interval 0.0 to 45.9	0.0 percentage of patients Interval 0.0 to 7.9	0.0 percentage of patients Interval 0.0 to 24.7
Percentage of Patients Who Achieved Best Overall Disease Response sCR + CR + VGPR	0.0 percentage of patients Interval 0.0 to 60.2	0.0 percentage of patients Interval 0.0 to 41.0	16.7 percentage of patients Interval 0.4 to 64.1	16.7 percentage of patients Interval 0.4 to 64.1	11.1 percentage of patients Interval 3.7 to 24.1	0.0 percentage of patients Interval 0.0 to 24.7

PRIMARY outcome

Timeframe: Baseline and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.

Population: For Phase I arms: The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug. For Phase II arms: The mITT Analysis Set included all patients considered to be valid for the Safety Analysis Set and who received at least 1 dose of study drug at the MTD as the initial dose.

ORR was defined as percentage of patients with an overall response (OR), defined as first occurrence of confirmed disease response including PR or better (i.e, PR, VGPR, CR or sCR). Starting on completion of Cycle 2, response was assessed according to IMWG criteria based on Investigator's assessment for all patients at every cycle during treatment period. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum plus urine M-protein level <100 mg/24hr and >90% decrease in difference between involved and uninvolved free light chain (FLC) levels (only in FLC diseased patients). CR was defined as negative immunofixation on serum and urine, loss of any soft tissue plasmacytomas, <5% plasma cells in bone marrow and normal FLC ratio of 0.26 to 1.65 (only in FLC diseased patients). sCR was defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or 2 to 4 color flow cytometry.

Outcome measures

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=4 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=7 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone n=6 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone n=6 Participants Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone n=45 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) n=13 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Overall Response Rate (ORR)	0.0 percentage of patients Interval 0.0 to 60.2	0.0 percentage of patients Interval 0.0 to 41.0	66.7 percentage of patients Interval 22.3 to 95.7	16.7 percentage of patients Interval 0.4 to 64.1	31.1 percentage of patients Interval 18.2 to 46.6	7.7 percentage of patients Interval 0.2 to 36.0

PRIMARY outcome

Timeframe: Baseline and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.

Population: For Phase I arms: The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug. For Phase II arms: The mITT Analysis Set included all patients considered to be valid for the Safety Analysis Set and who received at least 1 dose of study drug at the MTD as the initial dose.

The CBRR was defined as the percentage of patients with a clinical benefit response (CBR), defined as the first occurrence of confirmed disease response including MR or better (i.e, MR, PR, VGPR, CR, or sCR). Starting on completion of Cycle 2, response was assessed according to the IMWG criteria based on the Investigator's assessment for all patients at every cycle during the treatment period. MR was defined as ≥25% but <49% reduction of serum M-protein and reduction in 24 hour urine M-protein by 50 to 89%, which still exceeds 200 mg/24 hours. In addition to above; if present at baseline, 25 to 49% reduction in the size of soft tissue plasmacytomas is also required. No increase in size or number of lytic bone lesions (development of compression fractures does not exclude response). PR was defined as 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by ≥90% or to <200 mg/24 hour.

Outcome measures

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=4 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=7 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone n=6 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone n=6 Participants Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone n=45 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) n=13 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Clinical Benefit Response Rate (CBRR)	0.0 percentage of patients Interval 0.0 to 60.2	0.0 percentage of patients Interval 0.0 to 41.0	66.7 percentage of patients Interval 22.3 to 95.7	16.7 percentage of patients Interval 0.4 to 64.1	48.9 percentage of patients Interval 33.7 to 64.2	23.1 percentage of patients Interval 5.0 to 53.8

SECONDARY outcome

Timeframe: Baseline and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.

Population: The mITT Analysis Set included all patients considered to be valid for the Safety Analysis Set and who received at least 1 dose of study drug at the MTD as the initial dose. Only patients who had achieved at least PR were evaluated.

The DOR to treatment was defined as time from first response (PR or better) to disease progression or death, or date of last evaluable disease response assessment for those who had not progressed or died. DOR was estimated using Kaplan-Meier statistics.

Outcome measures

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=14 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=1 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Duration of Disease Response (DOR)	8.4 months Interval 4.6 to 11.1	7.2 months The confidence interval could not be determined as only 1 patient was analysed.	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.

