Trial Outcomes & Findings for Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00413283)

Last Updated: 2013-10-24

Results Overview

This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

4 months

Results posted on

2013-10-24

Participant Flow

Participants were enrolled from 28 December 2006 through 11 August 2008.

Participant milestones

Participant milestones
Measure	Placebo Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Overall Study STARTED	12	16	18	17
Overall Study Received Study Drug	12	16	18	16
Overall Study COMPLETED	11	13	16	13
Overall Study NOT COMPLETED	1	3	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Overall Study Withdrawal by Subject	1	0	0	1
Overall Study Death	0	0	1	1
Overall Study Adverse Event	0	0	0	1
Overall Study Ineligibility determined	0	0	0	1
Overall Study Protocol deviation	0	1	0	0
Overall Study Requirement for alternative therapy	0	2	0	0
Overall Study Other	0	0	1	0

Baseline Characteristics

Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=12 Participants Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg n=16 Participants Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg n=18 Participants Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg n=17 Participants Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Total n=63 Participants Total of all reporting groups
Age Continuous	59.8 Years STANDARD_DEVIATION 6.6 • n=5 Participants	63.8 Years STANDARD_DEVIATION 10.8 • n=7 Participants	62.5 Years STANDARD_DEVIATION 7.7 • n=5 Participants	65.4 Years STANDARD_DEVIATION 8.2 • n=4 Participants	63.1 Years STANDARD_DEVIATION 8.5 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	15 Participants n=4 Participants	45 Participants n=21 Participants
Race/Ethnicity, Customized White or Caucasian	12 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants	17 Participants n=4 Participants	62 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Safety Analysis Set, composed of all randomized participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg n=16 Participants Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg n=18 Participants Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg n=16 Participants Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Number of Participants With Adverse Events	12 Participants	16 Participants	18 Participants	14 Participants

SECONDARY outcome

Timeframe: 3 weeks

Population: Efficacy Analysis Set, composed of all randomized participants except those who were replaced (participants who discontinued prior to the completion of at least 1 romiplostim treatment cycle for non-platelet-related reasons).

The duration of grade 3 or 4 thrombocytopenia (defined as platelet count \<50 x 10\^9/L) experienced during the first on study chemotherapy cycle by treatment group.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg n=15 Participants Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg n=18 Participants Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg n=16 Participants Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Duration of Grade 3 or 4 Thrombocytopenia	2.1 days Standard Deviation 3.3	3.6 days Standard Deviation 4.3	2.6 days Standard Deviation 3.9	2.1 days Standard Deviation 2.7

SECONDARY outcome

Timeframe: 3 weeks

Population: Efficacy Analysis Set, composed of all randomized participants except those who were replaced.

The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count \< 50 x 10\^9/L, but ≥ 25 x 10\^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count \< 25 x 10\^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg n=15 Participants Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg n=18 Participants Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg n=16 Participants Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.	5 Participants	7 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 3 weeks

Population: Efficacy Analysis Set, composed of all randomized participants except those who were replaced.

Number of participants who were administered platelet transfusions during first on study treatment cycle.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg n=15 Participants Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg n=18 Participants Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg n=16 Participants Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Number of Participants With Platelet Transfusions	1 Participants	4 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 22

Population: Efficacy Analysis Set, composed of all randomized participants except those who were replaced

Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg n=15 Participants Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg n=18 Participants Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg n=16 Participants Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Platelet Count on Day 22	281.2 10^9/L Standard Deviation 116.0	222.6 10^9/L Standard Deviation 112.0	412.8 10^9/L Standard Deviation 295.2	336.0 10^9/L Standard Deviation 254.9

SECONDARY outcome

Timeframe: 8 days

Population: Efficacy Analysis Set, composed of all randomized participants except those who were replaced.

Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg n=15 Participants Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg n=18 Participants Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg n=16 Participants Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle	2 Participants	4 Participants	4 Participants	5 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Romiplostim 250 µg

Serious events: 7 serious events

Other events: 16 other events

Deaths: 0 deaths

Romiplostim 500 µg

Serious events: 5 serious events

Other events: 17 other events

Deaths: 0 deaths

Romiplostim 750 µg

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Placebo n=12 participants at risk Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg n=16 participants at risk Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg n=18 participants at risk Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg n=16 participants at risk Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Blood and lymphatic system disorders Anaemia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.8% 3/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Neutropenia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	8.3% 1/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 4/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cyanosis	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Retinal artery occlusion	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchopneumonia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Catheter related infection	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sepsis	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood creatinine increased	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Anxiety	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal impairment	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 2/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypotension	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events
Measure	Placebo n=12 participants at risk Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 250 µg n=16 participants at risk Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 500 µg n=18 participants at risk Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Romiplostim 750 µg n=16 participants at risk Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Infections and infestations Respiratory tract infection	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Skin infection	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Anaemia	50.0% 6/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	43.8% 7/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	38.9% 7/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	31.2% 5/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Granulocytopenia	16.7% 2/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 2/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukocytosis	8.3% 1/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukopenia	33.3% 4/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 4/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.2% 4/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 2/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Neutropenia	16.7% 2/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.8% 3/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 3/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	31.2% 5/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocythaemia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 4/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 8/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	44.4% 8/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 8/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Arrhythmia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure congestive	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Palpitations	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Ear disorder	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Eyelid oedema	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Lacrimation increased	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Vision blurred	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal distension	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	16.7% 2/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 2/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 2/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 2/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dysphagia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Flatulence	8.3% 1/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	8.3% 1/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 4/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.8% 5/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 2/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oral pain	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Retching	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Stomatitis	8.3% 1/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	25.0% 3/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 4/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Catheter site pain	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Catheter site swelling	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest discomfort	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chills	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.6% 1/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Face oedema	0.00% 0/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	8.3% 1/12 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	31.2% 5/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.2% 4/18 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 1/16 • From signing of the informed consent through 30 days after the last dose of investigational product or end of study, whichever is longer (up to 4 months). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.