Trial Outcomes & Findings for Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer (NCT NCT00521404)

Last Updated: 2021-04-08

Results Overview

Progression-free survival rate (PFS) was defined as the time from the date of the first administration of the study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first at 16 weeks post-treatment with CS-1008.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.

Results posted on

2021-04-08

Participant Flow

A total of 65 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 12 clinic sites in the United States of America. Three (3) of the participants were not treated with the study drug. The data on the 62 treated participants are presented in this report.

Three participants were enrolled but later failed entry criteria. They did not receive treatment and were not included in this analysis.

Participant milestones

Participant milestones
Measure	CS-1008 + Gemcitabine Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Overall Study STARTED	62
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	62

Reasons for withdrawal

Reasons for withdrawal
Measure	CS-1008 + Gemcitabine Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Overall Study Adverse Event	13
Overall Study Disease Progression	33
Overall Study Investigator decision	5
Overall Study Withdrawal of consent	3
Overall Study Noncompliance or lack of cooperation	1
Overall Study Other	7

Baseline Characteristics

Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CS-1008 + Gemcitabine n=62 Participants Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Age, Continuous	60.7 years STANDARD_DEVIATION 10.85 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.

Population: The progression-free survival rate was assessed in the Per-Protocol Analysis Set.

Outcome measures

Outcome measures
Measure	CS-1008 + Gemcitabine n=61 Participants Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer	52.5 Percentage of participants Interval 39.3 to 64.1

SECONDARY outcome

Timeframe: Baseline up to date of disease progression or death due to any cause (whichever occurs first), up to approximately 36 months post dose.

Population: Progression-free survival was assessed in the Per-Protocol Analysis Set.

PFS (Progression-free survival) was defined as the time from the date of the first administration of study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first.

Outcome measures

Outcome measures
Measure	CS-1008 + Gemcitabine n=61 Participants Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer PFS Rate at 1 Year (%)	13.1 Percentage of participants Interval 6.1 to 22.8
Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer PFS Rate at 3 Months (%)	59.0 Percentage of participants Interval 45.7 to 70.1
Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer PFS Rate at 6 Months (%)	34.4 Percentage of participants Interval 22.9 to 46.3
Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer PFS Rate at 9 Months (%)	21.3 Percentage of participants Interval 12.1 to 32.2

SECONDARY outcome

Timeframe: Baseline to death due to any cause, up to approximately 36 months post dose.

Population: Overall survival was assessed in the Per-Protocol Analysis Set.

OS (Overall Survival) was defined as the time from the date of the first administration of study drug (Day 1) to the date of death. If there was no death reported for a subject before the cut-off date for overall survival analysis, overall survival was censored at the last contact date at which the subject was known to be alive.

Outcome measures

Outcome measures
Measure	CS-1008 + Gemcitabine n=61 Participants Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer OS Rate at 6 Months (%)	55.7 Percentage of participants Interval 42.4 to 67.1
Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer OS Rate at 9 Months (%)	41.0 Percentage of participants Interval 28.6 to 52.9
Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer OS Rate at 1 Year (%)	24.6 Percentage of participants Interval 14.7 to 35.9
Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer OS Rate at 15 Months (%)	13.1 Percentage of participants Interval 6.1 to 22.8

SECONDARY outcome

Timeframe: Baseline to up to date of first documented objective response or disease progression (whichever occurs first), up to approximately 36 months post dose.

Population: The best overall tumor response was assessed in the Per-Protocol Analysis Set.

The best overall response the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease\[PD\]) among all overall responses recorded from the start of treatment until the subject withdrew from the study. If there was no tumor assessment after the first infusion of study drug and no clinical disease progression recorded, the best overall response was classified as Unknown. CR was defined as the disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, PD was defined as at least a 20% increase in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease PD according to RECIST guideline (version 1.1).

Outcome measures

Outcome measures
Measure	CS-1008 + Gemcitabine n=61 Participants Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer Confirmed CR	0 Participants
Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer Confirmed PR	5 Participants
Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer Unconfirmed PR	3 Participants
Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer Objective Response (confirmed CR or PR)	5 Participants
Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer Unconfirmed CR	0 Participants
Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer Stable Disease (SD)	28 Participants
Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer Progressive Disease (PD)	14 Participants
Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer Unknown	11 Participants

SECONDARY outcome

Timeframe: Baseline up to 30 days post last dose, up to approximately 36 months post dose.