Population: The mITT Analysis Set included all patients considered to be valid for the Safety Analysis Set and who received at least 1 dose of study drug at the MTD as the initial dose. Only patients who had achieved OR and CBR were evaluated, for each respective time to response parameter.

Time to first OR was defined as the time from the date of the first dose of study drug (overall reference start date) to the date of the first occurrence of PR or better (first of 2 consecutive assessments-confirmed response). Time to first CBR was defined as the time from the date of the first dose of study drug (overall reference start date) to the date of the first occurrence of MR or better (first of 2 consecutive assessments-confirmed response). Time to disease response was estimated using Kaplan-Meier statistics.

Outcome measures

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=22 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=3 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Time to Disease Response in Patients Who Achieved OR and CBR OR	2.8 months Interval 1.6 to 4.7	6.7 months The confidence interval could not be determined as only 1 patient was analysed.	—	—	—	—
Time to Disease Response in Patients Who Achieved OR and CBR CBR	2.4 months Interval 1.4 to 3.0	2.8 months Interval 2.8 to 6.1	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.

Population: The mITT Analysis Set included all patients considered to be valid for the Safety Analysis Set and who received at least 1 dose of study drug at the MTD as the initial dose.

Time to disease progression was defined as the time from the date of the first dose of study drug (overall reference start date) to the date of the first occurrence of evaluable PD. Time to disease progression was estimated using Kaplan-Meier statistics.

Outcome measures

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=45 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=13 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Time to Disease Progression	6.5 months Interval 3.7 to 9.3	4.4 months Interval 2.8 to 12.2	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.

Population: The mITT Analysis Set included all patients considered to be valid for the Safety Analysis Set and who received at least 1 dose of study drug at the MTD as the initial dose. Only patients who had information about PFS at the time of EOT (29 October 2019) were reported.

The PFS was defined as the time from the date of the first dose of melflufen (overall reference start date) to the date of the first occurrence of any disease response assessment available for PD or death. The PFS was estimated using Kaplan-Meier statistics.

Outcome measures

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=45 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=13 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Median Progression-Free Survival (PFS)	5.7 months Interval 3.7 to 9.2	4.4 months Interval 2.8 to 7.6	—	—	—	—

SECONDARY outcome

Timeframe: From baseline until death. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.

Population: The mITT Analysis Set included all patients considered to be valid for the Safety Analysis Set and who received at least 1 dose of study drug at the MTD as the initial dose. Only patients who had information about OS at the time of EOT(29 October 2019) were reported.

The OS was defined as the time from the date of the first dose of melflufen (overall reference start date) to death. The OS was estimated using Kaplan-Meier statistics.

Outcome measures

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=45 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=13 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Median Overall Survival (OS)	20.7 months Interval 11.8 to 41.3	15.5 months Interval 4.9 to 23.4	—	—	—	—

SECONDARY outcome

Timeframe: From baseline until start of first subsequent treatment. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.

Population: The mITT Analysis Set included all patients considered to be valid for the Safety Analysis Set and who received at least 1 dose of study drug at the MTD as the initial dose. Only patients who had information about first subsequent treatment at the time of EOT (29 October 2019) were reported.

Time to first subsequent treatment start was defined as the time from the date of the actual end of treatment to the date of the first subsequent treatment. Time to first subsequent treatment was estimated using Kaplan-Meier statistics.

Outcome measures

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=45 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=13 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Time to First Subsequent Treatment	10.5 months Interval 7.9 to 12.2	10.7 months Interval 5.3 to Upper limit of confidence could not be calculated as it was not reached.	—	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months.

Population: The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.

An adverse event (AE) was any untoward medical occurrence in a study patient administered an investigational product and that does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was defined as any AE, occurring at any dose, that met any one or more of the following criteria: is fatal or immediately life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization; or other important medical event. TEAEs were defined as AEs that started or worsened on or after the first dose of study drug (overall reference start date) up to and including the actual EOT date. TESAEs = Treatment emergent serious adverse events.

Outcome measures

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=4 Participants Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=7 Participants Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone n=6 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone n=6 Participants Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone n=45 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) n=13 Participants Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Number of Patients With Treatment Emergent Adverse Events (TEAEs) TEAEs (including both serious and non-serious AEs)	4 Participants	7 Participants	6 Participants	6 Participants	45 Participants	13 Participants
Number of Patients With Treatment Emergent Adverse Events (TEAEs) TEAEs leading to death	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Patients With Treatment Emergent Adverse Events (TEAEs) TESAEs	3 Participants	4 Participants	2 Participants	4 Participants	17 Participants	9 Participants
Number of Patients With Treatment Emergent Adverse Events (TEAEs) DLT TEAEs	0 Participants	0 Participants	0 Participants	4 Participants	—	—
Number of Patients With Treatment Emergent Adverse Events (TEAEs) TEAEs related to melflufen and/or dexamethasone	4 Participants	7 Participants	6 Participants	6 Participants	45 Participants	13 Participants
Number of Patients With Treatment Emergent Adverse Events (TEAEs) TESAEs related to melflufen and/or dexamethasone	3 Participants	4 Participants	2 Participants	4 Participants	17 Participants	9 Participants

Adverse Events

Phase I: Melflufen 15 mg + Dexamethasone

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Phase I: Melflufen 25 mg + Dexamethasone

Serious events: 4 serious events

Other events: 7 other events

Deaths: 5 deaths

Phase I: Melflufen 40 mg + Dexamethasone

Serious events: 2 serious events

Other events: 6 other events

Deaths: 2 deaths

Phase I: Melflufen 55 mg + Dexamethasone

Serious events: 4 serious events

Other events: 6 other events

Deaths: 5 deaths

Phase I + II: Melflufen 40 mg + Dexamethasone

Serious events: 17 serious events

Other events: 45 other events

Deaths: 30 deaths

Phase II: Melflufen 40 mg (Single Agent)

Serious events: 9 serious events

Other events: 12 other events

Deaths: 10 deaths

Serious adverse events

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=4 participants at risk Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=7 participants at risk Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone n=6 participants at risk Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone n=6 participants at risk Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone n=45 participants at risk Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) n=13 participants at risk Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Infections and infestations Pneumonia	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	11.1% 5/45 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Bacteraemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Cystitis	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Escherichia bacteraemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Sepsis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Urinary tract infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	50.0% 3/6 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Febrile neutropenia	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Bone lesion	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Pyrexia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Renal and urinary disorders Renal failure	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Vascular disorders Deep vein thrombosis	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Escherichia sepsis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Catheter site infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Parainfluenzae virus infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Pseudomonal sepsis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	15.4% 2/13 • Number of events 10 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations White blood cell count decreased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Nervous system disorders Spinal cord compression	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.