Population: Treatment-Emergent Adverse Events were assessed in the safety analysis set.

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that: emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment or worsens in severity during treatment relative to the pre-treatment state when the AE was continuous. The AEs with an onset date on Day 1 (the date on which the first dose of study medication was administered) were counted as a TEAE. An AE that occurred more than 30 days after the last dose of study medication was not included as a TEAE unless it was considered drug-related. A TEAE was considered related to CS-1008 or gemcitabine if the investigator considered the event as possibly, probably, or definitely related to treatment, or if the investigator's assessment of the relationship was unknown.

Outcome measures

Outcome measures
Measure	CS-1008 + Gemcitabine n=62 Participants Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Any TEAE	43 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Pyrexia	10 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Rash	4 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Anemia	8 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Neutropenia	4 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Thrombocytopenia	5 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Abdominal Pain	5 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Constipation	8 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Diarrhea	8 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Nausea	22 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Vomiting	8 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Asthenia	11 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Fatigue	20 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Oedma peripheral	12 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Haemoglobin decreased	6 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Neutrophil count decreased	5 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term White blood cell count decreased	4 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Anorexia	8 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Dysgeusia	4 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Headache	6 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term Hypertension	4 Participants

SECONDARY outcome

Timeframe: Baseline up to 30 days post last dose, up to approximately 36 months post dose.

Population: Treatment-emergent adverse event was assessed in the safety analysis set.

Outcome measures

Outcome measures
Measure	CS-1008 + Gemcitabine n=62 Participants Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Leukopenia	4 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Thrombocytopenia	11 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Abdominal distension	4 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Vomiting	20 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Fatigue	22 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Haemoglobin decreased	10 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Platelet count decreased	9 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Any TEAE	54 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Anemia	15 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Lymphopena	5 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Abdominal pain	5 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Constipation	7 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Diarrhea	11 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Nausea	31 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Asthenia	12 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Chills	5 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Oedema peripheral	10 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Pyrexia	11 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Neutrophil count decreased	9 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term White blood cell count decreased	7 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Anorexia	8 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Dehydration	5 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Dysgeusia	4 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Headache	6 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Alopecia	4 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Night Sweats	4 Participants
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term Rash	5 Participants

Adverse Events

CS-1008 + Gemcitabine

Serious events: 35 serious events

Other events: 62 other events

Deaths: 61 deaths

Serious adverse events

Serious adverse events
Measure	CS-1008 + Gemcitabine n=62 participants at risk Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Blood and lymphatic system disorders Anaemia	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Cardiac disorders Atrial fibrillation	3.2% 2/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Abdominal Pain	8.1% 5/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Nausea	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Vomiting	3.2% 2/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Disease Progression	3.2% 2/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Pyrexia	3.2% 2/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Hepatobiliary disorders Cholangitis	3.2% 2/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Infections and infestations Clostridium difficile colitis	3.2% 2/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Infections and infestations Pneumonia	3.2% 2/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Infections and infestations Urinary tract infection	3.2% 2/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Metabolism and nutrition disorders Dehydration	3.2% 2/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	4.8% 3/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Nervous system disorders Cerebral infarction	1.6% 1/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Psychiatric disorders Confusional State	1.6% 1/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Renal and urinary disorders Renal Failure	1.6% 1/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.6% 1/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Lung infiltration	1.6% 1/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 1/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 1/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 1/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Vascular disorders Peripheral vascular disorder	1.6% 1/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.