Other adverse events

Measure	Phase I: Melflufen 15 mg + Dexamethasone n=4 participants at risk Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 25 mg + Dexamethasone n=7 participants at risk Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 40 mg + Dexamethasone n=6 participants at risk Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I: Melflufen 55 mg + Dexamethasone n=6 participants at risk Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	Phase I + II: Melflufen 40 mg + Dexamethasone n=45 participants at risk Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	Phase II: Melflufen 40 mg (Single Agent) n=13 participants at risk Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Psychiatric disorders Confusional state	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 2/4 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	85.7% 6/7 • Number of events 9 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	66.7% 4/6 • Number of events 26 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	83.3% 5/6 • Number of events 35 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	73.3% 33/45 • Number of events 154 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	69.2% 9/13 • Number of events 30 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Neutropenia	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	42.9% 3/7 • Number of events 7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	50.0% 3/6 • Number of events 12 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	100.0% 6/6 • Number of events 26 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	68.9% 31/45 • Number of events 115 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	69.2% 9/13 • Number of events 25 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Anaemia	75.0% 3/4 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	57.1% 4/7 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	50.0% 3/6 • Number of events 6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	64.4% 29/45 • Number of events 96 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	38.5% 5/13 • Number of events 14 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Lymphopenia	25.0% 1/4 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Leukopenia	25.0% 1/4 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Anaemia vitamin B12 deficiency	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	66.7% 4/6 • Number of events 6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	66.7% 4/6 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	26.7% 12/45 • Number of events 14 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	15.4% 2/13 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Constipation	50.0% 2/4 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	42.9% 3/7 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	15.6% 7/45 • Number of events 8 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	66.7% 4/6 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	20.0% 9/45 • Number of events 10 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	15.4% 2/13 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	11.1% 5/45 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Oral pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Fatigue	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	42.9% 3/7 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	50.0% 3/6 • Number of events 7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	28.9% 13/45 • Number of events 20 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	30.8% 4/13 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Pyrexia	50.0% 2/4 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	35.6% 16/45 • Number of events 19 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Mucosal inflammation	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	13.3% 6/45 • Number of events 8 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Hyperthermia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Asthenia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	31.1% 14/45 • Number of events 46 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Chest pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Influenza like illness	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	8.9% 4/45 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Non-cardiac chest pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Oedema peripheral	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	42.9% 3/7 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	13.3% 6/45 • Number of events 9 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	15.4% 2/13 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	11.1% 5/45 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	13.3% 6/45 • Number of events 8 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	11.1% 5/45 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Bursitis	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Bronchitis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	11.1% 5/45 • Number of events 6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Candida infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Cystitis	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Enterococcal infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Gingivitis	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Influenza	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Mucosal infection	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Oral candidiasis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Oral fungal infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Periodontitis	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Skin and subcutaneous tissue disorders Night sweats	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Blood creatinine increased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	42.9% 3/7 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations White blood cell count decreased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	8.9% 4/45 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	23.1% 3/13 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Blood bilirubin increased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Blood glucose increased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Cardiac murmur	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Protein total increased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Psychiatric disorders Insomnia	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	13.3% 6/45 • Number of events 8 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Psychiatric disorders Sleep disorder	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Psychiatric disorders Anxiety	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Psychiatric disorders Nervousness	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	33.3% 2/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	13.3% 6/45 • Number of events 6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	17.8% 8/45 • Number of events 11 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	13.3% 6/45 • Number of events 8 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Nervous system disorders Dizziness	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	8.9% 4/45 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Nervous system disorders Headache	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	13.3% 6/45 • Number of events 8 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Nervous system disorders Paraesthesia	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	14.3% 1/7 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Nervous system disorders Presyncope	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Renal and urinary disorders Dysuria	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Cardiac disorders Palpitations	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Eye disorders Vision blurred	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	16.7% 1/6 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Hepatobiliary disorders Cholecystitis	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Reproductive system and breast disorders Erectile Dysfunction	25.0% 1/4 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Application site erosion	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Chills	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Feeling cold	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
General disorders Mucous membrane disorder	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Abdominal hernia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Aerophagia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Gastrointestinal disorders Gastric disorder	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Pneumonia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	8.9% 4/45 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Oral herpes	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Herpes zoster	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Acarodermatitis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Administration site infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Conjunctivitis bacterial	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Eye infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Furuncle	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Gastroenteritis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Gastroenteritis viral	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Herpes virus infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Laryngitis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Lung infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Sinusitis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Skin infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations C-reactive protein increased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	8.9% 4/45 • Number of events 5 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations CD4 lymphocytes decreased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Weight decreased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Fibrin d dimer increased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations International normalised ratio increased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Lymphocyte count decreased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Red blood cell count decreased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Urine output decreased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Vitamin B12 decreased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Investigations Weight increased	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	8.9% 4/45 • Number of events 13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Cachexia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Nervous system disorders Neuropathy peripheral	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	8.9% 4/45 • Number of events 4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Nervous system disorders Ataxia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Nervous system disorders Somnolence	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Nervous system disorders Tremor	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Psychiatric disorders Mood altered	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Psychiatric disorders Depression	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Psychiatric disorders Restlessness	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Vascular disorders Hypertension	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	6.7% 3/45 • Number of events 3 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Vascular disorders Hypotension	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	4.4% 2/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Vascular disorders Flushing	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Vascular disorders Haematoma	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Vascular disorders Thrombophlebitis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Vascular disorders Venous thrombosis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Renal and urinary disorders Renal failure	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Renal and urinary disorders Haematuria	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Cardiac disorders Mitral valve disease mixed	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Immune system disorders Immune system disorder	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Product Issues Device occlusion	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/45 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	7.7% 1/13 • Number of events 1 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/7 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/6 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	2.2% 1/45 • Number of events 2 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.	0.00% 0/13 • From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months. The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.

Additional Information

Eva Nordström

Oncopeptides AB

Phone: +4686152040

Email: trials@oncopeptides.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place