Other adverse events

Other adverse events
Measure	CS-1008 + Gemcitabine n=62 participants at risk Chemotherapy-naïve participants with unresectable or metastatic pancreatic cancer who were administered CS-1008 once weekly without rest, and Gemcitabine once weekly for 3 weeks followed by 1 week of rest. CS-1008 was administered first. Gemcitabine was then administered immediately after completion of the CS-1008 infusion.
Blood and lymphatic system disorders Anaemia	33.9% 21/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Blood and lymphatic system disorders Leukopenia	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Blood and lymphatic system disorders Lymphopenia	8.1% 5/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Blood and lymphatic system disorders Neutropenia	24.2% 15/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Blood and lymphatic system disorders Thrombocytopenia	22.6% 14/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Cardiac disorders Tachycardia	8.1% 5/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Eye disorders Visual impairment	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Abdominal distension	17.7% 11/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Abdominal pain	51.6% 32/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Abdominal pain upper	12.9% 8/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Ascites	16.1% 10/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Constipation	50.0% 31/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Diarrhea	38.7% 24/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Dry Mouth	8.1% 5/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Dyspepsia	19.4% 12/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Dysphagia	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Flatulence	11.3% 7/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Nausea	75.8% 47/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Oral pain	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Gastrointestinal disorders Vomiting	54.8% 34/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Asthenia	27.4% 17/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Chest discomfort	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Chest pain	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Chills	16.1% 10/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Fatigue	69.4% 43/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Malaise	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Mucosal inflammation	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Oedema	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Oedema Peripheral	40.3% 25/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Pain	14.5% 9/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
General disorders Pyrexia	48.4% 30/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Hepatobiliary disorders Jaundice	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Infections and infestations Pneumonia	8.1% 5/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Infections and infestations Sinusitis	8.1% 5/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Infections and infestations Upper respiratory tract infection	9.7% 6/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Infections and infestations Urinary tract infection	11.3% 7/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Injury, poisoning and procedural complications Procedural pain	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Investigations Alanine aminotransferase increased	11.3% 7/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Investigations Aspartate aminotransferase increased	8.1% 5/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Investigations Gamma-glutamyltranferase increased	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Investigations Haemoglobin decreased	16.1% 10/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Investigations Neutrophil count decreased	14.5% 9/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Investigations Platelet count decreased	14.5% 9/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Investigations Weight decreased	21.0% 13/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Investigations Weight increased	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Investigations White blood cell count decrased	11.3% 7/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Metabolism and nutrition disorders Anorexia	35.5% 22/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Metabolism and nutrition disorders Dehydration	22.6% 14/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Metabolism and nutrition disorders Hyperglycaemia	9.7% 6/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Metabolism and nutrition disorders Hypocalcaemia	8.1% 5/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Metabolism and nutrition disorders Hyponatraemia	16.1% 10/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Musculoskeletal and connective tissue disorders Artralgia	11.3% 7/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Musculoskeletal and connective tissue disorders Back pain	24.2% 15/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Musculoskeletal and connective tissue disorders Muscle spasms	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Musculoskeletal and connective tissue disorders Myalgia	8.1% 5/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Musculoskeletal and connective tissue disorders Pain in extremity	12.9% 8/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Nervous system disorders Dizziness	14.5% 9/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Nervous system disorders Dysgeusia	11.3% 7/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Nervous system disorders Headache	22.6% 14/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Nervous system disorders Neuropathy peripheral	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Psychiatric disorders Anxiety	29.0% 18/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Psychiatric disorders Depression	16.1% 10/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Psychiatric disorders Insomnia	24.2% 15/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Cough	24.2% 15/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.8% 16/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	11.3% 7/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Rales	6.5% 4/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Respiratory, thoracic and mediastinal disorders Sinus congestion	9.7% 6/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Skin and subcutaneous tissue disorders Alopecia	9.7% 6/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Skin and subcutaneous tissue disorders Hyperhidrosis	9.7% 6/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Skin and subcutaneous tissue disorders Night sweats	9.7% 6/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Skin and subcutaneous tissue disorders Rash	14.5% 9/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Vascular disorders Hypertension	9.7% 6/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.
Vascular disorders Hypotension	11.3% 7/62 • Adverse events (AE) were collected and reported from when the first dose of study drug was administered to 30 days after the last dose of study drug. Treatment-emergent AE (TEAE) and serious AE data were collected from baseline up to 36 months postdose. A treatment-emergent AE (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug until 30 days after last dose of the study drug, unless it was considered drug related.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place